Abstract
There are significant stressors related to parenting a young child with newly diagnosed type 1 diabetes (T1D). Despite these challenges, there are not yet clearly defined interventions to help promote psychological health and adherence for families with young children with T1D. First STEPS is a tailored stepped care design intervention to positively impact parents’ emotional functioning and children’s glycemic control in young children newly diagnosed with T1D. The First STEPS intervention is derived from a combination of Cognitive Behavioral Theory and Social Cognitive Theory to support family adjustment to T1D, promote parental mastery over T1D tasks, increase coping skills to manage stressors associated with T1D, and build on the strengths of families newly diagnosed with T1D to help them achieve positive health and wellbeing outcomes. We present details about the intervention and describe two pilot participants as case studies. Results indicated that the treatment and delivery model were acceptable to the pilot participants, as evidenced by treatment completion and satisfaction ratings. Future directions for this work include testing the efficacy of this new treatment in a randomized controlled trial.
Parenting young children can be challenging and adding a complex chronic illness such as diabetes can feel overwhelming for many parents (Whittemore et al., 2012; Sullivan-Bolyai et al., 2003). Type 1 diabetes (T1D) is one of the most common chronic illnesses diagnosed in childhood, occurring in 1 in every 400–600 children in the United States, and prevalence is increasing in young children under 5 (Dabelea et al., 2014; Mayer-Davis et al., 2017). Diabetes management includes coordination of a complex series of disease care actions, including frequent monitoring of glucose levels, calculation of carbohydrates in snacks/meals, computation of the needed amount of insulin and administering it via injection or a medical device (insulin pump), and close attention to physical activity levels (American Diabetes Association, 2020; Sullivan-Bolyai et al., 2002). To develop and maintain the needed health regimen, families need to coordinate a complex set of behaviors.
Parents describe the daily demands of their routine of managing diabetes for their young child (< 6 years) as unrelenting and requiring “constant vigilance” (Sullivan-Boylai et al., 2003). Inherent developmental challenges of early childhood, including unpredictable diet, sleep, and physical activity patterns, increased insulin sensitivity, variable language skills, and social and behavioral development, present significant challenges to optimal T1D management and outcomes in young children (Streisand & Monaghan, 2014). For example, in toddlers and preschoolers, developmentally normal variations in dietary preferences (e.g., transient picky eating) can make adhering to the daily regimen difficult for families. In addition, youth with T1D demonstrate more behavioral problems surrounding mealtimes (Streisand & Monaghan, 2014). The stakes of not fully executing the tasks of diabetes management are high, as over- or underdosing insulin (e.g., due to not eating the expected amount of food, requiring very small insulin doses) can result in acute and long-term complications.
Despite these many behavioral challenges, there are not yet clearly defined interventions or treatment manuals to help promote psychological health and health behaviors for families with young children with T1D. A meta-analysis of 15 interventions promoting health behaviors in children and adolescents with T1D concluded there is a small effect for behavioral interventions, with a stronger effect for multicomponent interventions that target emotional, social, and family processes promoting diabetes health behaviors (Hood et al., 2010). However, just 2 of those 15 interventions included young children. Therefore, multicomponent interventions have yet not been fully evaluated in families of young children. While most psychological interventions have focused on school-aged children and older, there is promising evidence from a few small behavioral interventions, including from our own team, to provide support for parents of young children with T1D (Mackey et al., 2016; Monaghan et al., 2011). To continue to address this gap in behavioral intervention research, we developed First STEPS, a tailored intervention designed to positively impact parents’ emotional functioning and children’s glycemic control in young children newly diagnosed with T1D. Elsewhere, we describe this two-site stepped-care randomized clinical trial study design protocol (Hilliard et al., 2017). Given the need for higher levels of treatment-related details of behavioral interventions in efforts to improve clinical care, our research team aimed to provide further information about our ongoing study.
The First STEPS intervention is incrementally intensive and delivered by trained peer parent coaches (Step 1), master’s-level research telephone counselors (Step 2), and a registered nurse or master’s-level Certified Diabetes Educators and doctoral-level clinical psychologists (Step 3) occurring in person or by telemedicine, as needed. Stepped-care models were developed for limited resource systems to deliver only the amount of intervention an individual needs to experience benefit (Haaga, 2000). This is in line with the Pediatric Psychosocial Preventative Health Model (Kazak, 2006), which recommends universal screening and stepped-care interventions as part of pediatric clinical care. In the next section, we provide a brief review of the behavioral challenges and parenting stress related to the diagnosis of T1D in a young child. Following, we discuss the research design and cognitive-behavioral intervention details of the First STEPS intervention. As the RCT is ongoing, we illustrate the preliminary evidence of feasibility by reporting case examples of two study participants who received different levels of the intervention based on their needs, demonstrating how the treatment is implemented with regards to parent and child response to the intervention.
Review of Behavioral Challenges and Parenting Stress in Families With Young Children With T1D
The T1D diagnosis experience can be traumatic for parents, and many parents report feelings of fear, anger, guilt, helplessness, and grief (Whittemore et al., 2012). Young children are often critically ill at the time of diagnosis, with 44% of those under 6 presenting in diabetic ketoacidosis (DKA), a potentially life-threatening condition in which blood glucose is extremely elevated and bodily functions are compromised (Quinn et al., 2006). Parents grapple with having a child with a disease that does not currently have a cure, and some experience feelings of guilt surrounding genetic influences related to T1D disease development (Lowes et al., 2004; Mullins et al., 2004). During this stressful period, parents also must quickly learn diabetes management skills (i.e., administering insulin, inserting diabetes technology devices) to safely care for their child. Following diagnosis, many parents report job changes, school/childcare alterations, increases in marital conflict, and increases in financial stress (Bowes et al., 2009). The ongoing stress and worry manifest in elevated rates of parents’ perception of stress and increased risk for depression and anxiety (Whittemore et al., 2012). Parent experiences can interfere with their ability to learn and process the complex diabetes management education necessary to keep their child healthy after hospital discharge (Schwartz et al., 2011). Further, parent psychological distress at the time of diagnosis predicts parent distress (Whittemore et al., 2012), thus emphasizing the need for targeted support surrounding the time of the diagnosis.
Families describe the challenges with walking the metabolic tightrope to achieve blood glucose levels in a recommended range and avoiding dangerously low or high levels. Parents of young children with T1D describe being afraid of hypoglycemia (extremely low blood glucose), particularly relating to young children’s lack of physiological awareness and verbal abilities to describe how they are feeling and ask for assistance, as well as concerns about not being aware of dangerous overnight low blood glucose levels (Sullivan-Boylai et al., 2002; Van Name et al., 2018). The consequences of hypoglycemia can include irritability, shakiness, seizures, cognitive effects, and even death (Patton et al., 2008). While some degree of concern is necessary to avoid unsafe low blood glucose levels, more intense fears of hypoglycemia can lead to changes in family routines to accommodate anxious thoughts and hypervigilant behaviors, as well as reduced quality of life (Driscoll et al., 2016; Sullivan-Boylai et al., 2002). Unpredictable eating is a common source of stress for parents, as transient food preferences and food refusal are typical in young children (Cathey & Gaylord, 2004). Insulin dosing, which is largely based on anticipated food consumption, can be extremely difficult to predict and administer accurately prior to the meal. Many parents choose to administer insulin after a meal to avoid worries of hypoglycemia if too little food is eaten after insulin is given, despite the fact that this can compromise achievement of blood glucose targets (Goonetilleke et al., 2004). To further avoid hypoglycemia, some parents may take actions to increase blood glucose levels (e.g., administering glucose) that can result in hyperglycemia, or high blood glucose levels (Van Name et al., 2019). Parents must balance any anxious cognitions regarding hypoglycemia with the consequences of hyperglycemia. Acutely, hyperglycemia can cause blurred vision, fatigue, and headache, and if left untreated can lead to DKA and confusion, nausea, abdominal pain and even coma (ADA, 2017). Chronic hyperglycemia over time has been associated with the development of microvascular and macrovascular complications (ADA, 2017). Reviews demonstrate the association among parent psychological distress, diabetes management behaviors, and glycemic control (Whittemore et al., 2012). In addition to being stressful, managing diabetes in young children is difficult and it is estimated that only 23% of young children meet the glycemic targets set by the American Diabetes Association (Miller et al., 2015).
