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TEENCOPE: An Internet Coping Skills Training Program for Teens With Type 1 Diabetes
This study is currently recruiting participants.
Study NCT00684658   Information provided by National Institute of Nursing Research (NINR)
First Received: May 21, 2008   Last Updated: July 13, 2009   History of Changes

May 21, 2008
July 13, 2009
May 2008
May 2012   (final data collection date for primary outcome measure)
  • 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 ]
  • Diabetes Family Conflict Scale [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00684658 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
TEENCOPE: An Internet Coping Skills Training Program for Teens With Type 1 Diabetes
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.

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.

Phase III
Interventional
Other, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Type 1 Diabetes
  • Behavioral: TeenCope
  • Behavioral: Managing Diabetes
  • Experimental: Internet-based Coping Skills Training
  • Active Comparator: Internet-based Diabetes Education

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
300
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
11 Years to 14 Years
No
Contact: Lauren Liberti, MS 203-737-5437 lauren.liberti@yale.edu
United States
 
NCT00684658
Lauren Liberti, MS, TeenCope Trial Coordinator, Yale University School of Nursing
R01NR004009, R01 NR004009
National Institute of Nursing Research (NINR)
 
Principal Investigator: Margaret Grey, DrPh, FAAN, CPNP Yale School of Nursing
Principal Investigator: Robin Whittemore, PhD, APRN Yale School of Nursing
National Institute of Nursing Research (NINR)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP