Peer-support intervention for African American and Latino parents to improve the glycemic control trajectory among school-aged children with type 1 diabetes: A pilot and feasibility protocol

Abstract

Background

Type 1 diabetes (T1D) is a common, chronic pediatric health condition with complicated management demands. African American and Latino children with T1D have troubling disparities in glycemic outcomes and acute complications. While there are empirically supported behavioral interventions to support disease management in youth with T1D, there are few that specifically aim to reduce health disparities in this population. While collaborative parent involvement with the child with T1D management tasks is important to promote optimal glycemic outcomes during childhood, our formative research identified multiple individual, family, and broader system factors that impede or facilitate collaborative parental involvement among African American and Latino parents of children with T1D.

Methods

This paper describes the development, design, and study protocol for the Type 1 Diabetes Empowerment And Management (TEAM) pilot trial. The TEAM intervention is a novel, group-based behavioral intervention designed to enhance collaborative involvement in T1D management for African American and Latino parents of children aged 5–10. This randomized pilot trial’s primary aim is to evaluate the TEAM intervention’s feasibility and acceptability. The secondary aim is to examine preliminary intervention outcomes (i.e., children’s HbA1c, treatment adherence, collaborative parent involvement in T1D management, parent/child quality of life, and parent’s diabetes-related distress, depressive symptoms, and self-efficacy) compared to usual T1D care.

Discussion

The trial will provide preliminary information about whether optimizing appropriate parent involvement during the school-age years may increase T1D treatment adherence and stabilize or improve glycemic control in African American and Latino school-aged children.

1. Introduction

Type 1 diabetes (T1D) is one of the most common chronic conditions of childhood. [1] Maintaining healthy blood glucose levels prevents long-term complications of diabetes such as blindness, kidney failure, cardiovascular disease, and stroke. [2,3] To maintain healthy levels, the treatment regimen for T1D involves a complex set of self-care tasks that include monitoring blood glucose levels and administration of insulin multiple times each day, as well as paying particular attention to nutrition and physical activity. [4] Challenges in this treatment regimen contribute to morbidity and mortality from diabetes. [5,6]

African American and Latino youth are the largest racial/ethnic minority groups with T1D in the United States. [7] Increases in T1D incidence are steeper among these groups compared to non-Latino White youth. [8] In addition, African American and Latino youth experience pervasive disparities in diabetes health outcomes that persist throughout childhood [9–11], including higher rates of diabetic ketoacidosis and hypoglycemia compared to non-Hispanic white youth. [11,12] Together, these steeper increases in T1D incidence and disparate diabetes outcomes underscore the need for strategies to promote optimal health among African American and Latino youth.

Changing family behaviors related to sustaining developmentally appropriate parental involvement in diabetes management bolsters successful diabetes management and increases the likelihood of having optimal hemoglobin A1c (HbA1c), which is a measure of average blood glucose over the past 3 months. [13,14] To date, successful family behavioral programs that aim to promote developmentally appropriate parental involvement in diabetes management have been almost exclusively developed and evaluated among non-Hispanic white families. Yet, racial/ethnic differences in parental encouragement of children’s independent behavior supports the need to develop and evaluate interventions that are tailored for African American and Latino families. [15,16]. Indeed, no study has evaluated a family behavioral intervention focused on parental involvement and family diabetes management among Latino youth. In the few studies that focus on African American youth, interventions were delivered to adolescents who are already experiencing acute or chronic diabetes complications. [17,18] Developing and evaluating interventions for younger African American and Latino school-aged children to prevent significant glycemic control deterioration and disparities in complications in adolescence may more effectively decrease diabetes health disparities, given that chronically elevated HbA1c during the school-aged period increases the risk of poor brain development [19], quality of life [20], and diabetes complications [21] as children age. Developing a prevention-focused behavioral diabetes intervention tailored to families with younger African American and Latino children is likely to strengthen diabetes management and prevent poor glycemic control. For these reasons, our group of academic clinician researchers initiated a community-engaged research study to address family-management of T1D among African American and Latino families who sought medical treatment at an urban pediatric tertiary care hospital that serves a racially and ethnically diverse population.

2. Methods

2.1. Overall study design

This pilot study involved (1) a design phase and (2) a pilot phase. Both phases used a community engaged approach. We implemented a medium-intensity community-engaged approach, which is defined as a researcher-designed study with defined stakeholder roles. [22] Stakeholder engagement is expected to improve study design and recruitment and retention approaches for groups with more disease burden but are underrepresented in research. [23] The first phase (design) used a community engaged approach to adapt and modify the intervention protocol for Family Teamwork [13], an evidence-based behavioral intervention for families of adolescents with T1D, to meet the specific needs of African American and Latino parents of school-aged children. The first phase is complete. The second phase (pilot) used a pilot randomized design to evaluate the adapted intervention protocol’s feasibility and participant satisfaction. The secondary aim of the pilot phase was to explore preliminary intervention impact on behavioral, psychosocial, and glycemic outcomes, compared to usual care. Data collection for the second phase is complete, and data analysis is ongoing (ClinicalTrials.gov Identifier: NCT04053504).

2.2. PHASE 1 (intervention modification and adaptation and study protocol development)

The goals of the design phase were to (1) adapt and modify the Family Teamwork [13,24] intervention and (2) develop the study design and protocol.

First, we collaborated with a communications firm to determine how to reach, recruit, exchange information with, and deliver our intervention to African American and Hispanic families. In this step, Ford Momentum! (a communications consultant firm embedded in the community surrounding the hospital where this work took place) helped our research team use “message mapping” to take into account the target population’s values and develop a study name, mission, and color scheme that reflected the study’s goals and priorities and demonstrated respect for participating families. [22] A professional graphic designer created a study logo that captured these values, which we printed on recruitment, intervention, and retention materials. See Fig. 1 for the results of this process.

Fig. 1.

Message mapping deliverables and study logo.

Second, we adapted the Family Teamwork behavioral intervention content and design to be developmentally and culturally relevant. The Family Teamwork intervention is a clinic-based face-to-face intervention for adolescent youth with T1D and their parents. The 8-session program was delivered to adolescents and a parent every 3–4 months during routine clinic visits by a trained research assistant. Family Teamwork was specifically designed to increase positive parent involvement in, and reduce family conflict around, T1D management in adolescents with T1D. We modified an existing, evidence-based behavioral family intervention [13,24] because of its established efficacy in improving T1D treatment adherence and glycemic outcomes in adolescents. We sought to adapt the Family Teamwork intervention format, content and mode of delivery to be (1) culturally appropriate for African American and Hispanic families and (2) developmentally appropriate for elementary school-aged children. We also integrated intervention components—specifically, parenting intervention strategies and a group-based, peer-led delivery format that has proven empirically effective among African American and Hispanic parents—of Smart and Secure Children, [25,26] an empirically supported, community-based parenting intervention for parents of young children from racial/ethnic minority groups. To identify specific targets for the intervention, we conducted qualitative interviews with 28 African American and Hispanic parents of children aged 5–9 with T1D to determine their experiences with T1D management (See Table 1). Qualitative analyses identified psychosocial, interpersonal, and environmental factors that either facilitated or impeded optimal parental involvement in T1D management. [27] We adapted the Family Teamwork intervention to address these factors by targeting diabetes-related distress in parents and youth; teaching stress-management skills and behavioral and spiritual coping strategies; suggesting ways to garner support from family, friends, and diabetes care teams; and educating participants about behavior management, mealtimes, and diabetes technologies. Using the lessons learned from qualitative interviews, our study team’s psychologists, which included the developer of Family Teamwork, created a draft 5-session intervention structure and manual.

Table 1.

Characteristics of phase 1 qualitative interview participants.