Despite the growing prevalence and unique challenges of T1D management in early childhood, empirically supported patient education and counseling programs specifically designed for parents of young children newly diagnosed with T1D are not widely available, as most T1D clinical behavioral interventions limit trial participation to school-aged children or adolescents diagnosed for at least 6–12 months (Murphy et al., 2006). Over the past nearly 30 years, only a few small-scale clinical behavioral interventions for parents of young children with T1D have addressed this problem by offering parent social support via parent mentors (Kovacs et al., 1990; Sullivan-Bolyai et al., 2004), and our own telephone-based psychoeducational/behavioral intervention that focused on teaching skills to manage child behavior and parental stress related to T1D at diagnosis and later (Monaghan et al., 2011; Mackey et al., 2016). “Parent coaching” is the name for a structured peer parent-to-parent mentorship support program that has been used in multiple pediatric populations including obesity, gastroenterology, and diabetes (Tully et al., 2017). This approach is grounded in the principle of observational learning in social cognitive theory (SCT). SCT is a theory of learning that includes the individual’s knowledge of the risks and benefits of health behaviors, perceived self-efficacy that one can control one’s health behavior, outcome expectations about the costs/benefits of health behaviors, goal-setting, and the social and environmental facilitators of adaptive change. In SCT, a key facilitator to change is that individuals can learn from watching others and then reproduce that behavior themselves (observational learning; Bandura, 2004; Bandura & NIMH, 1986). Parent coaching can target each of these factors through modeling, as well as offering social support and information from a trusted source. Parent coach interventions have demonstrated increased perceived support, decreased family burden, and improved coping (Sullivan-Bolyai et al., 2004), as well as decreased parenting stress (Mackey et al., 2016). Despite the promising behavioral and psychosocial outcomes of previous intervention research using parent coaches, concomitant improvements in children’s glycemic outcomes remain elusive. Supplementing parent coaching with increasing intensity of professionally delivered behavioral intervention for parents who need more support may yield improved psychosocial and diabetes health outcomes. Thus, new or intensified approaches may be necessary to impact both parental well-being and child glycemic outcomes, particularly during the challenging period following diagnosis.
The goals of the First STEPS program were to support the adjustment of parents, and to positively impact children’s glycemic control, over approximately 9 months during the first year after T1D diagnosis. The aim of the project is to determine the longitudinal impact of the intervention on young children’s glycemic control and parent psychosocial functioning. The primary hypothesis is that the children of parents in the intervention condition will demonstrate significantly better glycemic outcomes and parents will demonstrate significantly better psychosocial functioning (e.g., fewer depressive symptoms, lower pediatric parenting stress) relative to participants in usual care. The purpose of this paper is to describe the theoretical underpinnings and clinical care components of First STEPS in detail, and to provide clinicians and clinical researchers with the specifics needed to implement the core principles of the intervention if desired.
Method
Participants
The target sample for this study included parents who self-identified as the primary caregivers for children ages 1 to 6 years old newly diagnosed with T1D (within 4–8 weeks of diagnosis date). Parents were the focus of the intervention and, therefore, were excluded if diagnosed with a serious mental illness (e.g., schizophrenia) or developmental disability that would limit participation. Similarly, children with T1D were excluded if diagnosed with an additional serious or life-threatening disease (e.g., cancer, cystic fibrosis) or developmental disability (e.g., autism, mental retardation) as assessed via parent report at the time of enrollment screening. Parents had to adequately understand, speak, and read English to participate given the unavailability of standardized Spanish language measurement tools. Study staff recruited participants at the time of diagnosis at two trial sites at children’s hospitals in major cities in northeastern and southern United States. Four families completed a preliminary pilot of the intervention and their data are presented here to demonstrate the intervention delivery. The trial is ongoing with a target enrollment of 150 primary caregivers of young children with T1D.
Measures
Parents completed baseline assessments within 2 months following diagnosis (see Table 1). Follow-up assessment took place at 3, 6, 9, and 15 months post enrollment (Hilliard et al., 2017, for full assessment details). Parents completed a psychosocial battery at each time point (e.g., depression, quality of life). Additionally, child health records were collected to measure glycemic control including hemoglobin A1c (hereafter: A1c), a biochemical analysis of the child’s average blood glucose concentration over the previous 2–3 months. The American Diabetes Association (ADA) recommends all children and adolescents maintain an A1c value <7.0% (ADA, 2020). Participants completed a battery of validated self-report questionnaires at three time points: baseline (close to the child’s diabetes diagnosis), first follow up (9 months later), and second follow-up (15 months; see Figure 1). Parents also completed a brief medical update and one questionnaire about parent mood at 3 and 6 months post enrollment. The primary outcomes were child glycemic control as measured by A1c and parent mood assessed with the Center for Epidemiologic Scale–Depression (CES-D; Radloff, 1977).
Table 1.
Psychosocial Assessments
Measure | Brief Description | Psychometric Information | BL | 3 mos | 6 mos | 9 mos | 15 mos |
---|---|---|---|---|---|---|---|
Center for Epidemiological Studies- Depression Scale (CESD) | Depressive symptoms | Adequate test-retest reliability; Cronbach’s α = .85–.90 (Radloff, 1977) | • | • | • | • | • |
PROMIS Emotional Distress – Anxiety – Short Form | Anxiety-related symptoms | Adequate test-retest reliability Cronbach’s α = .89 (Irwin et al., 2010) | • | • | • | ||
Behavioral Pediatrics Feeding Assessment Scale (BPFAS) | Mealtime and feeding behaviors, parent and child subscales | Adequate test-retest reliability Cronbach’s α = .74–.88 (Crist & Napier-Phillips, 2001). | • | • | • | ||
Pediatric Inventory for Parents (PIP) | Stress relating to parenting a child with a chronic illness | Used in T1D samples; Cronbach’s α = .80–.96 (Streisand, Braniecki, Tercyak, & Kazak, 2001; Lewin, Storch, Silverstein, Baumeister, Strawser, & Geffken, 2005). | • | • | • | ||
Perceived Stress Scale | Perceptions of stress | Adequate test-test reliability Cronbach’s α = .74–.91 (Lee, 2012; Cohen, Kamarch, & Mermelstein, 1983) | • | • | • | ||
Parents Diabetes Quality of Life Questionnaire (PDQOLQ) | Health-related quality of life relating to the impact, satisfaction, and worry related to diabetes management | Reliable and valid; Cronbach’s α = .64–.89; [90] | • | • | • | ||
Pediatric Quality of Life Inventory (PedsQL)- | Generic Core- Health related quality of life relating to: Physical, Emotional, Social, Academic functioning | Reliable and valid; Cronbach’s α = .86–.90 (Vandagriff, Marrero, Ingersoll, & Fineberg, 1992) | • | • | • | ||
Self-Efficacy for Diabetes Scale for Parents (SED-P) | Parental confidence in managing their child’s T1D | Cronbach’s α = .87; Significant associations between self-efficacy and parenting stress (Grossman, Brink, & Hauser, 1987). | • | • | • | ||
Hypoglycemia Fear Survey- Parents of Young Children (HFS-PYC) | 2 domains: Worry, Avoidance behaviors | Used for T1D of all ages (Cox, Irvine, Gonder-Frederick, Nowacek, & Butterfield, 1987); Cronbach’s α = .90 (Streisand et al., 2005) | • | • | • | ||
Pittsburgh Sleep Quality Inventory (PSQI) | Quality and patterns of sleep | Reliability estimates are good (alphas >.80) (Buysse, Reynolds, Monk, Burman, & Kupfer, 1989). | • | • | • | ||
Diabetes Co-Parenting Questionnaire (DCQ) | Diabetes specific co-parenting and functioning | Internal consistencies are acceptable; Cronbach’s α = .69 (Barzel & Reid, 2008). | • | • | • | ||
Eyberg Chid Behavior Inventory | Child problem behavior | High internal consistent in children with T1D; Cronbach’s α = .92 (Hilliard, Monaghan, Cogen & Streisand, 2011) | • | • | • | ||
Protective Factors Survey | Family functioning/resiliency and strengths | Reliability and validity in parents of young healthy children (retest reliability r>.42; r’s>.20 with parent questionnaire on health and stress (Counts et al., 2010) | • | • | • | ||
Social Problem Solving Inventory-Revised: Short Form | Self-report measure of social problem-solving | Internal consistencies are acceptable; Cronbach’s α = .76 (D’Zurilla, Nezu, & Maydeau-Oilvares, 2002) | • | • | • |
Figure 1.
Overview of the stepped care intervention.
To assess study acceptability, all pilot participants completed satisfaction surveys at the end of the intervention. Questions assessed general satisfaction with participation and with study procedures. Intervention group participants only completed satisfaction surveys for the steps they completed. There were eight questions asked about their satisfaction with Step 1 (parent coach), such as frequency of contacts, helpfulness of the coach, and the degree to which the coach increased their sense of self-efficacy to manage their child’s diabetes. Participants who received Step 2 (telephone-based counseling) also completed 18 questions about the amount of time needed to complete the calls, usefulness of each of the session’s main topics, their perception of the counselor as knowledgeable, flexible, warm and supportive, and general satisfaction questions (“Overall, my participation in Step 2 met my expectations”). The Step 3 satisfaction survey contained 11 questions asking participants to rate the helpfulness of the consultations and their perception of the diabetes educator and psychologist’s knowledge, helpfulness, and ability to make personalized recommendations. The questionnaire also asked if the family made changes after the Step 3 consultations and how much of the information received was new and relevant for the family. Parents were asked to state their agreement with statements on a Likert-type scale from 1 (strongly agree) to 5 (strongly disagree), and there were open-text boxes for each step asking participants to describe what they liked and any suggestions to improve the step.
All participants completed interviews after their final data collection. Interviews were performed by phone by staff unfamiliar with the participant and were audio-recorded. The interview guide was created by consensus by the study team and included probes about overall satisfaction with study participation, as well as specific questions about individual components of intervention procedures. Interviewers took field notes, which were deidentified and shared across the research team at both sites. Calls took 20–30 minutes and participants were compensated for participation.
Initial feasibility was defined as delivering the intervention as designed with fidelity within the time frame allotted. Parent retention in the program, responses on the satisfaction survey, and responses in the interview determined acceptability.
Treatment
Overview
This study used a stepped-care intervention design to provide the least intense treatment necessary for optimal outcomes by closely monitoring progress and enhancing, or “stepping up,” treatment when indicated, based on an algorithm with predetermined outcomes or goals (Bower & Gilbody, 2005; Richards et al., 2012). The multimodal, personally tailored, parent-focused intervention was designed to determine which level of intervention each individual needed based on parent mood and child glycemic control. The stepped-care intervention used a combination of cognitive behavioral theory (CBT) and SCT frameworks to support adjustment to T1D, promote parental mastery over T1D tasks, increase coping skills to manage stressors associated with T1D, and build on the strengths of families newly diagnosed with T1D to help them achieve positive health and well-being outcomes. A positive psychology perspective was interspersed throughout as all interventionists were trained to highlight family strengths to improve parent confidence and mastery over T1D tasks. Consistent with the literature on Positive Psychology Interventions that focus on what patients are capable of achieving (PPI; e.g., Macaskill, 2016), First STEPS aimed to increase hope in patients by supporting self-efficacy and connecting patients with social support and resources, and incorporated PPI—including gratitude exercise—by providing psychoeducation about the value of gratitude, engaging the parent in a conversation about what they are grateful for, and helping structure a daily written gratitude exercise.
Components of the First STEPS intervention were modeled after prior work from this research team (Tully et al., 2017) and others (Sullivan-Bolyai et al., 2010). The research team included pediatric psychologists, social workers, pediatric endocrinologists, diabetes nurse educators, and research staff. Clinical care team members with the diabetes program informed the content and delivery format of the steps of this intervention. In developing this multi-step approach, the study team discussed the goals of each step, reviewed prior intervention materials, and solicited clinical care team input. A Parent Advisory Board (3 parents of children with T1D) reviewed draft materials and provided feedback and recommendations. A graphic designer created a study logo and colorful bound booklet of the behavioral strategies to serve as a reference for parents in Step 2 of the intervention.
Participants were randomized to either the intervention condition or usual care on a 3:1 basis. All participants in the intervention group began in Step 1 immediately following randomization. Study staff met with participants at the next two diabetes clinic follow-up visits (typically scheduled approximately 2–4 months apart), at which time the child’s current A1c value was obtained from medical staff and the parent completed a measure of depressive symptoms (CES-D). At each visit, intervention group participants either remained in their current intervention step or advanced to a higher step if the child’s A1c value >8.0% and/or the parent depressive symptoms exceed the measure’s established clinical cutoff for mild depression (CES-D≥16; Radloff, 1977). Over the course of the 9-month intervention phase, participants could stay in Step 1, advance to Step 2 at the first or second follow-up, or advance to Step 2 at the first follow-up and to Step 3 at the second follow-up. Participants were not able to return to a lower step, but rather stayed in their current step if they did not meet criteria to advance. Participants in the usual care comparison condition were also assessed using the same measures and on the same schedule. See Figure 1 for an overview of the three levels to the stepped care intervention, and Table 2 for more detail on each intervention component.
Table 2.
Intervention Components
Step | Movement to this Step | Who delivers Intervention at this Step | Format | Length of Time in Step | Frequency of Contact | Components of Intervention at this Step |
---|---|---|---|---|---|---|
1 | Everyone in Intervention arm | Trained Parent Coaches | 1 in-person meeting, follow-ups by phone, email, text | 9 months | Weekly (3 months), then monthly | • Peer support • Connection to local resources |
2 | Elevated CES-D score and/or A1c above target 2–6 months after beginning step 1 | Masters-level behaviorally trained phone counselors | 4 individual telephone calls, 1 group call | 5–12 weeks | Approximately biweekly | • Psychoeducation about child development in context of diabetes • Instruction and practice of cognitive and behavioral strategies (e.g., relaxation, cognitive restructuring, problem-solving), • Positive psychology strategies (e.g., gratitude) |
3 | Elevated CES-D score and/or A1c above target 2–3 months after beginning step 2 | Certified Diabetes Educator nurses and Doctoral-level clinical psychologists | In-person or telephone consultations | 1–12 weeks | 3 contacts | • Individualized review of child’s glucose patterns via data from continuous glucose monitoring or finger stick monitoring • Individualized behavioral consultation and recommendations |
Step 1
The first step of the intervention included matching participants with a parent coach. Parent coaches were parents with children currently between 2–12 years old who had been diagnosed with T1D for at least a year and expressed a flexible and positive perspective towards diabetes management. Parent coaches were instructed to make contact with their assigned parents weekly for the first 3 months after the participant was randomized to the intervention, tapering to monthly contact for the remaining 6 months of the intervention period (9 months total). They were asked to make one in-person contact in the first month, when possible, with the rest of the contact made using telephone, text messages, and email.
Parent coaches provided logistical, emotional, and instrumental guidance by normalizing stress and providing resources to support parent participants as they adjust to T1D. The content covered between parent coaches and their parent participants was unscripted. This relationship with a parent coach aimed to help the participant develop self-efficacy and trust in their ability to manage the demanding nature of T1D. Given their own experiences parenting young children with T1D, parent coaches were in a unique position to offer support by sharing their experiences and offering practical tips during the adjustment period, such as how they handled seasonal events and special circumstances that deviate from the usual T1D daily management routine (e.g., birthday parties, holidays, vacation/travel). As lay interventionists, parent coaches in Step 1 did not teach cognitive or behavioral strategies explicitly, but they were trained to incorporate many CBT and Positive Psychology–based strategies into their contacts with parents, such as reinforcing parents for adaptive thinking, modeling positive reframing of diabetes-related challenges, recognizing participants’ capabilities and successes managing difficult situations, and giving examples of behavioral strategies for coping with diabetes-related challenges that they have found to be effective in their own experiences. Parent coaches also drew on concepts from SCT by offering social support and providing opportunities for observational learning by sharing personal experiences with their own young children with T1D. In First STEPS, parent coaches role-modeled coping behaviors and problem solving about disease management. Some shared specific tools that permitted parents to observe them manage their own child’s diabetes, including but not limited to letting parents see/view their diabetes technologies, sharing school educational modifications and plans, and sharing resources and “cheat sheets” the parent coaches themselves use to teach babysitters and grandparents about diabetes.
Parent coaches were recruited and enrolled based on family and parent characteristics. Potential parent coaches were identified by recommendations from medical providers and healthcare team members. Study staff interviewed potential parent coaches to assess interest and fit. Those eligible participated in a 4-hour parent coach training session that included education about their responsibilities for the study as well as activities in modeling active listening skills and practicing via interactive role-plays. Training emphasized the supportive role of the parent coach, taught them to reinforce parents’ strengths and successes, and instructed about the scope of their role (e.g., refrain from offering medical advice, how to handle emergencies). Parent coaches were provided with binders with example topics (e.g., sharing diabetes management responsibility with other caregivers, mealtimes). Pairings of coaches and participants were based on parent coach availability and family characteristics such as geographic location and child age at time of diagnosis. For ongoing education and support, parent coaches received monthly supervision from staff (more frequent when they were assigned a new family or as challenges arose) and they were invited to participate in annual refresher meetings. Individual supervision time also addressed helping parent coaches manage their own personal and family concerns while parent coaching. Parent coaches were given incentives for their time in training, when meeting in person with assigned participant, and following completion of their 9 months of contact with each parent. The details of the parent coach training protocol used are described by Tully et al (2017), which shows promising results regarding feasibility and acceptability.
Step 2
Step 2 included 5 telephone-based CBT-based sessions, one of which was a group session with other study participants who were also in Step 2. In Step 2, phone counselors taught specific CBT skills in a manualized treatment package, including practical problem-solving, goal-setting, parent management training, and cognitive restructuring. Positive Psychology components were included throughout the sessions, including an emphasis on identifying and reinforcing participant successes using the skills, teaching positive cognitive reframing skills, and a culminating activity around practicing gratitude. The sessions were designed to take 30–40 minutes each and were completed over the 12-week intervention window. The individual sessions were sequential and the group call was completed at any time after the first session. Telephone counselors with masters’ level education in psychology or social work delivered the sessions per a manualized intervention protocol for which they received training and ongoing supervision. Step 2 interventionists were trained using a structured sequential approach. All Step 2 interventionists were selected for having prior experience delivering behavioral interventions and/or familiarity with T1D. All interventionists were trained in general diabetes knowledge through a combination of educational experiences, such as reading patient education materials and shadowing diabetes care providers. Interventionists were also trained in behavioral interventions by reading diabetes behavioral research articles and cognitive-behavioral intervention manuals (e.g., Barkley, 2013; Gilson et al., 2009). Step 2 interventionists read the manual and attended a 2-hour training session (via video-conference) to learn about the content and goals of the treatment led by the study’s investigators. During the training, interventionists were instructed to find opportunities to reinforce participants and help connect them with local or national peer-support resources, in line with the intervention’s core SCT principles and emphasis on integrating Positive Psychology components. Interventionists practiced specific skills in small groups and received feedback.
Following the training, interventionists recorded a practice session with another staff member. The investigators created fidelity forms for each session, which assessed the degree to which each intervention component was completed (1 = did not cover/was not present to 3 = good delivery). Fidelity forms included 3–5 core skills for each session (e.g., introduce problem solving; teach cognitive restructuring) as well as four items designed to measure clinician delivery (e.g., facilitate parent’s engagement, be flexible/responsive). Interventionists were required to deliver ≥80% of the components before being permitted to deliver the session to participants. Psychologists at each site reviewed audio recordings and gave feedback. There was a mean 98% fidelity from the training recordings. For ongoing support, interventionists participated in monthly group supervision by site with a psychologist, as well as monthly group cross-site calibration calls led by a psychologist. Supervision sessions frequently included instrumental support for completing study procedures (e.g., troubleshooting audio recording system, reviewing where to access files, helping interventionists coordinate with study team at large), surveillance of participant progress through the intervention and problem-solving barriers, review of audio, sharing ideas about delivering the intervention, and referral options for families.
The cognitive behavioral skills (see Table 3) were provided for parents with the aim of instilling hope and self-efficacy regarding managing T1D in their young child. Skills were introduced and rehearsed in each session. Phone counselors were trained to use didactic methods to first introduce CBT skills, rehearse using a manualized example unrelated to diabetes management, and then rehearse skill using a personalized example relating to the parent’s diabetes management. For example, cognitive restructuring was presented by introducing the cognitive triad, using an example of a misunderstanding with a neighbor, and how changing their thoughts about the situation lead to different emotions and behaviors. Next, the counselor used a diabetes-related example from the parent’s life, or supplied the following situation if the participant did not generate a personalized example: “What if you were in this situation: your child was being watched by your partner or a relative for a Saturday afternoon while you get a rare afternoon to yourself to go to a movie with a friend. When you come home, you check your child’s blood glucose and discover he/she has a blood glucose level of 300. What might your thought be?” The counselor led participants through the cognitive restructuring, while emphasizing importance of shared caregiving and working as a team with others to manage the child’s diabetes.
Table 3.
Step 2 Phone Sessions
Session | Focus | Techniques/Strategies |
---|---|---|
1 | Adjusting to Life with Diabetes | • Psychoeducation about developmental stages and diabetes management • Problem solving • Mindful breathing |
2 | Glycemic Goals Working as a Team | • Assertive communication skills • Sharing diabetes caregiving tasks • Cognitive restructuring - fear of hypoglycemia as an example |
3 | Promoting Resilience and Positive Child Behavior | • Behavioral parenting principles: routines, selective attention, effective commands – mealtimes as an example. |
4 | Self-Care and Future Problem Prevention | • Behavioral activation • Gratitude • Review of previously learned skills with future challenges |
Group call | Family Management and Support | • Social support • Instrumental and emotional support |
Note. Step 2 sessions were delivered in 30–45 minute phone calls by a masters-level counselor.
Throughout Step 2, participants were encouraged to practice new skills between sessions to facilitate in vivo skill application and generalizability. Formal problem-solving steps were a core component of the intervention; problem solving was introduced in the first call and reviewed with parents’ own examples in each subsequent session. The manual included reminders for phone counselors to reinforce parents for using the skills and to build on family strengths in each session.
In line with SCT, the group call allowed participants to learn from observing each other. The goal of the call was for the parents to relate to one another, normalize each other’s experiences, and share tips and resources. The phone counselor facilitated introductions among the group call participants, and then posed at least three open-ended questions designed to stimulate discussion. For example, to integrate Positive Psychology, the phone counselor initiated a discussion on family strengths: “Every family has strengths in certain areas of diabetes management, but struggles with others. What are some areas you feel your family does well with? What are you still working on?” As each participant commented on the open-ended questions, the phone counselor moderated the discussion. Parent coaches (Step 1) continued to provide support to parents who also transitioned to Step 2.
Step 3
The most intensive level of the intervention, Step 3 was designed to offer personalized support related to both diabetes management and parental and child well-being, delivered by trained healthcare professionals with expertise in T1D care in young children. Step 3 consisted of individual meetings with a certified diabetes educator (CDE) and a licensed clinical psychologist (Ph.D.) with experience working clinically with families of youth with T1D. The CDE and psychologist specifically finds opportunities to increase the parent’s knowledge about the risks and benefits of health behaviors and tries to increase the family’s self-efficacy to attain these health benefits. The CDE and psychologist also help the family set goals and discuss changes in the family and/or social environment to make these goals more attainable. In line with the Positive Psychology framework, the CDEs and psychologists recognized and reinforced each parent’s successes with diabetes management and adjustment while conducting tailored assessment and providing individualized recommendations. There is an inherent conflict in the goal to standardize an individualized consultation, which is designed to be responsive to families’ unique set of challenges and strengths. The goal was to allow for “flexibility within fidelity” (Kendall et al., 2008) to encourage individualization of the content within the protocol of the intervention. Therefore, these interactions did not follow a strict script/manual, but the procedures were standardized such that all families were offered a blinded trial of continuous glucose monitoring (CGM) followed by a 1-hour appointment with a CDE for individualized glucose pattern feedback and recommendations based on the CGM data, and a 1-hour appointment with a clinical psychologist (each detailed below). During each appointment, the CDE and psychologist followed a semistructured outline of topics to address (e.g., assessing barriers to optimal glucose management, praising parents’ efforts). After each consultation, the CDE and psychologist each entered a brief note into the child’s electronic medical record to ensure the diabetes care team was aware of any recommendations made to their patients.
One goal of Step 3 was for a CDE to provide individualized feedback, education, and goal setting to the parent about the child’s glucose management using the child’s glucose trend data. For children using a personalized CGM, their data were downloaded for the CDE appointment. For children not using personal CGM, the CDE placed a blinded CGM on the child’s body in FDA-approved locations for 1 week and the parent kept detailed logs of all diabetes management behaviors, including insulin doses and times, food and carbohydrate intake, and physical activity. The CGM technology monitored and recorded the child’s glucose values every 5 minutes; blinded CGM was used instead of a device that allowed parents to see the near-real time glucose values because the goal was to help the CDE provide feedback on parents’ current diabetes management behaviors. Parental access to live CGM data, including alerts for out of range glucose values, carried a high risk of increasing parental stress for families who did not clinically seek it out and had the potential to change parents’ management behaviors; the blinded CGM technology allowed the CDE to observe typical glucose patterns and provide feedback to the parent. For parents who were not comfortable using the CGM device or were unable to attend in-person meetings with the CDE to place and remove the CGM, parents completed the insulin, activity, and food logs and additional blood glucose checks using glucometers to provide detailed information about the child’s glucose trends. The CDE reviewed these data in person or by telephone, based on parents’ scheduling requirements.
Step 3 included two meetings approximately 1 week apart with the CDE, each following a scripted outline. At the first meeting, for those families whose child was not using a personal CGM, the CDE placed the blinded CGM on the child’s body, provided brief education about using CGM, showed the parent how to complete the insulin, food, and activity logs, and instructed the parent not to change their usual diabetes management approach during the week. The CDE and parent decided on sensor placement location and used age-appropriate distraction methods for pain prevention/management (Birnie et al., 2018). At the second meeting, the CDE removed the sensor if the parent had not already done so, and downloaded the device. Based on review of the CGM data and logs, the CDE educated the parent about their child’s glucose variability, made recommendations for changes to insulin, food, or activity, and helped parents set realistic management goals. If regimen changes were indicated based on the CGM data and logs, the CDE reviewed recommendations with the treating medical team. If any parents were interested in using CGM for their child’s usual management (un-blinded), the CDE encouraged parents to discuss this with their medical provider(s).
The clinical psychologists who delivered the other part of Step 3 were already embedded within the diabetes teams at each site, and therefore were quite experienced working with children and families with T1D. For this study, they were trained to assess for child and parent diabetes-related distress and instructed to provide brief behavioral interventions and recommendations, with a focus on reinforcing what the parent/family was doing well related to diabetes management and adjustment. When relevant, they built upon cognitive and behavioral skills discussed during the Step 2 phone calls (e.g., problem solving, seeking social support, monitoring thoughts and emotions), and provided referrals for ongoing psychological/behavioral care if warranted. To ease travel and time burdens for the family, Step 3 consultations were offered in person, via phone, or via HIPAA-compliant telemedicine technology where parties can see and talk to one another through the computer. When possible, CDE and psychologist visits were scheduled on the same day. Prior to each participant’s engagement in Step 3, the Step 2 phone counselors shared a summary of their experiences from Step 2 calls with the psychologist to facilitate a sense of continuity for the participant. All participants enrolled in Step 3 continued with the parent coach (Step 1), who continued to provide role modeling and support.
Analytic Plan
Data from the four pilot participants are reported. Summary data from Step 1 include frequencies, means and standard deviations for amount of contact between pilot participants and their parent coaches. Process data are then presented from two pilot participants for the First STEPS intervention The data from two pilot participants, one who remained in Step 1 and one who progressed to Step 3, illustrate possible participant experiences in the First STEPS intervention. Data include medical outcomes (e.g., A1c), standardized psychosocial measures, process data (e.g., sessions attended, parent coach contacts, satisfaction ratings), and qualitative feedback collected via interviews with pilot participants, parent coaches, and study staff.
Results
Study activities from four participants with whom the intervention was piloted are summarized in this section; two of these pilot participants are further explored as case studies in the next session. Pilot participants were three mothers and one father (mean age = 37.25 years, SD = 2.05) of three female and one male children newly diagnosed with T1D (mean age = 2.25, SD = 0.43). All pilot participants received the intervention to examine acceptability and feasibility. In Step 1, all participants were assigned a parent coach. Participants had an average of 24.88 contacts (SD = 5.03) with their parent coaches over the 9-month intervention period; contacts were more frequent in beginning (M = 4.25 per month in the first 3 months, SD = 3.01) and less frequent in the remaining months 4–9 (M = 1.90/month, SD = 0.74). The decrease after 3 months is per the study guidelines for this step, but the overall frequency is higher than study guidelines recommended (i.e., 18 contacts total over the course of the study or 4 contacts/month in first 3 months, 1 contact/month in final 6 months). Three of the four pilot participants met in person with their parent coach; barriers for the one dyad that did not meet in person were wide geographical distance and misalignment of schedules. Pilot participants were in touch with their coaches via in-person meetings, phone calls, text, and email. Parent coaches completed 100% of their data collection reporting, and there was 100% participation in monthly supervision calls with study staff. Participants self-reported high levels of satisfaction with the intervention. The range of responses for all satisfaction surveys was 1 (strongly agree) to 3 (neutral); no participants reported answers of disagreeing (4) or strongly disagreeing (5) with any of the satisfaction statements. All four of the pilot participants reported high satisfaction with the program overall, with an average rating of 1.25, and high satisfaction with the parent coaches, with the average rating of 1.39. Notably, the average ratings to the questions, “My parent coach was a good listener and supportive” and “My parent coach shared helpful resources with me,” were both 1.25, with three participants stating strongly agree and one reporting agree for each. These were the core skills the parent coach training focused on. The two pilot participants who progressed to Steps 2 and 3 rated high satisfaction with each (Step 2 average rating 1.44, Step 3 average rating 1.65).
In interviews, parents also reported high satisfaction with the program and their participation (“It was all great, I liked it a lot.)” Positive comments about the program included that pilot participants appreciated the parent coaches and their ability to relate to the newly diagnosed experience, enjoyed interactions with study staff, enjoying the content and group call as part of Step 2, and the CGM and feedback component of Step 3. Two parents suggested shortening the assessment battery, and one parent commented that it was “felt slightly awkward” to terminate the relationship with her parent coach at the end of the study. She explained that knowing that the parent coach was available only for the duration of the study had prevented her from fully opening up to the coach. In response to this feedback, the study team revised the parent coach guidelines to permit parent coaches to remain in contact with their families after the study if they chose.
Two of the four pilot participants advanced to Step 2. Step 2 phone counselors self-reported 98% adherence to the study manual. These same two pilot cases proceeded to Step 3. One participant met with the clinical psychologist and CDE in person and one completed these appointments via telemedicine/phone. We summarize two of the pilot participants’ experiences as representative case examples to illustrate possible pathways through the stepped intervention1: one participant who progressed through all intervention steps, and one who stayed in Step 1. Both pilot participants completed participation in the intervention and all assessment time points. In each case, we discuss how the treatment was delivered as well as specific challenges and ways interventionists individualized the treatment. Table 4 reports the CES-D and A1c values for these two pilot participants. Of note, none of the four pilot cases had elevated CES-D scores at any of the measured time points.
Table 4.
Stepped Care Progress of Two Case Examples
Time Point | Pilot Case 1 | Pilot Case 2 | ||
---|---|---|---|---|
CES-D | A1c (%) | CES-D | A1c (%) | |
Baseline value | 2 | 9 | 0 | 9.2 |
Check-in 1 value | 1 | 6.1 | 0 | 9.2 |
Step decision | Remain in Step 1 | Move to Step 2 based on A1c | ||
Check-in 2 value | 2 | 5.3 | 0 | 8.7 |
Step decision | Remain in Step 1 | Move to Step 3 based on A1c | ||
Follow up 1 value | 3 | 7.4 | 1 | 8.5 |
Follow up 2 value | 9 | 8 | 0 | 8.9 |
Note. CES-D = Center for Epidemiological Studies – Depression.
Baseline parent CES-D data is collected within 4 weeks of their child’s diabetes diagnosis. Check-in 1 is approximately 3 months post-diagnosis, check in 2 is approximately 6 months after diagnosis, follow up 1 approximately 9 months after diagnosis, and follow up 2 approximately 15 months after diagnosis. CES-D goal was ≤ 16, and A1c goal was < 8.0%.
Case Examples
Case 1
One parent who remained in Step 1 throughout the study was a mother of a young participant. This mother established a supportive relationship with her parent coach, they met in-person and were in frequent contact by phone and text messaging. She took a solution-focused approach and sought diabetes management tips from her parent coach. She also described receiving a good deal of social support in her life.
Throughout the 9 months of the intervention phase of the study following diagnosis, her child stayed in the “honeymoon phase,” a period of time following a T1D diagnosis when blood glucose values remain near normal levels and very little exogenous insulin is required, which is common in young children (Abdul-Rasoul et al., 2006). Since the child’s honeymoon period was causing the participant to not experience some of the expected stressors related to a new diabetes diagnosis, parent-coach contact was adapted for more of an anticipatory and preventive approach. The parent coach generated potential challenges proactively and reframed the content as preparing for possible scenarios that may arise in the future when the honeymoon phase ends. For example, the coach was encouraged to share practical tips for diabetes management at parties, on vacation, while swimming or playing sports, and starting school or childcare. The coach also encouraged the participant to practice enlisting help from other caregivers for minor needs, in preparation for later being comfortable asking for help with larger diabetes-related needs that could arise. Study staff worked closely with the parent coach to ensure the successful adaptation of intervention material into more of an educational, prevention approach. The parent was especially interested in learning about continuous glucose monitoring systems and inquired about how the parent coach used it with her own child. Additionally, the parent coach encouraged the parent to explore websites, online support groups, and local parent groups. The family experienced an emergency situation relating to a natural disaster and the parent coach assisted with problem solving ways to establish and maintain diabetes management routines while living in temporary housing. At the check-in visits, this parent did not advance to Step 2 based on depressive symptoms or the child’s A1c, so she remained in Step 1 only throughout the full 9-month intervention period.
After the intervention was complete, the parent gave the highest satisfaction ratings on the acceptability questionnaire. She stated she strongly agreed with the statement, “Overall, I am glad I participated in the study.” The participant’s only critique was that some of the psychosocial assessments had items that she did not feel applied to her child’s age. On the satisfaction questionnaires, this parent wrote about the study, “I think it’s great, although … I feel we have not fully experienced diabetes yet.” About her parent coach, she wrote, “She was the first person that I met that I felt understood what we were going through. She was very helpful in every way.” Both the parent coach and parent expressed that they planned to stay in touch after study completion as they had developed a friendship.
Case 2
One parent who participated in all three steps of the intervention was a father of a young child. He and his family advanced through the three intervention steps as his child’s A1c was >8.0% at each study visit. His responses on the CES-D indicated no elevated depressive symptomatology throughout the study. At the time he moved to Step 3, his child had been diagnosed with T1D for 6 months. He expressed interest in starting diabetes technologies, including CGM.
In Step 1, this participant was paired with a parent coach who was a father. He and his parent coach met once in person, spoke by phone approximately once every 2 weeks, and exchanged numerous text and email conversations. His parent coach reported that many of their contacts focused on diabetes management using technology, diet, and normalizing stress relating to diabetes management. At 3-month follow-up assessment, the participant moved up to Step 2, again due to his child’s A1c above target. In Step 2, he was engaged with his phone counselor and participated by giving personal examples of each skill. However, this participant reported different needs for the skills delivered in Step 2: he reported that he used the problem-solving steps frequently and that they were helpful, but he reported little emotional distress and few uses for the coping and stress management skills. The phone counselor adapted the treatment in three ways: (1) boosting self-efficacy by providing opportunities for the parent to discuss methods they use to cope well with emotional stress and praise for use of these methods; (2) building insight into how other family members were coping with adjustment to diabetes; (3) applying the skills toward the future.
When the parent moved to Step 3 at the 6-month follow-up assessment due to elevated A1c, the child wore a blinded CGM for 7 days during which the family kept a logbook of diet, carbohydrate counts, blood glucose levels, activities, and amount of insulin given. The CDE identified patterns of lows and highs after meals, which the parents treated by providing more insulin before the next meal. There was also a pattern of blood glucose dropping overnight. The CDE made recommendations to reduce the amount of carbohydrates given to treat lows, instructions on a basal/bolus regimen, and altering carbohydrate to insulin dosing ratio. In addition, he continued contact with his parent coach in Steps 2 and 3.
As part of Step 3, the pilot participant met with the diabetes team’s licensed clinical psychologist for a 35-minute consultation after meeting with the CDE. During this consultation, he first acknowledged how informative the CGM trial was in giving him a clearer understanding of both the benefits and drawbacks of CGM use for his child/family, as he had previously been eager to start a CGM. He noted that the family generally communicated openly and clearly to ensure that his child ate healthy foods, engaged in physical activities, and continued to participate in the activities she has always enjoyed. He reported that they overcame minor behavioral challenges (e.g., whining, requesting one parent perform a diabetes task) by remaining consistent and matter-of-fact, which had been reinforced during the Step 2 phone calls. Drawing upon Positive Psychology principles, the psychologist praised these effective approaches and encouraged continued use, consistent with the approach taken in Step 2. The psychologist and the participant discussed the family’s adjustment to T1D, challenges that had arisen since diagnosis, and upcoming events that would require additional preparation and planning due to T1D (specifically, upcoming travel and the start of preschool). The psychologist normalized these stressors and provided resources (verbally and with a follow-up email including websites and attachments for future use) regarding flying/travel with T1D, websites for locating childcare providers, and local resources related to the T1D community. Additional mental health referrals and follow-up were not indicated, and the family was given direct contact information for the psychologist should they have questions or desire services in the future.
After the intervention was completed, this parent selected the highest satisfaction level on the acceptability questionnaire, stating that he strongly agreed with the item “Overall I am glad I participated in the study.” When asked how the study could improve, the only change he recommended was shortening the psychosocial outcomes assessment battery. He stated that he “really enjoyed” contact with his parent coach, and he attributed this to their similar solution-focused problem-solving approaches. He also stated that he appreciated being matched with a father as a parent coach, though he thought that matching on worldviews and coping styles might be even more important than gender. He stated that his parent coach was useful “to bounce ideas off of and just talk to him about his experiences.” Despite not reporting elevated psychosocial distress on standardized measures, he reported that the content in Step 2 was valuable. He stated that he enjoyed problem solving as an active coping method and found discussions about shared caregiving helpful. With regard to Step 3, he stated that receiving feedback on his child’s blood glucose variability and nutritional feedback from the CDE was “very valuable.” He reportedly made several changes to his child’s diabetes management following the visit. After getting more experience with CGM and discussing the pros and cons with the psychologist in Step 3, the family decided not to pursue a personal CGM device until his child was older.
Discussion
The aims of this paper were to describe the details of implementing our stepped-care behavioral First STEPS intervention for parents of young children newly diagnosed with T1D and to present the initial evidence of feasibility and acceptability. The stepped-care intervention progresses through three increasing levels of intensity, including parent coaches, phone sessions with trained counselors, and family consultations for assessment and recommendations with a licensed diabetes psychologist and a certified diabetes educator. We used evidence-based cognitive behavioral strategies and emphasized social-cognitive intervention targets throughout each step of the stepped-care model’s multitiered approach.
We reported on the experiences of two pilot participants to illustrate representative participant experiences in the First STEPS project. The pilot participants saw some improvements in A1c throughout the intervention; depressive symptoms were not significant for either. Though indicators of diabetes health (A1c) worsened for one during follow-up assessment time points, it is possible this is related to the end of the honeymoon phase. Each pilot participant described limitations of the psychosocial outcome assessment battery, but otherwise reported universally high satisfaction with the intervention. Overall, the results provide good initial evidence of the feasibility and acceptability of the newly developed First STEPS intervention for parents of newly diagnosed young children with T1D.
Clinical implications from this work include the potential benefits of screening parents at the time of diagnosis for psychological distress and over the subsequent year. The feasibility data from our work with the pilot cases suggests that peer mentorship is likely to be very meaningful and appreciated by families in the first year after a diabetes diagnosis. In our pilot participants, personalization of the intervention content was required to meet the unique needs of each family; the combination of CBT and Positive Psychology strategies allowed interventionists to make minor adjustments to the intervention’s tone/focus as needed for each participant, while remaining within the structure of the protocol and aligned with the SCT foundation of the study.
This study has some limitations that need to be considered. This paper focused on the clinical considerations and preliminary feasibility of the intervention being studied in the trial, and therefore cases were used to more fully describe the intervention. Data are not yet available about the efficacy of this intervention compared to usual care. Further, none of the pilot cases demonstrated elevated depression ratings at any of the measured time points. Depression was included as an important target as the literature demonstrates the association between depressive symptoms and poor health behaviors across a range of chronic disease (Grenard et al., 2011), and specifically within pediatric T1D samples (McGrady & Hood, 2010). Therefore, additional research is needed to understand the feasibility and acceptability of First STEPS for parents in more distress.
First STEPS is a promising stepped-care treatment model for supporting parent psychosocial stress and improving child glycemic outcomes in the first year following young child diagnosis with T1D. Results indicated that the treatment and delivery model were acceptable to the pilot participants, as evidenced by treatment completion and satisfaction ratings. Further, the treatment demonstrated feasibility in that phone counselors were able to be trained in, and effectively administer, the treatment protocol. Future directions for this work include testing the efficacy of this new treatment in a randomized controlled trial, which will provide data that will further contribute to the CBT treatment evidence base in pediatric psychology.
Highlights.
Though parenting a young child newly diagnosed with type 1 diabetes (T1D) is stressful, there are currently no interventions to help promote psychological health and health for families with young children with T1D.
First STEPS is a promising stepped-care treatment for supporting parent psychosocial stress and improving child glycemic outcomes in the first year following young child diagnosis with T1D.
Results indicated that the treatment and delivery model were acceptable to two pilot participants, who are described as case studies.
Acknowledgments
This research was supported by grant RO1DK102561 from the National Institute of Diabetes and Digestive and Kidney Diseases (last author PI). The authors thank the families who participated in the development of the First STEPS program, with special thanks to the two pilot participants who provided permission to be included as case studies in this manuscript.
Footnotes
Pilot participants gave their permission to be included in this manuscript.
The authors declare no conflicts of interest.
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Contributor Information
Carrie Tully, Children’s National Health System and George Washington University.
Lauren Clary, Children’s National Health System and George Washington University.
Maureen Monaghan, Children’s National Health System and George Washington University.
Wendy Levy, Texas Children’s Hospital and Baylor College of Medicine.
Marisa E. Hilliard, Texas Children’s Hospital and Baylor College of Medicine
Randi Streisand, Children’s National Health System and George Washington University.
