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Intervention Groups for Adolescents With Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jessica C. Kichler, Children's Hospital and Health System Foundation, Wisconsin
ClinicalTrials.gov Identifier:
NCT00622271
First received: February 14, 2008
Last updated: November 16, 2011
Last verified: November 2011
History of Changes
  Purpose

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
Type 1 Diabetes Mellitus
 Behavioral: Group Therapy

Study Type: Interventional
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital and Health System Foundation, Wisconsin:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: February 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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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  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have been referred for outpatient therapy services will be included if they have Type 1 Diabetes and are 13-17 years of age.

Exclusion Criteria:

  • Potential participants will be excluded if they have the following co-existing diagnoses: mental retardation, pervasive developmental disorders, substance abuse, eating disorders, psychosis, other acute psychiatric or medical needs, such as suicidality.
  • Potential participants will be excluded if they are not fluent in the English language.
  • If a family is not eligible or declines to participate in the group therapy research, they will be referred for individual therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00622271

Locations
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
Sponsors and Collaborators
Children's Hospital and Health System Foundation, Wisconsin
Investigators
Principal Investigator: Jessica C Kichler, Ph.D. Children's Hospital and Health System Foundation, Wisconsin
  More Information

No publications provided

Responsible Party: Jessica C. Kichler, Psychologist, Children's Hospital and Health System Foundation, Wisconsin
ClinicalTrials.gov Identifier: NCT00622271     History of Changes
Other Study ID Numbers: GTP1
Study First Received: February 14, 2008
Last Updated: November 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital and Health System Foundation, Wisconsin:
Type 1 Diabetes Mellitus
Adolescents and Families
Group Therapy Intervention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013