Intervention Groups for Adolescents With Type 1 Diabetes Mellitus
The purpose of this study is to utilize a group therapy adjustment and coping program at the Children's Hospital of Wisconsin with patients who have Type 1 Diabetes Mellitus (T1DM) and their parents within a "typical" clinical condition of patients who have been referred for outpatient therapy services. To extend the previous literature on these types of peer and family-based groups to include survey data as well as provider ratings, medical data, and add retrospective and prospective data from baseline enrollment. To aid in establishing this group therapy methodology as a "promising" evidence-based intervention within a population of youths with T1DM and their families. The specific aim of this project is to enroll patients and their families into either a treatment group or a wait list control group to receive the group intervention to determine the impact of this peer and family-based group on improving adjustment, coping, and functioning within diabetes.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Adjustment and Self-Management Intervention Groups for Adolescents With Type 1 Diabetes Mellitus and Their Parents.|
- Enroll patients and their families into either a treatment group or a wait list control (WLC) group to determine the impact of a peer and family-based group intervention on improving adjustment, coping, and functioning among adolescents with diabetes. [ Time Frame: Baseline, end of treatment, 4 months post-treatment, and 6 months post treatment ] [ Designated as safety issue: No ]
- Cost-effectiveness will be demonstrated through decreased health care utilization (e.g., emergency room visits, extra outpatient visits, and inpatient hospitalizations). [ Time Frame: 6 months prior to initiating treatment and 6 months after initiating treatment ] [ Designated as safety issue: No ]
- Diabetes-related medical improvements from baseline to post-treatment and maintained at 4 months and 6 months post-treatment. [ Time Frame: baseline, post-treatment, 4 months and 6 months post-treatment. ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Wait List Control
Patients and their families will be enrolled into either a treatment group or a wait list control (WLC) group to receive the group therapy intervention.
Behavioral: Group Therapy
Self-management Group Protocol: The parent sessions will be structured by general topic area, but teaching of clinical and behavioral information will be derived from questions and problems posed by the group in order to actively meet the needs and concerns of participants. The parent sessions will be an interactive process of eliciting concerns and questions, presenting information to address those questions, and following up with a discussion to review concerns and strategies to address the behavioral aspects of the issues. The child sessions will be activity focused, with hands-on opportunities to practice the skills being taught.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00622271
|United States, Wisconsin|
|Children's Hospital of Wisconsin Child and Adolescent Psychiatry and Behavioral Medicine Center and the Diabetes Clinic|
|Milwaukee, Wisconsin, United States, 53201|
|Principal Investigator:||Jessica C Kichler, Ph.D.||Children's Hospital and Health System Foundation, Wisconsin|