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Completed

NCT Number: NCT00684658

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.

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Key information

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Arizona, Tucson, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TeenCope

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Hemoglobin A1c (HbA1c)

    Time frame: 18 months

  2. Pediatric Quality of Life Inventory (PedsQL)

    Time frame: 18 months

Secondary outcomes

  1. Perceived Stress Scale (PSS)

    Time frame: 18 months

  2. Self-Efficacy for Diabetes Scale

    Time frame: 18 months

  3. Children's Depression Inventory

    Time frame: 18 months

  4. Self-Perception Profile for Adolescents

    Time frame: 18 months

  5. Responses to Stress Questionaire (RSQ)

    Time frame: 18 months

  6. Diabetes Family Behavior Scale

    Time frame: 18 months

  7. Self Management of Type 1 Diabetes

    Time frame: 18 months

  8. Diabetes Conflict

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
May 26, 2008
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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