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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00684658
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : April 2, 2020
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Yale University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: TeenCope Behavioral: Managing Diabetes Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Internet Coping Skills Training Program for Teens With Type 1 Diabetes
Study Start Date : May 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
TeenCope: Internet-based Coping Skills Training
 Behavioral: TeenCope
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.


Outcome Measures
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Primary Outcome Measures :
  1. Hemoglobin A1c (HbA1c) [ Time Frame: 18 months ]
  2. Pediatric Quality of Life Inventory (PedsQL) [ Time Frame: 18 months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684658


Locations
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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
Sponsors and Collaborators
Yale University
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Margaret Grey, DrPh, FAAN, CPNP Yale School of Nursing
Principal Investigator: Robin Whittemore, PhD, APRN Yale School of Nursing
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00684658    
Other Study ID Numbers: 0711003291
R01NR004009 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2008    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: March 2020
Keywords provided by Yale University:
Type 1 Diabetes
Children and Teenagers
Coping with Chronic Illness
 Adolescence
Internet psychosocial program
Coping Skills Training
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases