Teens-Connect: Preventive Psycho-education for Transitioning Teens With Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the use of a state-of the art internet psycho-educational program in clinical practice (Teens-Connect), compared to use of a standard and widely available internet diabetes program for youth (Planet D™) in a mixed-method randomized clinical trial design.

Detailed Description
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The aims are: To evaluate the efficacy and cost-effectiveness of provider-prescribed Teens-Connect (TEENCOPE™+Managing Diabetes) in pediatric diabetes practice compared to prescription of Planet D™. The hypotheses to be studied are: Youth who participate in Teens-Connect will have better metabolic control (A1c) and quality of life (QOL) than those who participate in Planet D. These effects will be mediated by improvements in stress/coping, self-efficacy, diabetes problem-solving, and self-management. Teens-Connect prescribed by providers in diabetes clinics will be a cost-effective approach to reduce A1c and improve quality-adjusted life years (QALYs) for youth with T1D. To compare the reach, efficacy, adoption, implementation, and maintenance (RE-AIM) of the two provider-prescribed psycho-educational internet programs.

Official Title
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Teens-Connect: Preventive Psycho-education for Transitioning Teens With Diabetes

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Behavioral: Teens-Connect
* Behavioral: Planet D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with type 1 diabetes for at least 6 months Age 11 to 14 years English-speaking Assent Parent/guardian consent to participate in study Exclusion Criteria: *Previous exposure to TEENCOPE and/or Managing Diabetes

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teens-Connect<br>The Teens-Connect Program is an internet-based program that combines Managing Diabetes and TEENCOPE. | Behavioral: Teens-Connect<br>* Teens-Connect combines Managing Diabetes and TEENCOPE. Managing Diabetes consists of 5 sessions on age-appropriate, educational content related to diabetes problem-solving and self-efficacy to improve self-management. TEENCOPE consists of 5 sessions designed to increase youth's sense of competence and mastery by retraining inappropriate or non-constructive coping styles and forming more positive styles and patterns of behavior. The program is highly interactive and youth can talk with each other on an online moderated discussion board. Youth will be asked to use the website at least twice per week for 4 weeks.<br>|
| Active Comparator: Planet D<br>Planet D is an internet program developed by the American Diabetes Association for children and adolescents with diabetes. | Behavioral: Planet D<br>* Planet D provides age-appropriate diabetes education on a variety of topics and social networking discussion boards on diabetes, food and exercise, personal interests, and diabetes camp. Planet D addresses emotions and self-management through education and social networking. Youth who register can also create a profile, upload and share pictures, identify favorite news and blog feeds as well as provide comments or tags to other members. Planet D has been online since 2007 and contains numerous diabetes-related articles geared toward youth as well as a secure message board. Youth will be asked to interact with the website twice a week for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline hemoglobin A1c over 12 months |  | Baseline, 6 weeks, 6 months, 12 months | 
| Change from baseline quality of life over 12 months |  | Baseline, 6 weeks, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline coping/Stress over 12 months | Coping/stress will be measured using the Perceived Stress Scale | Baseline, 6 weeks, 6 months, 12 months | 
| Change from baseline self-efficacy over 12 months | Self-efficacy will be assessed using the Self-efficacy for Diabetes Scale | Baseline, 6 weeks, 6 months, 12 months | 
| Change from baseline problem-solving over 12 months | Problem-solving will be assessed using the Self-Management of Diabetes-Adolescent (SMOD-A) questionnaire | Baseline, 6 weeks, 6 months, 12 months | 
| Change from baseline self-management over 12 months | Self-management will be assessed using the Self-care Inventory (SCI) | Baseline, 6 weeks, 6 months, 12 months | 
| Costs | Costs will be assessed using financial and staff records | 6 months | 
| Change from baseline quality adjusted life years over 12 months | Quality adjusted life years will be assessed using the Health Utilities Index Step 3 (Adolescent and Parent) | Baseline, 6 weeks, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 1, Self care, Coping skills, Adolescent, Internet, Intervention Studies, Chronic Disease