References
- Abdul-Rasoul M, Habib H, & Al-Khouly M (2006). ‘The honeymoon phase’ in children with type 1 diabetes mellitus: frequency, duration, and influential factors. Pediatric Diabetes, 7(2), 101–107. 10.1111/j.1399-543X.2006.00155.x [DOI] [PubMed] [Google Scholar]
- American Diabetes Association. (2013). Standards of medical care in diabetes. Diabetes care, 36(Suppl 1), S11. 10.2337/cd17-0119 [DOI] [PMC free article] [PubMed] [Google Scholar]
- American Diabetes Association. (2017). Standards of medical care in diabetes. Diabetes care, 40(Suppl 1), S1–S135. 10.2337/cd16-0067. [DOI] [PubMed] [Google Scholar]
- American Diabetes Association. (2020). 13. Children and adolescents. Diabetes Care, 43(Supplement 1), S163–S182. 10.2337/dc20-S013 [DOI] [PubMed] [Google Scholar]
- Bandura A, & National Institute of Mental Health. (1986). Prentice-Hall series in social learning theory. Social foundations of thought and action: A social cognitive theory. Prentice-Hall, Inc. [Google Scholar]
- Bandura A (2004). Health promotion by social cognitive means. Health Education and Behavior, 31(2), 143–164. 10.1177/1090198104263660 [DOI] [PubMed] [Google Scholar]
- Barkley RA (2013). Defiant children: Third Edition: A clinician’s manual for assessment and training. New York, NY: Guilford Press. [Google Scholar]
- Baranowski T, Perry CL, Parcel GS (2002). How Individuals, Environments, and Health Behavior Interact. In Glanz K, Rimer BK, Lewis FM, (Eds.), Health Behavior and Health Education: Theory, Research, and Practice. (pp. 165–184). Jossey-Bass. [Google Scholar]
- Barzel M, & Reid GJ (2008). Diabetes-Specific Coparenting Questionnaire (DCQ). Unpublished instrument, University of Western Ontario, Ontario, Canada. [Google Scholar]
- Birnie KA, Noel M, Chambers CT, Uman LS, & Parker JA (2018). Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database of Systematic Reviews, (10). 10.1002/14651858.CD005179.pub4 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Bowes S, Lowes L, Warner J, & Gregory JW (2009). Chronic sorrow in parents of children with type 1 diabetes. Journal of Advanced Nursing, 65(5), 992–1000. 10.1111/j.1365-2648.2009.04963.x [DOI] [PubMed] [Google Scholar]
- Bower P, & Gilbody S (2005). Stepped care in psychological therapies: access, effectiveness and efficiency: narrative literature review. The British Journal of Psychiatry, 186(1), 11–17. 10.1192/bjp.186.1.11 [DOI] [PubMed] [Google Scholar]
- Buysse DJ, Reynolds CF, Monk TH, Burman SR, & Kupfer DJ (1989). The Pittsburgh sleep quality index: A new instrument for psychiatric practice and research. Psychiatry Research, 28(2), 193–213. 10.1016/0165-1781(89)90047-4 [DOI] [PubMed] [Google Scholar]
- Cathey M & Gaylord N (2004). Picky eating: A toddler’s continuing approach to mealtime. Pediatric Nursing, 30(2), 101–107. Retrieved from http://www.pediatricnursing.net [PubMed] [Google Scholar]
- Chiang JL, Kirkman MS, Laffel LM, & Peters AL (2014). Type 1 diabetes through the life span: a position statement of the American Diabetes Association. Diabetes care, 37(7), 2034–2054. 10.2337/dc14-1140 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Cohen S, Kamarch T, & Mermelstein R (1983). A global measure of perceived stress. Journal of Health and Social Behavior, 24, 385–396. doi: 10.2307/2136404 [DOI] [PubMed] [Google Scholar]
- Counts JM, Buffington ES, Chang-Rios K, Rasmussen HN, & Preacher KJ (2010). The development and validation of the protective factors survey: A self-report measure of protective factors against child maltreatment. Child abuse & neglect, 34(10), 762–772. [DOI] [PubMed] [Google Scholar]
- Cox DJ, Irvine A, Gonder-Frederick L, Nowacek G,, Butterfield J (1987). Fear of hypoglycemia: Quantification, validation, and utilization. Diabetes Care, 10. 617–621. 10.2337/diacare.10.5.617 [DOI] [PubMed] [Google Scholar]
- Crist W & Napier-Phillips A (2001). Mealtime behaviors of young children: A comparison of normative and clinical data. Developmental and Behavioral Pediatrics, 22, 279–286. [DOI] [PubMed] [Google Scholar]
- Dabelea D, Bell RA, D’Agostino JR, Imperatore G, Johansen JM, Linder B, … Pettitt DJ (2007). Incidence of diabetes in youth in the United States. JAMA, 297(24), 2716–2724. doi: 10.1001/jama.297.24.2716 [DOI] [PubMed] [Google Scholar]
- Dabelea D, Mayer-Davis EJ, Saydah S, Imperatore G, Linder B, Divers J, … Liese AD (2014). Prevalence of type 1 and type 2 diabetes among children and adolescents from 2001 to 2009. JAMA, 311(17), 1778–1786. doi: 10.1001/jama.2014.3201 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Driscoll KA, Raymond J, Naranjo D, & Patton SR (2016). Fear of hypoglycemia in children and adolescents and their parents with type 1 diabetes. Current Diabetes Reports, 16(8), 77. 10.1007/s11892-016-0762-2 [DOI] [PMC free article] [PubMed] [Google Scholar]
- D’Zurilla TJ, Nezu AM, & Maydeu-Olivares A (2002). Social problem-solving inventory—revised (SPSI-R). Multi-Health Systems. [Google Scholar]
- Gilson M, Freeman A, Yates MJ, & Freeman SM (2009). Overcoming depression: Second edition. Oxford University Press. [Google Scholar]
- Goonetilleke R, Pollitzer M, & Mann N (2004). Insulin for toddlers with difficult diabetes. Diabetes Care, 27(6), 1505. 10.2337/diacare.27.6.1505. [DOI] [PubMed] [Google Scholar]
- Grenard JL, Munjas BA, Adams JL, Suttorp M, Maglione M, McGlynn EA, & Gellad WF (2011). Depression and medication adherence in the treatment of chronic diseases in the United States: A meta-analysis. Journal of General Internal Medicine, 26(10), 1175–1182. 10.1007/s11606-011-1704-y. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Grossman H, Brink S, & Hauser S (1987). Self-efficacy in adolescent girls and boys with insulin-dependent diabetes mellitus. Diabetes Care, 10(3), 324–329. 10.2337/diacare.10.3.324 [DOI] [PubMed] [Google Scholar]
- Haaga DAF (2000). Introduction to the special section on stepped care models in psychotherapy. Journal of Consulting and Clinical Psychology, 68(4), 547–548. 10.1037/0022-006X.68.4.547 [DOI] [PubMed] [Google Scholar]
- Hilliard ME, Monaghan M, Cogen FR, & Streisand R (2011). Parent stress and child behaviour among young children with type 1 diabetes. Child: care, health and development, 37(2), 224–232. 10.1111/j.1365-2214.2010.01162.x [DOI] [PubMed] [Google Scholar]
- Hilliard ME, Tully C, Monaghan M, Wang J, & Streisand R (2017). Design and development of a stepped-care behavioral intervention to support parents of young children newly diagnosed with type 1 diabetes. Contemporary Clinical Trials, 62. 10.1016/j.cct.2017.08.009 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Hood KK, Rohan JM, Peterson CM, & Drotar D (2010). Interventions with adherence-promoting components in pediatric type 1 diabetes. Diabetes Care, 33(7), 1658–1664. 10.2337/dc09-2268 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Irwin DE, Stucky B, Langer MM, Thissen D, DeWitt EM, Lai J… and DeWalt DA (2010). An item response analysis of the pediatric PROMIS anxiety and depressive symptoms scales. Quality Life Research, 19(4), 595–607. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Kazak A (2006). Pediatric Psychosocial Preventative Health Model (PPPHM): Research, practice, and collaboration in pediatric family systems medicine. Families, Systems, and Health, 24(4), 381–395. 10.1037/1091-7527.24.4.381 [DOI] [Google Scholar]
- Kendall PC, Gosch E, Furr JM, Sood E (2008). Flexibility within fidelity. Journal of the American Academy of Child and Adolescent Psychiatry, 47(9), 987–93. 10.1097/CHI.ObO13e31817eed2f [DOI] [PubMed] [Google Scholar]
- Kovacs M, Iyengar S, Goldston D, Obrosky DS, Stewart J, & Marsh J (1990). Psychological functioning among mothers of children with insulin dependent diabetes mellitus: a longitudinal study. Journal of Consulting and Clinical Psychology, 58(2), 189. 10.1037/0022-006X.58.2.189 [DOI] [PubMed] [Google Scholar]
- Lee E (2012). Review of the psychometric evidence of the Perceived Stress Scale. Asian Nursing Research, 6, 121–127. 10.1016/j.anr.2012.08.004 [DOI] [PubMed] [Google Scholar]
- Lewin AB, Storch EA, Silverstein JH, Baumeister AL, Strawser MS & Geffken GR (2005). Validation of the Pediatric Inventory for Parents in mothers of children with type 1 diabetes: An examination of parenting stress, anxiety, and childhood psychopathology. Family, Systems & Health, (23), 56–65. [Google Scholar]
- Lowes L, Lyne P, & Gregory JW (2004). Childhood diabetes: parents’ experience of home management and the first year following diagnosis. Diabetic Medicine, 21(6), 531–538. 10.1111/j.1464-5491.2004.01193.x [DOI] [PubMed] [Google Scholar]
