Prevention of Self-care Deterioration in Early Adolescents With Diabetes
|ClinicalTrials.gov Identifier: NCT00890331|
Recruitment Status : Completed
First Posted : April 29, 2009
Last Update Posted : January 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Behavioral: TeamWork CS Sessions Behavioral: Diabetes Education||Phase 1|
Promotion of optimal disease care and metabolic control in youth with Type 1 diabetes is an important goal of disease management during early adolescence. Typically youth assume increasing responsibility for these goals along with parental involvement and guidance. However, as youth progress through adolescence, parents often become less involved in diabetes management and poorer self-care and metabolic control often results.
The goal of the prevention program is to encourage parents to remain involved in their child's diabetes care throughout adolescence and to provide tools to help make that involvement a positive experience. To minimize parent/child conflict that may accompany sustained parental involvement, sessions of the active treatment review the following coping skills: communication, problem solving, conflict resolution, attitude and behavior change. Meetings occur in-clinic in conjunction with four consecutive medical appointments.
The educational comparison group also meets with study researchers for in-clinic sessions that occur in conjunction with four consecutive medical appointments. Families discuss a variety of helpful educational diabetes topics and resources.
The overarching project goal is to demonstrate the efficacy of a brief, prevention focused coping skills program for youth with type 1 diabetes and their parents with the ultimate goal of translation into routine pediatric care.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||285 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Family Teamwork and Coping Skills Prevention Program|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
|Active Comparator: Diabetes Education||
Behavioral: Diabetes Education
Diabetes Education The education comparison group meets with an educational interventionist in conjunction with four consecutive medical appointments. This group focuses on diabetes educational and resource support for parents and their youth with type 1 diabetes.
|Experimental: TeamWork CS Sessions||
Behavioral: TeamWork CS Sessions
The intervention focuses on an authoritative parenting approach that emphasizes continued parental involvement in daily disease care. Dyadic coping skills of communication, problem solving, conflict resolution, along with attitude and behavior change are highlighted. Families meet with a study interventionist in conjunction with four consecutive medical appointments.
- Parental involvement and Disease care behaviors [ Time Frame: Baseline, (optional 3, 6, and 9 months) 12, 15, 18 and 24 months ]
- Glycohemoglobin levels, Adverse effects and Blood glucose variability [ Time Frame: Baseline, 3, 6, 9, 12, 15, 18, and 24 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00890331
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010|
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23284|
|Principal Investigator:||Clarissa S Holmes, Ph.D.||Virginia Commonwealth University|
|Principal Investigator:||Randi Streisand, Ph.D.||Children's Research Institute|
|Study Director:||Rusan Chen, Ph.D.||Georgetown University|