TEENCOPE: An Internet Coping Skills Training Program for Teens With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      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: 
      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.
    

Intervention name(s): TeenCope; Managing Diabetes
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 1 Diabetes; Children and Teenagers; Coping with Chronic Illness; Adolescence; Internet psychosocial program; Coping Skills Training