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Sponsored by: |
Children's Hospital and Health System Foundation, Wisconsin |
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Information provided by: | Children's Hospital and Health System Foundation, Wisconsin |
ClinicalTrials.gov Identifier: | NCT00622271 |
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.
Condition | Intervention |
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Type 1 Diabetes Mellitus |
Behavioral: Group Therapy |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Adjustment and Self-Management Intervention Groups for Adolescents With Type 1 Diabetes Mellitus and Their Parents. |
Estimated Enrollment: | 40 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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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.
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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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Ages Eligible for Study: | 13 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jessica C Kichler, PhD | (414) 266-3761 | jkichler@chw.org |
Contact: Astrida S Kaugars, PhD | (414) 688-8592 | astrida.kaugars@marquette.edu |
United States, Wisconsin | |
Children's Hospital of Wisconsin Child and Adolescent Psychiatry and Behavioral Medicine Center and the Diabetes Clinic | Recruiting |
Milwaukee, Wisconsin, United States, 53201 | |
Contact: Jessica C Kichler, PhD 414-266-3761 jkichler@chw.org | |
Contact: Astrida S Kaugars, PhD (414) 288-3665 astrida.kaugars@marquette.edu | |
Sub-Investigator: Astrida S Kaugars, PhD | |
Sub-Investigator: Ramin Alemzadeh, MD | |
Sub-Investigator: Patricia Marik, PhD |
Principal Investigator: | Jessica C Kichler, Ph.D. | Children's Hospital and Health System Foundation, Wisconsin |
Responsible Party: | Children's Hospital of Wisconsin ( Jessica C. Kichler, Ph.D. ) |
Study ID Numbers: | GTP1 |
Study First Received: | February 14, 2008 |
Last Updated: | April 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00622271 |
Health Authority: | United States: Institutional Review Board |
Type 1 Diabetes Mellitus Adolescents and Families Group Therapy Intervention |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Immune System Diseases |