TEENCOPE: An Internet Coping Skills Training Program for Teens With Type 1 Diabetes

Study Overview
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Brief Summary
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The purpose of the study is to compare the effects of a 5-week internet-based coping skills training program (TeenCope) with a 5-week internet education program (Managing Diabetes) in youth (age 11-14) with type 1 diabetes on intensive insulin therapy.

Detailed Description
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It is well established that for many youth with type 1 diabetes (T1D), the developmental stage of puberty is characterized by a significant deterioration in metabolic control. Previous research conducted by the Yale School of Nursing demonstrates that providing cognitive-behavioral coping skills training program (CST) as a supplement to intensive medical treatment regimen enhances physiological and psychosocial outcomes - most notably in youth as they approach adolescence. Successful CST programs studied at Yale consist of weekly, in-person group sessions over a 5-week period conducted by a clinical psychologist or social worker. Rapid advances in technology have made the internet a compelling tool to reach out to youth and significantly broaden the application of CST programs. Investigators at Yale (scientists, NPs, clinical psychologists) have teamed with web specialists (computer programmers, web designers, graphic artists, and illustrators) and youth with T1D and their parents to adapt the successful CST program for use on the internet. In this trial, internet-based CST (TeenCope) will be evaluated by comparing it to an internet-based education program for managing diabetes (Managing Diabetes). Three hundred (300) youth from 4 different sites within the U.S will take part in the study. Youth will be randomly assigned to complete either the TeenCope or Managing Diabetes program right away, and will be given the opportunity to complete the alternate program after 12 months. Data on psychosocial and disease management parameters will be collected at baseline, 3, 6, 12 and 18 months through youth filling out online questionnaires (lasting approximately 30 minutes). Clinical outcome data (height, weight, HbA1c, episodes of hypoglycemia, DKA, and hospitalization) will be collected from the medical chart throughout the study, and parents will complete a demographic data form. This study has great potential for working with youth with type 1 diabetes. If proven effective, the investigators are interested in continued dissemination and translation of this intervention beyond their geographical location.

Official Title
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An Internet Coping Skills Training Program for Teens With Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: TeenCope
* Behavioral: Managing Diabetes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 11-14 English speaking Youth assents and parent consents to participation School grade is appropriate to age within 1 year Type 1 diabetes for a minimum of 6 months Access to high speed internet service for 5 week intervention (will be arranged by study if not presently in the home) Exclusion Criteria: Other significant chronic health problems requiring intensive self-management Previous exposure to Yale School of Nursing's Coping Skills Training or Managing Diabetes materials

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>TeenCope: Internet-based Coping Skills Training | Behavioral: TeenCope<br>* Teencope consists of a series of 5 sessions designed to increase children's sense of competence and mastery by retraining inappropriate or non-constructive coping styles and forming more positive styles and patterns of behavior. Each week a new 30-45 minute session is uploaded to a password-protected website on the Yale server for youth to complete. Youth are grouped with 8-12 peers who complete the same weekly sessions in an asynchronous manner. Youth interact with each other on an online discussion board moderated by a clinical psychologist<br>|
| Active Comparator: 2<br>Managing Diabetes: Internet-based Diabetes Education | Behavioral: Managing Diabetes<br>* Managing Diabetes consists of 5 sessions on educational content related to diabetes self management targeted to adolescents. As with the TeenCope program, each week a new 30-45 minute session is uploaded to a password-protected website on the Yale server for youth to complete. Youth complete educational sessions independently over 5 weeks. There is no online discussion board or peer interaction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c (HbA1c) |  | 18 months | 
| Pediatric Quality of Life Inventory (PedsQL) |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress Scale (PSS) |  | 18 months | 
| Self-Efficacy for Diabetes Scale |  | 18 months | 
| Children's Depression Inventory |  | 18 months | 
| Self-Perception Profile for Adolescents |  | 18 months | 
| Responses to Stress Questionaire (RSQ) |  | 18 months | 
| Diabetes Family Behavior Scale |  | 18 months | 
| Self Management of Type 1 Diabetes |  | 18 months | 
| Diabetes Conflict |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, Children and Teenagers, Coping with Chronic Illness, Adolescence, Internet psychosocial program, Coping Skills Training