Diabetes Adolescent and Family Group Therapy

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Adjustment and Self-Management Intervention Groups for Youth With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626586
• Other study ID #: 2012-1200
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: February 24, 2020

Study information

• Verified date: February 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: February 24, 2020
• Est. primary completion date: February 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• Group Therapy
Self-management Diabetes Protocol: Successful adjustment to daily diabetes management requires a wealth of clinical knowledge, solid problem-solving and coping skills to deal with the physical, social and emotional factors associated with caring for and living with a chronic illness, and motivation to take care of one's health.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Marquette University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes-related Outcomes	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.	8 years
Secondary	Diabetes-related medical outcome data	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.	8 years