Diabetes Adolescent and Family Group Therapy

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT01626586
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

In this research study the investigators want more about how being in a group about diabetes helps your family versus individual treatment. The investigators are now asking youth with recently diagnosed (\<1 year) diabetes and their parents to be in the research, because the investigators want to see if this diabetes group and/or individual therapy is helpful to your coping, adjustment, and family communication about diabetes.

Detailed Description

The purpose of this research study is to find out what effects the Group Therapy Project has on parents and child's management of Type 1 Diabetes Mellitus (T1DM) from both a group versus an individual therapy modality. We want to start a group and individual therapy program that looks at youth and family adjustment and coping at the Cincinnati Children's Hospital with patients who have T1DM. There has been research before on this group therapy and we want to look at it in a "typical" clinical setting at Cincinnati Children's Hospital for both group and individual therapy, including recently diagnosed patients (\<1 year). This research is being done to understand how a peer and family-based group versus individual therapy can be helpful by looking at survey data as well as medical data before and after participating in the diabetes therapy program. This information will help us further develop prevention and intervention programs for other youth with T1DM and their families.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-25
• Status Verified: 2020-02
• Primary Completion: 2020-02-24
• Study Completion: 2020-02-24
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Diagnosis of Type 1 Diabetes,
• Aged 10.0 - 17.9 years of age,
• At least one parent/caregiver to participate with them,
• Diagnosed for at least 6 months for the Group and the Individual Arms.
• Diagnosed for <1 year for the Recently Diagnosed Arm

Exclusion Criteria

• Potential participants will be excluded if:

  • They have a co-existing diagnosis of mental retardation, pervasive developmental disorder, substance abuse, eating disorders, psychosis, or other acute psychiatric or medical needs, such as suicidality
  • They are not fluent in the English language.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diabetes-related Outcomes	8 years	Diabetes-related improvements for the youths and their parents (e.g., diabetes responsibility, adherence, and parent-child interactions) from baseline to post-treatment, maintenance of these changes over the 2 and 4 month follow-up.

Secondary Outcome Measures

Name	Time	Method
Diabetes-related medical outcome data	8 years	Medical improvements for youth (e.g., HbA1c) pre- to post-treatment and maintained at 6 months after the last booster session. Decreased health care utilization for the youth (e.g., emergency room visits and inpatient hospitalizations) pre- to post-treatment and maintained at 6 months after the last booster session.

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States