This trial is active, not recruiting.

Condition type 1 diabetes mellitus
Treatment group therapy
Sponsor Children's Hospital Medical Center, Cincinnati
Collaborator Marquette University
Start date May 2012
End date August 2016
Trial size 80 participants
Trial identifier NCT01626586, 2012-1200


In this research study the investigators want more about how being in a group about diabetes helps your family. The investigators are asking youth with diabetes and their parents to be in the research, because the investigators want to see if this diabetes group therapy is helpful to your coping, adjustment, and family communication about diabetes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
This study includes having an initial assessment completed; participating in a 6 session group therapy intervention over a 7 week time period; and returning at 2 and 4 months after group therapy intervention for "booster" follow-up sessions. During the intervention sessions, the parent group and the youth group will each meet for about 45 minutes and then the families will come together to work on family goals for the last 15 to 20 minutes.
group therapy
Self-management Group 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.

Primary Outcomes

Diabetes-related Outcomes
time frame: 4 years

Secondary Outcomes

Diabetes-related medical outcome data
time frame: 4 years

Eligibility Criteria

Male or female participants from 10 years up to 17 years old.

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. 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.

Additional Information

Official title Adjustment and Self-Management Intervention Groups for Youth With Type 1 Diabetes Mellitus
Principal investigator Jessica Kichler, PhD
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). We want to start a group 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. This research is being done to understand how a peer and family-based group can be helpful by looking at survey data as well as medical data before and after participating in the group therapy program. This information will help us further develop prevention and intervention programs for other youth with T1DM and their families.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati.