Diabetes Adolescent and Family Group Therapy

Tracking Information
First Submitted Date ICMJE	June 19, 2012
First Posted Date ICMJE	June 25, 2012
Last Update Posted Date	June 12, 2018
Actual Study Start Date ICMJE	May 2012
Estimated Primary Completion Date	August 2020 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: February 10, 2017)	Diabetes-related Outcomes [ Time Frame: 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.
Original Primary Outcome Measures ICMJE; (submitted: June 20, 2012)	Diabetes-related Outcomes [ Time Frame: 4 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.
Change History	Complete list of historical versions of study NCT01626586 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: February 10, 2017)	Diabetes-related medical outcome data [ Time Frame: 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.
Original Secondary Outcome Measures ICMJE; (submitted: June 20, 2012)	Diabetes-related medical outcome data [ Time Frame: 4 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.
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Diabetes Adolescent and Family Group Therapy
Official Title ICMJE	Adjustment and Self-Management Intervention Groups for Youth With Type 1 Diabetes Mellitus
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 Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Type 1 Diabetes Mellitus
Intervention ICMJE	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.
Study Arms	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 group 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. Intervention: Behavioral: Group Therapy; Active Comparator: Individual Arm This study includes having an initial assessment completed; participating in a 6 session individual therapy intervention over a 7 week time period; and returning at 2 months after the individual therapy intervention for the "booster" follow-up session. During the individual intervention sessions, the youth and the parents 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. Intervention: Behavioral: Group Therapy; Active Comparator: Recently Diagnosed Arm This study includes enrolling patients with Type 1 Diabetes, who are recently diagnosed (<1 year) to participate in a 4 session group therapy intervention over a 4 week time period; and returning at 2 months after the last group session for the "booster" follow-up session. During the group sessions, the youth and the parents will each meet for about 45 minutes and then the families will come together to work on family goals for the last 15-20 minutes. Intervention: Behavioral: Group Therapy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: June 20, 2012)	80
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	August 2020
Estimated Primary Completion Date	August 2020 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	10 Years to 17 Years (Child)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Jessica Kichler, PhD (414) 636-4336 jessica.kichler@cchmc.org
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01626586
Other Study ID Numbers ICMJE	2012-1200
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Jessica Kichler, Ph.D., C.D.E., Children's Hospital Medical Center, Cincinnati
Study Sponsor ICMJE	Children's Hospital Medical Center, Cincinnati
Collaborators ICMJE	Marquette University
Investigators ICMJE	Principal Investigator: Jessica Kichler, PhD Children's Hospital Medical Center, Cincinnati
PRS Account	Children's Hospital Medical Center, Cincinnati
Verification Date	June 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP