A Comparison of Two Internet Programs for Adolescents with Type 1 Diabetes: Design and Methods

Abstract

Implementing psycho-educational programs for youth with type 1 diabetes in clinical care and reaching diverse youth with type 1 diabetes is challenging due to youth, provider, and organizational barriers. This study was designed to compare the effectiveness of an internet coping skills training program with a control condition of internet diabetes education. Each program consists of 5 weekly interactive lessons; the coping skills training program also provides the ability for youth to interact with each other as well as a health coach. Approximately 300 youth with type 1 diabetes will be recruited to participate in this multi-site clinical trial. The primary outcomes are metabolic control, quality of life, and family conflict. Secondary outcomes include stress, coping, self-efficacy, and social competence. Usage, satisfaction, and cost will also be evaluated. In addition, mediators and moderators to intervention effects will be explored. An internet based psycho-educational program for youth with type 1 diabetes may be a promising approach that can be easily be integrated into clinical care.

1. Introduction

Type 1 diabetes (T1D) is the most common severe chronic disorder of childhood, with approximately 15,000 new cases diagnosed annually in the United States. T1D is more common in non-Hispanic white youth, followed by non-Hispanic Black and Hispanic youth.[1, 2] T1D is an autoimmune disorder characterized by alterations in glucose, protein, and fat metabolism due to the absolute lack of insulin. Diabetes is the 6th leading cause of death in the US, and adults with diabetes are twice as likely to die prematurely from complications compared to adults without diabetes.[3] Diabetes also extracts a huge economic burden, with the cost of diabetes in direct and indirect costs estimated at $174 billion per year, much of which is related to the care of complications.[4]

Youth with T1D transitioning to adolescence (age 11–14 years) are a vulnerable population. They demonstrate deteriorating metabolic control, poor self-management, more social stressors, higher psychosocial distress, and lower quality of life compared to youth with T1D at other ages.[5] Psycho-educational interventions for adolescents and youth with T1D have been shown to improve metabolic control of diabetes as well as psychosocial adjustment and quality of life,[6–8] but implementing these evidence-based programs in clinical care and reaching diverse adolescents with T1D is challenging due to provider and organizational barriers, such as lack of time, financial resources, expertise, and personnel. Rapid advances in technology and access to the internet have made the internet not only a viable mode for the delivery of psycho-educational interventions, but a platform that can be widely disseminated and reach diverse adolescents with T1D. Access to the internet is becoming increasingly available nationwide and has risen to its highest level ever, with 93% of youth using the internet regularly.[9, 10] The internet, therefore, represents an efficient way to deliver psycho-educational interventions for diverse adolescents with T1D.

The goal of the TEENCOPE clinical trial is to test the efficacy of an internet version of a successful group-based psycho-educational program for young adolescents with T1D (Coping Skills Training/CST) [6] in a diverse sample of youth throughout the United States. Youth transitioning to adolescence are targeted in order to prevent the poorer outcomes associated with adolescence.

2. Primary Research Goals

The primary hypotheses being tested in the TEENCOPE study are: (1) youth with T1D who receive an internet coping skills training intervention (TEENCOPE) will demonstrate better physiologic (metabolic control), psychosocial (quality of life), and family adaptation (decreased family conflict) compared to youth with T1D who receive a control condition of internet diabetes education (Managing Diabetes); and (2) youth with T1D who receive TEENCOPE will demonstrate lower perceived stress and improved coping skills, self-efficacy, social competence, and self-management compared to adolescents with T1D who receive the internet education intervention. Secondary aims of the study are to evaluate the mediating effects of stress, coping, self-efficacy, social competence, and self-management on relationships between participation in the internet programs and the primary outcomes of metabolic control, quality of life, and family conflict. Our hypothesis is that stress, coping, self-efficacy, social competence, and self-management will mediate the effects of the intervention. In addition, usage, satisfaction and costs of the programs will be described.

3. Study Design

3.1 Overview

A total of 300 youth with T1D will be recruited from 4 U.S. sites over approximately 2.5 years. Youth will be randomized to TEENCOPE or the internet diabetes education program (Managing Diabetes). Both programs will consist of 5 weekly, interactive sessions that youth complete asynchronously. Youth in both programs will be allowed to access the intervention sites for approximately 3 months. After 12-month data collection is completed, youth will be encouraged to cross-over and complete the alternate program.

3.2 Conceptual Framework

Stress-adaptation models provide a framework for the study of psycho-educational interventions to promote adaptation to chronic illness and posit that adaptation may be viewed as an active process whereby the individual adjusts to the condition. We developed a framework to guide our studies of psycho-educational interventions, including CST and education in youth with T1D.[11–13] The framework suggests that pre-existing characteristics, such as age, gender, race/ethnicity, socio-economic status (SES), and pubertal status of the child as well as individual responses (depressive symptoms) moderate the level of individual adaptation. In addition, stress/coping, self-efficacy, social competence, and self-management mediate these outcomes. Psycho-educational interventions are hypothesized to influence the individual’s adaptation directly and indirectly.[13]

3.3 Sample

The sample of 300 participants was determined by several power analyses based on the effect sizes seen in our previous studies of adolescents, our pilot study of the internet CST intervention, and colleagues’ studies of adolescents with T1D. For a conservative impact on metabolic control (metabolic control is constant in the treatment group and increases by 0.5% at one year in the control group), a univariate two-group mixed effects linear regression model using the Greenhouse-Geisser correction to nominal degrees of freedom will have 80% power to detect an interaction between groups and time when the significance level is 0.05 and the sample size in each of the two groups is 64 per group. For other outcomes, estimates range from 58 per group for family conflict, 36 per group for QOL, and 26 per group for self-efficacy. Assuming a conservative estimate of 20% attrition (attrition was 15% at one year in our previous study), a total of 154 participants would be required for a full test of the primary hypotheses being tested, assuming equal sample sizes.

The achievement of the secondary aim will require a larger sample size for the mediator analysis. Conservative statistical rules of thumb for mediator analyses recommend 30 participants per predictor variable; thus with 8 predictor variables (5 mediating variables, age, gender, duration), a sample size of 240 participants is recommended.[14] Assuming approximately 20% attrition, a total of 300 participants would be required for a full test of the mediator hypothesis being tested.

3.4 Eligibility

Youth will be eligible for the study if they are between the ages of 11 and 14 years; school grade appropriate to age within one year; have had T1D for a minimum of 6 months; have not been exposed to TEENCOPE pilot materials; have no other significant health problem that compromises self-management (such as celiac disease) or that would interfere with completion of the program (such as an untreated psychiatric condition); and have access to a computer with high-speed internet service. The rationale for these criteria are based in the need to study youth transitioning to adolescence who have adjusted to the diagnosis and are not dealing with another chronic condition that would complicate adaptation to diabetes. If youth do not have home internet, research staff will assist study participants to gain access at school, a local library, or clinic.

3.5 Recruitment and Informed Consent

Youth from pediatric diabetes clinics associated with the 4 academic medical centers (Yale, The Children’s Hospital of Philadelphia, University of Arizona, and University of Miami) will be enrolled in the study. Each site will receive unique institutional review board approval after general study approval at the parent site (Yale). Study materials and procedures will be consistent between sites with some exceptions to accommodate unique needs of individual sites. Study staff will approach potential participants at clinic during follow-up healthcare visits. Youth will be invited to participate in the study, eligibility will be assessed, and IRB-approved consent/assent forms and HIPAA authorization will be signed.

3.6 Procedures

3.6.1. Email confirmation, Randomization and Enrollment

After informed consent, families will be asked to respond to an email sent from the study site. Once confirmed, this email will become the logon id for study participants during the intervention phase and online data collection.

Youth with confirmed email communication will then be randomized by an automated computerized process at the Yale site to either TEENCOPE or Managing Diabetes in blocks of 10 per site. Clinicians, investigators, and research associates who conduct recruitment and follow-up will be blinded to treatment assignment.

Randomization will trigger the release of an automated email from Yale instructing teens to visit the data collection website to complete baseline questionnaires; however, group assignment will not be revealed to participants at this time. The email will contain instructions, a computer generated password, and encouragement to complete all questionnaires. Youth will be considered “enrolled” in the study once they complete baseline data collection.

3.6.2 Intervention schedule

After the completion of baseline questionnaires, an automated email will be sent to youth thanking them for completing questionnaires, informing them of their intervention assignment, and instructing them to either wait up to a month for the formation of a pod (TEENCOPE), or wait for the release of their first session (Managing Diabetes). Because the original CST intervention was delivered in small groups, pods (n=8–10) of youth randomized to TEENCOPE will be formed as youth are enrolled to simulate the group environment.

3.7 Interventions

3.7.1 TEENCOPE

The TEENCOPE program was developed based upon an in-person CST program for youth with T1D.[6] An interdisciplinary team at Yale that included experts in CST, information technology experts, and adolescents with T1D who had previously participated in the group-based CST program and their parents, systematically translated the in-person lessons to an innovative and appealing graphic novel format that could be presented over the internet. A cast of ethnically diverse characters with T1D was created to present challenging social situations, approaches to solving problems, as well as consequences to decisions. To assure that the program was culturally competent, diverse youth with T1D were involved in the design and development of the program to enhance relevance and acceptability of program presentation and content.[15] A description of the internet program development has been published.[13, 15]

The TEENCOPE program focuses on the coping skills of problem solving, social skills training, cognitive behavior modification, assertive communication, stress reduction, and conflict resolution (Table 1). The overall goal is to increase coping and self-efficacy by retraining inappropriate or non-constructive coping styles and forming more positive styles and patterns of behavior. Each lesson is highly interactive and takes approximately 30 minutes to complete. Upon completion of sessions, responses to interactive aspects will be posted on a personal profile so that participants will be able to access each other’s responses and learn from each other. At the end of each lesson, participants will be asked to practice the new coping skills and to share experiences on a discussion board. A moderator will provide feedback to participants to promote positive coping skills and assure that postings are appropriate.

Table 1.

TEENCOPE (Coping Skills Training) Session Content

Session	Description
Introductory animation	Introduction to the “coach”/moderator. Discussion of session content, structure, online rules. Introduction to website capabilities, sharing on discussion board.
1. Self-Talk	“Coping Skills” – what they are, how they help. “My diabetes story” – introduction of self and consideration of positives and negatives associated with diabetes. Identification of feelings to understand associations between feelings, thoughts, and behaviors. Presentation of a cognitive model of “self-talk” to further explore links and responses.
2. Communication Skills	Exploration of effective communication – barriers/ improving communication. Discussion about styles of communication (passive, aggressive, and assertive) and assumptions about others. Skill practice and discussion about managing difficult or embarrassing moments.
3. Social Problem Solving	Training in a step-by-step model of social problem solving. Presentation of challenging diabetes-specific situations, with encouragement to consider/discuss responses and alternatives.
4. Stress Management	Reflection on the mental and physical effects of stressful situations. Training in a variety of stress management techniques, including deep breathing, muscle relaxation, and guided imagery.
5. Conflict Resolution	Discussion about different conflict styles (avoidance, giving in, confrontation, being humorous, and problem solving). Animal photos depict styles, participants identify style. Reflection and encouragement to consider/discuss the most positive ways to handle conflict and difficult situations.

3.7.2 Managing Diabetes

A website on diabetes education (Managing Diabetes) was also carefully designed to be age-appropriate, acceptable to diverse youth with T1D, and to serve as a control condition. The education internet intervention modeled an in-person program used as the control condition in our previous studies and focused on diabetes problem solving to improve self-management during the transition to adolescence.

As in TEENCOPE, Managing Diabetes consists of 5 lessons that take approximately 30 minutes to complete and will be released to teens once weekly for 5 weeks. Case studies and problem-solving exercises are used to enhance teens’ capacity to make diabetes-related decisions. While all youth with T1D receive ongoing education in routine care, Managing Diabetes was designed to review knowledge and problem-solving skills on intensive insulin regimens (multiple daily injections or pump), carbohydrate counting, sports and sick days, and healthy lifestyles (Table 2). The lessons are visually enhanced with pictures and highly interactive in that programmed responses give youth tailored feedback on their answers to questions and problem-solving activities.

Table 2.

Managing Diabetes (Diabetes Education) Session Content

Session	Description
1. Healthy Eating	Three basic food groups (carbohydrates, protein, and fats). Carbohydrate counting and fiber. Discussion of choosing food wisely (limiting sugar, reading food labels, and increasing intake of fruits and vegetables). Sharing of healthy recipes.
2. Exercise	Health benefits of exercise. Consideration of diabetes and exercise. Guidelines for exercise when you have diabetes. Exercise problem solving when using multiple daily injections or the pump with examples.
3. Glucose Control	Glucose control, target glucose, and blood sugar trends. Emphasis on how participants feel when blood sugar is well controlled, and how good blood sugar control prevents health complications. Problem solving and instruction in adjusting insulin when using multiple daily injections or the pump with examples.
4. Preventing & Managing Sick Days	Hints to prevent sick days. A sick day kit for diabetes management. Guidelines for sick days and when to call your nurse or doctor. Exercise and sick-day problem solving. Fun foods for sick days.
5. Diabetes Technology & Research	New developments in diabetes technology and research (meters, pumps and pump features, continuous glucose monitoring systems, real-time glucose monitoring systems, pump and real-time glucose monitoring systems). Diabetes organizations that are resources for information or referral.

The primary differences between the Managing Diabetes and TEENCOPE websites are in the content (diabetes education vs. coping skills) and in the use of virtual role models in TEENCOPE who demonstrate the coping skills, decisions, and consequences of decisions in a virtual world very similar to that of the targeted population. In addition, TEENCOPE allows participants to obtain feedback from peers as well as a professional, while Managing Diabetes has no interaction. In Managing Diabetes, youth complete sessions individually and there is no discussion board.

3.8 Measures

Data will be collected online at baseline, 3, 6, 12, and 18 months. Physiologic data will be collected by retrospective chart review. The times of data collection were selected to reflect immediate outcomes (3 and 6 months), and longer-term sustainability (12 and 18 months).

3.8.1 Physiological Adaptation

Glycosylated Hemoglobin (HbA1c) is routinely measured every 3 months in youth with T1D. The glycosylation of the hemoglobin molecule provides objective criteria of metabolic control over the past 8 to 12 weeks. These analyses will be performed using the Bayer Diagnostics DCA2000®, which provides results in 6 minutes on a fingerstick blood sample (normal range = 4.2–6.3%). The reliability of this method has been documented to be high.[16] If youth have HbA1c measured using alternate methods (i.e. HPLC, Roche Tina-quant), statistical analyses will be performed to ensure that there is no significant variability in measurements using different methods. Since HbA1c levels will be collected from a retrospective chart review, participant clinic visits will be monitored by research assistants (RAs) to assure that HbA1c data are completed within 1 month of online data collection times. If youth miss their appointment, they are contacted and urged to make an appointment within the 1 month window.

3.8.2 Psychosocial Adaptation

Psychosocial measures were selected primarily because they have been used in previous studies of youth with T1D and have been shown to be reliable and valid for the target population. In addition, we carefully chose instruments that are consistent with our conceptual framework. For example, there are multiple instruments for measuring self-management in youth with diabetes, but the majority measure adherence to the diabetes regimen. The SMOD-A had a stronger conceptual fit with our definition of self-management that goes beyond adherence.

Quality of life will be measured by the Pediatric Quality of Life Inventory, which measures quality of life in children with chronic health conditions.[17] The instrument consists of a 15-item core measure of global health-related quality of life and a 28-item supplemental measure assessing diabetes-specific quality of life. High reliability and validity have been established in various clinical and community samples.[17, 18] In a sample of children with type 1 and type 2 diabetes, alpha coefficients were .88 for the core measure and .71 for the diabetes-specific measure. Discriminant validity, using the known-groups approach, was demonstrated for children with type 1 diabetes and for healthy children.[19]

3.7.3 Family Adaptation

The revised Diabetes Family Conflict Scale will be used to evaluate diabetes treatment conflict.[20] The scale is a 19-item questionnaire adapted from the Diabetes Responsibility and Conflict Checklist[21] and is used to measure the degree of conflict between family members on diabetes management activities. Alpha coefficients have been high in samples of youth between ages of 8–18, ranging from .90 to .96. Original studies showed a significant correlation with HbA1c (P<.01).[20]{Rubin, 1989 #893; Pendley, 2002 #1111} {Anderson, 1999 #416}

3.7.4 Mediators

Stress will be measured by the Perceived Stress Scale, a 14-item scale that evaluates the degree to which situations in one’s life are unpredictable, uncontrollable, and overloading.[22] Reliability estimates have been high, with alpha coefficients ranging from .84 to .86. Concurrent validity has been demonstrated with other measure of stress and behavioral outcomes such as health care utilization.[22]

Coping style in response to diabetes-related stressors will be measured with the Responses to Stress Questionnaire.[23] The first 10 items of the measure list stressors specific to adolescents with T1D,[24] followed by 57 items asking how the individual responds to these stressors. The scale includes three coping factors: primary control engagement coping (problem solving, emotional modulation, emotional expression), secondary control engagement coping (positive thinking, cognitive restructuring, acceptance, distraction), and disengagement coping (avoidance, denial, wishful thinking). The instrument has good reliability and validity, including internal consistency (alphas from .73 to .85), convergent validity in reports of parents and children, and construct validity as reflected in confirmatory factor analyses.[23, 25] To control for response bias and individual differences, proportion scores will be used for all analyses.

The Self-Efficacy for Diabetes Scale measures self-perceptions of youth with T1D about their personal competence and resourcefulness for successfully managing their diabetes.[26] The scale consists of 35 items in three subscales: diabetes-specific self-efficacy (24 items); medical self-efficacy (5 items); and, general self-efficacy (6 items). Items have been modified from the original version to include current T1D modalities (ie., pump therapy). Reliability coefficients range from .90–.92 for the total scale and the diabetes-specific subscale to .60 for the general subscale. Validity studies demonstrate that the scale has content and discriminant validity.

Social competence will be measured by the social acceptance sub-scale of the Self-Perception Profile for Adolescents.[27]{Harter, 1982 #1103; Harter, 1988 #1141} This sub-scale consists of 5 items on ability to make friends and feelings of acceptance and has evidence of good internal consistency (alpha = .75 to .82). The instrument also has evidence of adequate convergent and discriminant validity.{Harter, 1982 #1103; Harter, 1988 #1141}

Youth’s diabetes self-management will measured with the Self-Management of Type 1 Diabetes in Adolescence, a 52-item scale that measures 5 domains of self-management of diabetes (collaboration with parents, diabetes care activities, problem solving, communication, and goals). Adequate reliability has been demonstrated with sub-scale alpha coefficients ranging from 0.71 to 0.85 in youth with T1D. Evidence of construct validity has been confirmed by significant correlations with sub-scales and HbA1c.[28]

3.8.5 Moderators

Since metabolic control worsens partially as a function of adolescent development, pubertal status will be measured with the Measure of Pubertal Development.[29] This is a self-report measure consisting of 5 gender-specific items that ascertains pubertal status for youth ages 9–15. Alpha coefficients for pubertal status range from 0.68 to 0.83. Youth will see only the questions appropriate for their gender. Self-reports of pubertal status have been shown to be internally consistent.

The Children's Depression Inventory (CDI) will be used to measure self-reported depressive symptoms, including disturbance in mood, self-evaluation, vegetative functions, and interpersonal behaviors.[30] It contains 27 multiple-choice items and a criterion score of 13 has been established for identifying clinical depression.[31]. The instrument has been used extensively in community samples of youth, in youth with mental health problems, and in youth with T1D. Concurrent and discriminant validity have been demonstrated, and reliability estimates have been high, with alpha coefficients ranging between 0.71 to 0.87.[30, 32, 33]

3.8.6 Usage and Satisfaction

Usage of the two internet programs will be evaluated by compiling summary reports of the number of times participants log onto the program and number of posts to the discussion board. Satisfaction with the programs will be evaluated by a survey on perceptions of content, enjoyment, and navigation of the website.

3.8.7. Costs

Costs of the program will be estimated by calculating the costs of each program within the study time period. Research logs will be kept to record the amount of time spent overseeing the programs by administrative personnel (setting up accounts, assuring smooth delivery of programs, uploading sessions), clinical personnel (moderating lessons and discussion board, intervening for any clinical problems), and technical personnel (maintaining internet sites and secure systems, correcting technical problems). Research logs will also record any direct expenditures related to the intervention delivery. We have kept careful records of the cost of the intervention development, so that we can amortize those costs over the usage phase as well.

3.9 Follow Up

3.9.1 Data collection schedule and incentives

Youth and their parents will receive a phone call and an automated email with the release of each data collection survey set (3, 6, 12 and 18 months). At 8 months, youth will be mailed a progress report reminding them about study events and showing their progress. In addition, a postcard will be mailed to youth at 11 months letting them know that the 12-month data collection point and the opportunity for trying out the alternate program are approaching.

Youth will receive escalating compensation in the form of a gift card to a popular department store for completion of online data collection ($20.00 – S30.00). If youth complete data collection within a week of questionnaire set release, he/she will be entered into a drawing with 25 other youth to receive an additional $25 gift card.. No incentives will be provided for completion of the interventions.

3.9.2 Tracking progress

Participation in the program will be carefully monitored and follow-up procedures will be undertaken with the goal of 80% participation in lessons and data collection. The administrative system will generate a daily digest that lists youth participation in lessons and data completion which will be used to maintain a backup spreadsheet of study progress, flag teens that score high on the CDI, and notify the TEENCOPE moderator of website activity. Once per week, reports will identify youth with new questionnaire and lesson releases, youth behind in questionnaire and lesson completion, youth due for clinical data collection, and youth due for upcoming questionnaire releases and will be available to the other sites. Bi-monthly compliance reports will be generated to oversee study activity and refine policies and procedures.

3.10 Data analysis

3.10.1 Aim 1: Metabolic control, quality of life, and family conflict – primary endpoints

The sample and each of the variables will be described using frequency distributions and appropriate summary statistics for central tendency and variability. Psychometric analysis of the instruments will be performed. Variability of each item will be assessed, and alpha coefficients of reliability will be calculated. Although there are no a priori reasons to expect that baseline dependent variables will differ by group assignment because of the delimitation of the sample and random assignment, these assumptions will be tested with t-tests or Chi square tables, depending upon the level of measurement. If differences are found, they will be statistically controlled in the remaining analyses.

The principal aim of the study is to test the hypotheses that youth who receive the TEENCOPE intervention will demonstrate better physiologic (metabolic control), psychosocial (quality of life), and family adaptation (family conflict) than youth who receive an internet education intervention. To accomplish these aims, we will fit a series of mixed effects linear regression models (repeated measures ANOVA with arbitrary within-subject correlation structures) in the SAS PROC MIXED (for continuous outcomes) and the generalized estimating equations methods provided by PROC GENMOD (for dichotomous outcomes) for the primary outcomes over time. Intent to treat procedures will be used. Repeated longitudinal measures within the same participant are temporally correlated and an autoregressive structured working correlation matrix will be assumed. We will include indicator variables to test for differences of the experimental (TEENCOPE) and control groups. Baseline covariates and moderators, such as age, duration of T1D, depressive symptoms, or initial metabolic control, will be included in these regression models to test for their influence and to see if there are synergistic interactions with the effect of the programs. Sub-group analyses will also be undertaken to determine the effect of ethnicity, access (to computer), internet usage, and clinical site on outcomes. Significant effects will be treated as a covariate in the mixed model analyses of outcome variables. For the secondary outcomes, it is possible that the dependent variables will be correlated. If so, we will expand our mixed models analysis to account for these correlations.

3.9.2 Aim 2: Mediation, cost, usage, and satisfaction

Regression analyses will be performed to investigate the mediating and indirect effects, if any, of stress, coping, self-efficacy, social competence, and self-management on the relationships between participation in TEENCOPE and each of the primary outcomes of metabolic control, quality of life, and family conflict. For variables that meet the criteria for mediation, we will examine if TEENCOPE has better improvements in the potential mediator and also test a significant relationship between the change of the potential mediator and the better primary outcomes at the primary end point. For the selected mediators satisfying that criteria, we will estimate these relationships using multiple linear regression models.

The resulting regression coefficients and standard errors will then be entered into the formulae for the Sobel test[34, 35] to determine if and the extent to which mediation has occurred. The Sobel test uses an asymptotically normal distributed statistic that is based on the distribution of the product of the two regression coefficients representing the effect of TEENCOPE on the mediator and the effect of improvement in the mediator on primary outcomes after controlling for intervention effect. When the normality assumption is not met, the bootstrap method will be employed to estimate the mediation effect.[36] Variables that do not meet the criteria for mediation will be evaluated for indirect effects using regression analyses.

An additional secondary aim is to describe the usage, satisfaction, and costs of the internet programs. Usage will be evaluated by calculating summary statistics for each program (average number of sessions completed, number of times a participant logged on, and the total logged in time per participant). Comparisons between the TEENCOPE and the Managing Diabetes websites will be completed using t-test and Chi square analyses. Usage will be evaluated also as a potentially confounding variable to intervention efficacy by using a mixed model analysis that accounts for a main effect of usage or by an interacting effect of usage over time on each primary outcome. Satisfaction will be evaluated by summarizing program evaluation surveys by items and by overall satisfaction. Satisfaction scores of the two internet sites will be compared using t-test analyses. General comments will be summarized by site and content analyzed to identify positive aspects, negative aspects, and suggestions for improvement.

Costs of the programs will be described by calculating the time spent on each component of programs (administrative, clinical, technical) added to the cost actually spent on the intervention development. Time spent on intervention delivery will be multiplied by appropriate wage rates (including fringe benefits) to calculate the overall cost of the program delivery. Direct costs will also be calculated. Separate cost calculations will be determined for the intensive aspect of the program (during sessions) vs. the less intensive phase (discussion board only). Estimates of participant time spent will also be calculated.

4. Oversight

Website administration, subject management, and data management will be centralized at Yale. Recruitment and follow-up will be managed at individual study sites. Each of the sites will have a study principal investigator (PI) who will oversee site activity, and an RA who will handle recruitment and follow-up. Yale has two PIs, a project manager who will communicate with sites, a site RA and graduate nursing students for recruitment and follow-up, and a clinical psychologist to moderate the discussion board and provide advice on any psychological concerns (such as high scores on the CDI).