- Macaskill A (2016). Review of positive psychology applications in clinical medical populations. Healthcare (4)3, 66. 10.3390/healthcare4030066. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Mackey ER, Herbert L, Monaghan M, Cogen F, Wang J, & Streisand R (2016). The feasibility of a pilot intervention for parents of young children newly diagnosed with type 1 diabetes. Clinical Practice in Pediatric Psychology, 4(1), 35–50. 10.1037/cpp0000123 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Mayer-Davis EJ, Lawrence JM, Dabelea D, Divers J, Isom S, Dolan L, … Pihoker C (2017). Incidence trends of type 1 and type 2 diabetes among youths, 2002–2012. New England Journal of Medicine, 376(15), 1419–1429. https://doi.org10.1056/NEJMoa1610187 [DOI] [PMC free article] [PubMed] [Google Scholar]
- McAlister AL, Perry CL, & Parcel GS (2008). How individuals, environments, and health behaviors interact: Social cognitive theory. In Glanz K, Rimer BK, & Viswanath K (Eds.), Health behavior and health education: Theory, research, and practice (pp. 169–188). Jossey-Bass. [Google Scholar]
- McGrady ME & Hood KK (2010). Depressive symptoms in adolescents with type 1 diabetes: Associations with longitudinal outcomes. Diabetes Research and Clinical Practice, 88(3), e35–e37. 10.1016/j.diabres.2010.03.025. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Mitchell SJ, Hilliard ME, Mednick L, Henderson C, Cogen FR, & Streisand R (2009). Stress among fathers of young children with type 1 diabetes. Families, Systems, & Health, 27(4), 314. 10.1037/a0018191 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Miller KM, Foster NC, Beck RW, Bergenstal RM, DuBose SN, DiMeglio LA, … & Tamborlane WV (2015). Current state of type 1 diabetes treatment in the US: updated data from the T1D Exchange clinic registry. Diabetes Care, 38(6), 971–978. 10.2337/dc15-0078 [DOI] [PubMed] [Google Scholar]
- Monaghan M, Hilliard ME, Cogen FR, & Streisand R (2011). Supporting parents of very young children with type 1 diabetes: results from a pilot study. Patient Education and Counseling, 82(2), 271–274. 10.1016/j.pec.2010.04.007 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Mullins LL, Fuemmeler BF, Hoff A, Chaney JM, Van Pelt J, & Ewing CA (2004). The relationship of parental overprotection and perceived child vulnerability to depressive symptomotology in children with type 1 diabetes mellitus: The moderating influence of parenting stress. Children’s Health Care, 33(1), 21–34. 10.1207/s15326888chc3301_2 [DOI] [Google Scholar]
- Murphy HR, Rayman G, & Skinner TC (2006). Psycho-educational interventions for children and young people with Type 1 diabetes. Diabetic Medicine, 23(9), 935–943. 10.1111/j.1464-5491.2006.01816.x [DOI] [PubMed] [Google Scholar]
- Patton SR, Dolan LM, Henry R, & Powers SW (2008). Fear of hypoglycemia in parents of young children with type 1 diabetes mellitus. Journal of Clinical Psychology in Medical Settings, 15(3), 252–259. 10.1007/s10880-008-9123-x [DOI] [PMC free article] [PubMed] [Google Scholar]
- Patterson CC, Dahlquist GG, Gyürüs E, Green A, Soltész G, & EURODIAB Study Group. (2009). Incidence trends for childhood type 1 diabetes in Europe during 1989–2003 and predicted new cases 2005–20: a multicentre prospective registration study. The Lancet, 373(9680), 2027–2033. 10.1016/S0140-6736(09)60568- [DOI] [PubMed] [Google Scholar]
- Quinn M, Fleischman A, Rosner B, Nigrin DJ, & Wolfsdorf JI (2006). Characteristics at diagnosis of type 1 diabetes in children younger than 6 years. Journal of Pediatrics, 148(3), 366–371. 10.1016/j.jpeds.2005.10.029 [DOI] [PubMed] [Google Scholar]
- Radloff LS (1977). The CES-D scale: A self-report depression scale for research in the general population. Applied psychological measurement, 1(3), 385–401. 10.1177/014662167700100306 [DOI] [Google Scholar]
- Richards DA, Bower P, Pagel C, Weaver A, Utley M, Cape J, … Owens L (2012). Delivering stepped care: an analysis of implementation in routine practice. Implementation Science, 7(1), 3. 10.1186/1748-5908-7-3 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Schwartz DD, Cline VD, Axelrad ME, & Anderson BJ (2011). Feasibility, acceptability, and predictive validity of a psychosocial screening program for children and youth newly diagnosed with type 1 diabetes. Diabetes Care, DC_101553. 10.2337/dc10-1553 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Streisand R, Braniecki S, Tercyak KP, & Kazak AE (2001). Childhood illness-related parenting stress: The pediatric inventory for parents. Journal of Pediatric Psychology, 26(3), 155–162. [DOI] [PubMed] [Google Scholar]
- Streisand R, Mackey ER, Elliot BM, Mednick L, Slaughter IM, Turek J, & Austin A (2008). Parental anxiety and depression associated with caring for a child newly diagnosed with type 1 diabetes: Opportunities for education and counseling. Patient Education and Counseling, 73(2), 333–338. 10.1016/j.pec.2008.06.014 [DOI] [PubMed] [Google Scholar]
- Streisand R, & Monaghan M (2014). Young children with type 1 diabetes: Challenges, research, and future directions. Current Diabetes Reports, 14(9), 520. 10.1007/s11892-014-0520-2 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Streisand R, Swift E, Wickmark T, Chen R, & Holmes CS (2005). Pediatric parenting stress among parents of children with type 1 diabetes: The role of self-efficacy, responsibility, and fear. Journal of Pediatric Psychology, 30(6), 513–521. 10.1093/jpepsy/jsi076 [DOI] [PubMed] [Google Scholar]
- Sullivan-Bolyai S, Deatrick J, Gruppuso P, Tamborlane W, & Grey M (2002). Mothers’ experiences raising young children with type 1 diabetes. Journal for Specialists in Pediatric Nursing, 7(3), 93–103. 10.1111/j.1744-6155.2002.tb00158.x [DOI] [PubMed] [Google Scholar]
- Sullivan-Bolyai S, Deatrick J, Gruppuso P, Tamborlane W, & Grey M (2003). Constant vigilance: Mothers’ work parenting young children with type 1 diabetes. Journal of Pediatric Nursing, 18(1), 21–29. 10.1053/jpdn.2003.4 [DOI] [PubMed] [Google Scholar]
- Sullivan-Bolyai S, Grey M, Deatrick J, Gruppuso P, Giraitis P, & Tamborlane W (2004). Helping other mothers effectively work at raising young children with type 1 diabetes. The Diabetes Educator, 30(3), 476–484. 10.1177/014572170403000319 [DOI] [PubMed] [Google Scholar]
- Sullivan-Bolyai S, Bova C, Leung K, Trudeau A, Lee M, & Gruppuso P (2010). Social Support to Empower Parents (STEP). The Diabetes Educator, 36(1), 88–97. 10.1177/0145721709352384 [DOI] [PubMed] [Google Scholar]
- Tully C, Shneider C, Monaghan M, Hilliard ME, & Streisand R (2017). Peer coaching interventions for parents of children with type 1 diabetes. Current Diabetes Reports, 17(6), 39. 10.1007/s11892-017-0870-7 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Vandagriff JL, Marrero DG, Ingersoll GM, & Fineberg NS (1992). Parents of children with diabetes: what are they worried about? Diabetes Educator, 18(4), 299–302. 10.1177/014572179201800407 [DOI] [PubMed] [Google Scholar]
- Van Name MA, Hilliard ME, Boyle CT, Miller KM, DeSalvo DJ, Anderson BJ, … Tamborlane WV (2018). Nighttime is the worst time: Parental fear of hypoglycemia in young children with type 1 diabetes. Pediatric Diabetes, 19(1), 114–120. 10.1111/pedi.12525 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Van Name MA, Miller KM, Commissariat PV, Whitehouse AL, Harrington KR, Anderson BJ, Mantravadi MG, Levy W, DeSalvo DJ, Tamborlane WV, Hilliard ME, Laffel LM, & DiMeglio LA (2019). Greater parental comfort with lower glucose targets in young children with type 1 diabetes using continuous glucose monitoring. Diabetic Medicine, 36(11), 1508–1510. 10.1111/dme.14074 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Vehik K, Hamman RF, Lezotte D, Norris JM, Klingensmith G, Bloch C, … Dabelea D (2007). Increasing incidence of type 1 diabetes in 0-to 17-year-old Colorado youth. Diabetes Care, 30(3), 503–509. 10.2337/dc06-1837 [DOI] [PubMed] [Google Scholar]
- Whittemore R, Jaser S, Chao A, Jang M, & Grey M (2012). Psychological experience of parents of children with type 1 diabetes: a systematic mixed-studies review. The Diabetes Educator, 38(4), 562–579. 10.1177/0145721712445216 [DOI] [PMC free article] [PubMed] [Google Scholar]
- Wood JR, Miller KM, Maahs DM, Beck RW, DiMeglio LA, Libman IM, … T1D Exchange Clinic Network. (2013). Most youth with type 1 diabetes in the T1D Exchange Clinic Registry do not meet American Diabetes Association or International Society for Pediatric and Adolescent Diabetes clinical guidelines. Diabetes Care, 36(7), 2035–2037. 10.2337/dc12-1959 [DOI] [PMC free article] [PubMed] [Google Scholar]