TEENCOPE: An Internet Coping Skills Training Program for Teens With Type 1 Diabetes
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.
Type 1 Diabetes
Behavioral: Managing Diabetes
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||An Internet Coping Skills Training Program for Teens With Type 1 Diabetes|
- Hemoglobin A1c (HbA1c) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Perceived Stress Scale (PSS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Self-Efficacy for Diabetes Scale [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Children's Depression Inventory [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Self-Perception Profile for Adolescents [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Responses to Stress Questionaire (RSQ) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Diabetes Family Behavior Scale [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Self Management of Type 1 Diabetes [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Diabetes Conflict [ Time Frame: 18 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2008|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
TeenCope: Internet-based Coping Skills Training
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
Active Comparator: 2
Managing Diabetes: Internet-based Diabetes Education
Behavioral: Managing Diabetes
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684658
|United States, Arizona|
|University of Arizona|
|Tucson, Arizona, United States, 85721|
|United States, Connecticut|
|Yale University School of Nursing|
|New Haven, Connecticut, United States, 06519|
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Margaret Grey, DrPh, FAAN, CPNP||Yale School of Nursing|
|Principal Investigator:||Robin Whittemore, PhD, APRN||Yale School of Nursing|