Characteristic	Hispanic/Latino (n = 14)	Non-Hispanic AA/Black (n = 14)	Total (N = 28)
	Parents (n or %)
Gender Completing Interview
Female	12	9	21
Male	1	2	3
Female and Male Dyad	1	3	4
Marital Status
Never Married/Divorced/Separated	43%	43%	43%
Married	57%	57%	57%
Primary Caregiver Age (years)
≤ 35	57%	36%	46%
≥ 36	43%	64%	54%
Primary Caregiver Highest Education
High School	36%	29%	32%
Trade/Technical Degree	29%	21%	25%
Undergraduate/Graduate Degree	36%	50%	43%
Yearly Household Income
Below $60,000	71%	50%	61%
$60,000 or Above	29%	50%	39%
	Children (% or M and SD)
Age (years)	7.9 ± 1.5	7.0 ± 1.5	7.4 ± 1.5
Female	50%	50%	50%
Diabetes Duration (years)	4.0 ± 1.5	3.3 ± 1.9	3.6 ± 1.7
HbA1c (%)	8.6 ± 1.1	9.0 ± 1.2	8.8 ± 1.1

The research team sought feedback on the adapted TEAM intervention in order to increase community stakeholder engagement and refine our intervention accordingly. The community stakeholders were two County Extension Agents from Prairie View A&M Cooperative Extension Program and the Chief Nurse and a Community Relations Specialist from the City of Houston Public Health Department; all four have professional expertise in delivering health behavior programming for local African American and Hispanic families. We convened four meetings to discuss our intervention, share our materials, and obtain input and suggestions. Feedback focused on creating engaging titles for each session; developing accompanying visuals to help effectively convey important intervention information; holding an initial session for families to share stories about their diabetes experiences to establish rapport and connection; permitting intervention attendance by extended family and social-network members; engaging a diabetes educator during one session; and facilitating a discussion about participants’ successes and lessons learned during the final session. Community stakeholders also recommended against engaging families in role-play due to family discomfort with this activity. Instead, stakeholders suggested presenting positive and negative communication scripts to engage the group. We refined the TEAM intervention protocol to incorporate these suggestions.

Table 2 summarizes the TEAM intervention outline, including topics and activities for each session. We scheduled in-person sessions for groups of 4–6 families to be held at their preferred hospital every 2–4 weeks. The group intervention sessions were designed to be co-led by a study interventionist (masters level or above, with training in behavioral aspects of T1D) and a trained parent leader. Each session included didactic information about a targeted topic related to parent involvement in T1D management, interactive reflection activities, and individual goal setting to apply the lessons learned from the session to each family’s approach to diabetes management (Table 2). The parent leader would also contact participants between sessions to review the intervention content, discuss progress with goals, and address any questions or concerns.

Table 2.

TEAM intervention session topics and activities.

Session	Topics	Activities
1 – Getting to Know You	Introductions Intervention Overview	Group/Community Building Activity – Discussion of parenting values Personal Goals Activity – What each participant hopes to get out of this program
2 – Kids and Communication	Child and Adolescent Development Family Communication about Diabetes (blood glucose, food)	Communication Activity – small group discussion of different communication scenarios Personal Goals Activity – Set goal related to communication about blood glucoses or food/mealtimes
3 – Parents as Partners	Review topic and goals from previous session Diabetes Teamwork within the Family	Child Development and Teamwork Activity – small group, review family diabetes scenarios and discuss ideas for “do’s and do not’s” Personal Goals Activity – set goal related to family teamwork Q&A Opportunity with diabetes dietician
4 – Helping Hands	Obtaining support from people outside the family – medical team, extended family, friends, neighbors, community members, online groups, etc.	Five Fingers Activity – individually identify 5 people and a specific “ask” for support/help from each Group conversation about social support – experiences, concerns, what to ask for and how Diabetes one-pager – use template to create a brief guide to share with support network regarding diabetes management basics so they may offer targeted assistance Personal Goals Activity – set goal related to asking for help/favor from someone in support network
5 – Battling Burnout	Review previous goals and topics Introduction to diabetes burnout in parents and youth, including signs/symptoms and how to get help	Identifying Burnout Activity – group discussion about signs of burnout in parents and kids Preventing Child Burnout Activity – individually, parents write what they do to prevent burnout in their children, share with a partner Decreasing Parent Burnout Activity – parents discuss strategies they use or would like to try Personal Goals Activity – set goal related to checking in with themselves/child about burnout
6 – Graduation & Growth	Review key take-away messages from intervention	Each parent describes an area in which they have grown or changed