In addition to oversight by the IRB, there are two mechanisms by which study conduct, integrity, and safety will be overseen. An Executive Committee will be formed to assume responsibility for overseeing the performance of the trial. It will be composed of all site PIs and will be chaired by one of the PIs at Yale. The Executive Committee will meet once monthly by conference call to review the activities of the trial, including progress, recruitment, performance, and problems. The committee will also advise on issues central to the achievement of trial goals and objectives. A Data Safety and Monitoring Board (DSMB) will be formed to ensure human subject safety and data integrity. The DSMB will be chaired by a pediatric diabetes expert, and will include a pediatric behavioral health specialist and a biostatistician. The DSMB will meet at least twice yearly in person or by conference call to review study progress and adverse events.

5. Discussion

While there have been several clinical trials demonstrating the efficacy of psycho-educational interventions in transitioning youth,[6, 37, 38] cost and clinic limitations have made the incorporation of such interventions into routine care difficult.[39] While our previous work with teens showed strong effects of CST on HbA1c and quality of life when delivered in small groups, less than 50% of eligible youth were able to participate due to their busy schedules of school and activities. In an effort to reach more youth, we developed the internet programs.

Internet interventions standardize program content, can be targeted to specific ages and developmental phases, allow for social interaction, can be easily updated, and have the potential for wide dissemination. Therefore, the internet represents an appealing, effective, and time-efficient way to deliver psycho-educational interventions for youth with T1D. Internet-based interventions that can reach large numbers of youth with T1D have potential to result in significant improvements in long-term health, as well as reductions in the costs of care for diabetes-related complications. Thus, the focus of our internet-based interventions was to mimic CST as delivered in groups and to enhance self-management capabilities in adolescents.

Sampling decisions were based on a few key concerns. First, although teens with T1D demonstrate poorer outcomes, we believed that it would be more cost-efficient to use the internet to reach youth transitioning to adolescence to prevent the declines seen in adolescence. Thus, we targeted the interventions and the sampling frame to early adolescents, age 11 to 14 years. Second, there is a dearth of research examining the ability of internet interventions to reach diverse youth. While there still is evidence of a digital divide with access to the internet lower in African American, Hispanic, and low-income households, there is a trend for it to be decreasing.[9] The sites for this trial were carefully selected to enhance recruitment of a diverse sample of youth with T1D. The sampling goal of this study is 75% White, 15% Hispanic, and 10% Black. Specific strategies were undertaken in the design and development phase of this project in order for programs to be engaging to diverse youth with T1D. Procedures will be developed to assist youth without internet access at home to gain access at public resources or the clinic. These procedures will be evaluated by examining recruitment, access to the internet, and usage by race/ethnicity and income.

Several alternative designs were considered in the development of this study. We considered a 3-group design, with TEENCOPE, Managing Diabetes, and the group-based inperson CST program. This design was rejected because a major objective was to increase the number of youth that the program would reach. Since our previous data showed that more than 50% of youth would decline participation, we determined that the 3-group design would limit participation. Further, the cost to replicate the in-person program and assure intervention fidelity would have been prohibitive.

We also chose to power the study sample to assure that we would be able to assess the impact of the mediators proposed by our conceptual framework. The study could be conducted with fewer subjects if efficacy of the two interventions was our only aim. Assessment of the mediators will allow us to determine the mechanisms by which the interventions work. This decision does create increased subject burden, due to the number of items on all questionnaires.

Another design consideration was to cross-over subjects at the 12 month data point to allow youth randomized to Managing Diabetes to experience TEENCOPE and vice versa. This approach will allow us to explore whether one of these interventions should precede the other. It does, however, limit our sustainability analyses to 12 months.

In summary, TEENCOPE and Managing Diabetes are internet-based programs that mimic the learning provided in our group-based CST program and educational program for youth with T1D. Provided over the internet, youth will receive standardized content and be able to log-on and participate in the training at their convenience with no burden to clinic resources. Youth will have access to psycho-educational programs as they transition to having more responsibility for their own diabetes management and face the complex social challenges of being an adolescent with T1D. This translational study will provide important insight into the ability of internet programs to reach diverse youth with T1D and the cost-effectiveness of internet programs for youth with T1D which has the potential to lead to the incorporation of such programs into pediatric diabetes practice.