Intervention Groups for Adolescents With Type 1 Diabetes Mellitus

NCT00622271 | Completed

• 1 other identifier: GTP1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes Mellitus; Adolescents and Families; Group Therapy Intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, end of treatment, 4 months post-treatment, and 6 months post treatment

Secondary Outcomes (2)

• Cost-effectiveness will be demonstrated through decreased health care utilization (e.g., emergency room visits, extra outpatient visits, and inpatient hospitalizations).

  6 months prior to initiating treatment and 6 months after initiating treatment

• Diabetes-related medical improvements from baseline to post-treatment and maintained at 4 months and 6 months post-treatment.

  baseline, post-treatment, 4 months and 6 months post-treatment.

Study Arms (1)

Wait List Control

OTHER

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

Interventions

Group Therapy BEHAVIORAL

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.

Wait List Control

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital and Health System Foundation, Wisconsin: lead

Study Sites (1)

Children's Hospital of Wisconsin Child and Adolescent Psychiatry and Behavioral Medicine Center and the Diabetes Clinic

Milwaukee, Wisconsin, 53201, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jessica C Kichler, Ph.D.

  Children's Hospital and Health System Foundation, Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 25, 2008
• Study Start: February 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: November 17, 2011

Record last verified: 2011-11

Locations

US (1)