Third, we convened a parent advisory board composed of 5 African American and Hispanic parents of similarly aged children with T1D to develop the study recruitment, retention, and data collection strategies. The study PI met with these parents 6 times to obtain their input and suggestions regarding the study’s recruitment plans, materials, and assessment battery. Feedback included wording modifications to recruitment scripts, letters, flyers, and emails. The board also advised the study team on the “T1D Research and Education Day Event” we held to launch Phase 2 pilot trial recruitment. Specifically, the board suggested speaker topics, vendors, and food menu items for the event. Finally, the board provided feedback on proposed study retention strategies and materials, completed the assessment battery, and shared opinions on the battery’s length and perceived relevance.

2.3. PHASE 2 pilot trial (feasibility, acceptability, and preliminary outcomes)

2.3.1. Aims and hypotheses

Our primary aim was to evaluate the pilot TEAM intervention’s feasibility and acceptability among African American and Latino parents of children aged 5–10 years with T1D. We set the following a priori feasibility targets as primary outcomes: 1) meeting recruitment goal; 2) families complete >75% of in-person intervention sessions and monthly telephone calls combined; 3) >75% of data are collected pre-and post-intervention; 4) the attrition rate is <15%; and 6) Parent Leaders complete 75% of scheduled between-session calls. To determine acceptability, we set an a priori target of >75% of parents rating the TEAM intervention as acceptable, and we explored themes in qualitative feedback in a post-intervention interview.

Our second, exploratory, aim was to evaluate as secondary outcomes pre- to post-intervention change in glycemic control (HbA1c) and parent and child psychosocial outcomes in a pilot randomized trial. We hypothesized that, compared to families randomized to receive standard diabetes care alone, parents participating in the TEAM intervention would show increased collaborative involvement in diabetes management and self-efficacy, and decreased diabetes burden, depressive symptoms, and diabetes impact on the family. We also hypothesized that children of parents participating in the TEAM intervention would show improved adherence and quality of life, and stable or improved blood glucose control.

2.3.2. Trial design

The Institutional Review Board approved all study procedures. Phase 2 is a pilot randomized trial design (N = 60) where families were randomized 3:1 to the TEAM intervention plus usual diabetes care (n = 45) or to usual diabetes care (n = 15). We selected a 3:1 randomization model to enhance our ability to assess intervention feasibility and acceptability and maximize the amount of feedback we would receive from participants receiving the intervention.

2.4. Participants

Parent Participants. Eligibility criteria for parent/legal guardian participants included: self-identifying as African American/Black or Hispanic; having a child between age 5 and 10 who had been diagnosed with T1D for >1 year; English fluency; and not planning to leave the geographic area during the study.

Parent Leader Participants. The Parent Leaders who were trained to co-facilitate the TEAM intervention sessions were also enrolled as study participants. Eligibility criteria for the Parent Leaders include those listed for parent participants, above, plus being ≥18 years old; having acquired a high school diploma or passed the GED exam; and being able to articulate challenges and their lived experiences in sharing with their child responsibility for diabetes management.

2.4.1. Recruitment

2.4.1.1. Parent leader recruitment.

Diabetes care providers provided interested parents’ names to study staff who then called these parents to describe the study and determine their eligibility and interest in becoming Parent Leaders. Eligible parents who indicated interest completed written informed consent via mail or consent during their child’s medical appointments.

2.4.2. Parent leader training

Parent Leaders received 8 h of leadership and TEAM intervention curriculum training from the study PI and staff prior to implementing the intervention. The TEAM interventionist also held 1-h calls with each Parent Leader between TEAM sessions to review upcoming session materials and provide feedback on the Parent Leader’s facilitation during the previous session. The TEAM interventionist was supervised by a licensed clinical psychologist.

2.4.2.1. Parent recruitment.

We used two strategies to recruit parents.

• One: Research staff reviewed the hospital Diabetes Care Center’s electronic medical record to identify African American or Hispanic children aged 5–10 years with a T1D diagnosis. All identified families were mailed brochures and invited by phone or in-person during a regularly scheduled clinic visit to participate in a “T1D Research and Education Day” event at a local museum. During the 2-h event, diabetes health care providers, social workers, diabetes educators, and psychologists engaged families in brief educational presentations and panel discussions related to T1D. Representatives from local organizations and diabetes technology companies had booths to discuss their services and products. The event also featured a professional athlete with T1D to attract attendance. He shared his personal story living with diabetes, engaged youth and family members, and provided signed memorabilia as giveaways. Lunch was served and attendees received free passes to visit the museum. The study team delivered brief educational presentations to parents about the value of T1D research, provided information about Phase 2 of the study, and invited interested families to complete written informed consent.

• Two: Following the T1D Research and Education Day, study staff reviewed the electronic medical record-based clinic schedule to identify potentially eligible parents whose children had upcoming T1D medical appointments. Staff mailed these parents a letter that described the study and contacted them 2 weeks prior to their child’s appointment to confirm eligibility and determine whether they were interested in talking with study staff via phone or before their child’s appointment to learn more about the study. Eligible parents who indicated interest in the study completed written informed consent and children aged 7–10 provided assent (child participation limited to completion of a questionnaire assessing their quality of life).

2.4.3. Assessments

Data from parent and child assessments were collected and stored in a HIPAA-compliant secure web survey platform and custom database developed by the institution’s Office of Research IT. The custom database provided an online platform for youth and parent data collection within the clinic, at home, or other convenient location. Participants received a link and personalized login information to access their questionnaires, and they were able to stop. The IT team used this database to create structured reports on data collection (participant demographics, etc.) that we used to monitor study progress, control data collection quality, and assist with reports during quarterly Data Safety and Monitoring Board Meetings. Data were collected at baseline and 1-year post baseline.

2.4.3.1. Primary outcomes of feasibility and acceptability

2.4.3.1.1. Recruitment goals.

We used recruitment logs that tracked how many and which eligible families enrolled, which did not enroll, their reasons, to evaluate recruitment success.

2.4.3.1.2. Percentages of in-person and telephone sessions completed.

We tracked the percentage of in-person and telephone sessions parents completed by logging each such session into the study database.

2.4.3.1.3. Intervention acceptability.

We used an investigator-developed survey that asked parents to rate intervention features on a 5-point scale (“strongly disagree” to “strongly agree.”) and tallied the results to determine the percentage of parents who found the intervention acceptable.

2.4.3.1.4. Data collection completion.

We used the electronic study database to determine the percentage of families from whom we gathered complete data (objective, self-report) post-intervention.

2.4.3.1.5. Attrition rate.

We calculated the attrition rate by dividing the total number of families from whom we had gathered complete data post-intervention by the total number of families enrolled.

2.4.3.1.6. Percentage of monthly calls completed by Parent Leaders.

We had Parent Leaders complete monthly logs that recorded the number and duration of monthly calls completed with each participant.

2.4.3.2. Intervention fidelity.

Group sessions were audio-taped. The research staff reviewed 10% of each of the 6 sessions to verify intervention fidelity (using a critical-intervention-component checklist and that has a “yes vs. no” response scale).

2.4.3.3. Secondary outcome measures.

The team assessed HbA1c during the children’s regular quarterly visits. The clinic nurse procured blood samples via finger-sticks using standard clinic procedures and then used the BAYER DCA 2000 Hemoglobin A1C Testing Analyzer [28] to analyze them immediately.

2.4.3.3.1. Blood glucose (BG) monitoring (adherence).

Blood glucose was collected at each routine diabetes clinic visit by downloading the memory from each patient’s BG meter with device-specific software. This download yields the mean number of BG checks completed per day for the previous 14 days. We used the BG meter’s memory to calculated the percentage of days with no completed BG checks.

2.4.3.3.2. Adherence to multiple diabetes management behaviors.

We used our 9-item parent-report questionnaire—the 9-item Diabetes Self-Management Questionnaire (DSMQ)—as a supplement to the objective adherence measure of blood glucose monitoring frequency. Higher scores indicate better adherence. Internal consistency is 0.76.

2.4.3.3.3. Child diabetes quality of life.

We used the PedsQL^™ 3.2 Diabetes Module, a 32-item questionnaire, to assess the children’s health-related quality of life. We used a 5-point scale for children ages 8–9 years (0 = Never; 4 = Almost Always) and a 3-point scale for children ages 5–7 years (0 = Never; 4 = A lot). Higher scores indicate higher diabetes-related quality of life. Average internal consistency is 0.71.⁸²

2.4.3.3.4. Parent involvement in diabetes management tasks.

We used the 17-question Diabetes Family Responsibility Questionnaire (DFRQ) to measure parent involvement in diabetes management tasks [29]. Internal consistency ranges from 0.87–0.90.

2.4.3.3.5. Parent self-efficacy for diabetes management.

We used the 8-question Parental Self-Efficacy Scale for Diabetes Management [30] to assess parental confidence in managing their child’s diabetes. Higher scores indicate greater self-efficacy. Internal consistency is 0.84.

2.4.3.3.6. Parent diabetes emotional burden.

We used the 18-question Problem Areas in Diabetes Revised for Parents (PAID-PR) [31] survey to assess parent’s perceived emotional burden associated with caring for a child with diabetes. Internal consistency is 0.87.

2.4.3.3.7. Depressive symptoms.

The Center for Epidemiological Depression Studies-Depression (CES-D) [32] scale is a 20-question self-report that tracks depressive symptoms over the past week. Participating parents rated their own symptoms (not their child’s) on a 3-point scale from 0 (“rarely or none of the time”) to 3 (“most or almost all the time”). Higher scores indicate greater symptoms. Internal consistency coefficients are 0.88 to 0.91. [32].

2.4.3.3.8. Parent emotional social support.

We used the 2-Way Social Support Scale’s [33] 7-question Receiving Emotional Support subscale to assess the level of emotional support parents received. We used a 6-point Likert scale ranging from 0 (“not at all”) to 5 (“always”). Higher scores indicate higher levels of emotional-social support. Internal consistency is 0.92. [33].

2.4.3.3.9. Impact of diabetes on the family system.

The Diabetes Family Impact Scale [34] is a 15-question survey that assesses how diabetes impacts family members’ well-being, family routines, economic status, parental functioning at work, and youth schooling. Internal consistency is 0.84. [34].

2.4.4. Randomization

Families were randomized 3:1 to the TEAM intervention plus standard diabetes care or to standard diabetes care alone after they completed a baseline assessment. To ensure concealment, a random numbers table generated by a computer program created by the institution’s data management specialists carried out permuted block randomization.

2.4.5. TEAM intervention

Families randomized to the TEAM intervention were scheduled to attend 6 group sessions conducted over a 6- month period. Eight groups were formed with a maximum of 6 families per group. Interventions sessions for four of the eight groups were held in one of two locations of the integrated delivery system of the pediatric tertiary care hospital. Due to the onset of the COVID-19 pandemic half-way through the pilot trial, four of the eight groups were conducted virtually via the Vidyo® tele-health delivery platform.

2.4.6. Program reactions (exit interviews)

To help identify reactions to the program, we asked parents about their experience with the TEAM intervention, satisfaction, and suggestions for modifications.

2.4.7. Data safety and monitoring

We timely collected, tracked, and reported all data, safety-related information, and adverse events to the IRB and the Data and Safety Monitoring Board (DSMB). The DSMB consisted of 4 members with expertise in medical care of children with T1D and behavioral interventions. The DSMB convened every 6 months by conference call during Phase 2 when the intervention was implemented, and as needed to ensure that the participants in the trial received all appropriate protections.

2.4.8. Planned analyses

2.4.8.1. Primary outcomes.

To determine feasibility, we will calculate the number of families who enroll in the study, the average percentage of number of sessions attended (in-person and telephone sessions combined), the percentages of enrolled primary parent participants with complete pre- and post-intervention questionnaire data, the percentage of families who drop-out of the study, the average percentage of monthly telephone calls completed by Parent Leaders, and the percentages of parents who rate the intervention as acceptable. We will calculate each parent’s average score on the Treatment Evaluation Inventory to determine acceptability. An average score of >4 will indicate acceptability. A random sample of 10% of the in-person intervention sessions will be used to determine fidelity. A fidelity score will be determined by calculating the percentage of completed critical intervention components.

2.4.8.2. Secondary outcomes.

We will determine descriptive information regarding differences between families who participate in the FT-P intervention and those who are randomly assigned to the control group and determine children’s HbA1c by determining regression estimated means (95% CI) from general linear mixed models with fixed effects for arm, time, and arm-time interaction term. We will provide descriptive information on the secondary outcomes of adherence, parent involvement in diabetes management tasks, self-efficacy, emotional burden, depressive symptoms, social support, family impact, and child quality of life by determining effect size estimates from linear mixed models.

3. Discussion

The rigor and impact of the current empirical evidence for informing approaches to prevent glycemic control deterioration when African American and Latino children reach adolescence is limited by a lack of published trials of interventions that improve diabetes outcomes among younger school-aged children before family diabetes management routines have been established. No studies have examined whether parent-peer-led interventions might successfully reach minority families of children with T1D, despite evidence that they are acceptable, effective, and cost-effective for minority parents of children with other chronic conditions. [35,36] The study to pilot test the TEAM Intervention seeks to fill these gaps. We anticipate the parent-peer delivered intervention will improve parental involvement in diabetes management and optimize treatment adherence and glycemic control.

This study contributes to the sparse literature by carefully developing and evaluating a tailored approach to improve disparities found in African American and Latino youth with T1D. The few studies that have examined potential solutions to these disparities concentrated on African American adolescents [17,18]; Latino youth have not been studied. Tailored behavioral interventions that comprehensively target barriers to parental involvement in T1D management and adherence in racial/ethnic minority families have the potential to most effectively improve glycemic control.

The study is innovative because it seeks to enhance research recruitment and retention through engagement with African American and Latino families, thereby increasing the intervention content’s relevance. Recruitment and retention is especially difficult among minority groups with chronic illness because of mistrust and other historical, cultural, and socioeconomic barriers that impede engagement. [37] Hosting Research and Education Day events in the community setting has proven effective in overcoming such barriers and increasing recruitment and retention of minority families with children with other chronic conditions, like sickle cell disease, [38] but has not yet been applied to T1D.

Overall, the study findings will provide important information for a larger, fully-powered, randomized, controlled trial to examine whether optimizing appropriate parent involvement during the school-age years will increase T1D treatment adherence and stabilize or improve glycemic control in African American and Latino school-aged children. Although effective interventions have been developed and evaluated for adolescents, we are unaware of any published interventions that improve health outcomes for minority school-aged children. Therefore, this research has the potential to have a significant public health impact by optimizing parental involvement in diabetes management before diabetes management routines are solidified, and more difficult to modify, among youth with a higher risk of disparate diabetes health outcomes.