Type 1 Diabetes Clinical Trial
Official title:
An Internet Coping Skills Training Program for Teens With Type 1 Diabetes
Verified date | March 2020 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 320 |
Est. completion date | May 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 11 Years to 14 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Miami | Miami | Florida |
United States | Yale University School of Nursing | New Haven | Connecticut |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | University of Arizona | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute of Nursing Research (NINR) |
United States,
Grey M, Boland EA, Davidson M, Li J, Tamborlane WV. Coping skills training for youth with diabetes mellitus has long-lasting effects on metabolic control and quality of life. J Pediatr. 2000 Jul;137(1):107-13. — View Citation
Grey M, Boland EA, Davidson M, Yu C, Sullivan-Bolyai S, Tamborlane WV. Short-term effects of coping skills training as adjunct to intensive therapy in adolescents. Diabetes Care. 1998 Jun;21(6):902-8. — View Citation
Grey M, Whittemore R, Liberti L, Delamater A, Murphy K, Faulkner MS. A comparison of two internet programs for adolescents with type 1 diabetes: design and methods. Contemp Clin Trials. 2012 Jul;33(4):769-76. doi: 10.1016/j.cct.2012.03.012. Epub 2012 Mar 29. — View Citation
Whittemore R, Grey M, Lindemann E, Ambrosino J, Jaser S. Development of an Internet coping skills training program for teenagers with type 1 diabetes. Comput Inform Nurs. 2010 Mar-Apr;28(2):103-11. doi: 10.1097/NCN.0b013e3181cd8199. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hemoglobin A1c (HbA1c) | 18 months | ||
Primary | Pediatric Quality of Life Inventory (PedsQL) | 18 months | ||
Secondary | Perceived Stress Scale (PSS) | 18 months | ||
Secondary | Self-Efficacy for Diabetes Scale | 18 months | ||
Secondary | Children's Depression Inventory | 18 months | ||
Secondary | Self-Perception Profile for Adolescents | 18 months | ||
Secondary | Responses to Stress Questionaire (RSQ) | 18 months | ||
Secondary | Diabetes Family Behavior Scale | 18 months | ||
Secondary | Self Management of Type 1 Diabetes | 18 months | ||
Secondary | Diabetes Conflict | 18 months |
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