Diabetes Group Therapy
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Adjustment and Self-Management Intervention Groups for Youth With Type 1 Diabetes Mellitus|
- Diabetes-related Outcomes [ Time Frame: 4 years ] [ Designated as safety issue: No ]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.
- Diabetes-related medical outcome data [ Time Frame: 4 years ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Experimental: Group Therapy
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.
Behavioral: 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626586
|Contact: Jessica Kichler, PhD||(414) email@example.com|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Jessica Kichler, PhD 414-636-4336 firstname.lastname@example.org|
|Principal Investigator: Jessica Kichler, PhD|
|Sub-Investigator: Lawrence Dolan, MD|
|Sub-Investigator: Astrida Kaugars, PhD|
|Principal Investigator:||Jessica Kichler, PhD||Children's Hospital Medical Center, Cincinnati|