Diabetes Adolescent and Family Group Therapy
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ClinicalTrials.gov Identifier: NCT01626586 |
Recruitment Status
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Recruiting
First Posted
: June 25, 2012
Last Update Posted
: February 13, 2017
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Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborator:
Marquette University
Information provided by (Responsible Party):
Jessica Kichler, Ph.D., C.D.E., Children's Hospital Medical Center, Cincinnati
Tracking Information | |||||
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First Submitted Date ICMJE | June 19, 2012 | ||||
First Posted Date ICMJE | June 25, 2012 | ||||
Last Update Posted Date | February 13, 2017 | ||||
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 |
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.
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Original Primary Outcome Measures ICMJE |
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.
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Change History | Complete list of historical versions of study NCT01626586 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE |
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.
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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 asking youth with 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. 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 |
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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. |
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Study Arms |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 10 Years to 17 Years (Child) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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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 |
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PRS Account | Children's Hospital Medical Center, Cincinnati | ||||
Verification Date | February 2017 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |