Diabetes Adolescent and Family Group Therapy
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2015 by Children's Hospital Medical Center, Cincinnati
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
ClinicalTrials.gov Identifier:
NCT01626586
First received: June 19, 2012
Last updated: February 2, 2015
Last verified: February 2015
| Tracking Information | |||||
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| First Received Date ICMJE | June 19, 2012 | ||||
| Last Updated Date | February 2, 2015 | ||||
| Start Date ICMJE | May 2012 | ||||
| Estimated Primary Completion Date | August 2016 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| 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: 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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| 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. 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. |
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| 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). 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Type 1 Diabetes Mellitus | ||||
| Intervention ICMJE | 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. |
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| Study Arm (s) | 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.
Intervention: Behavioral: Group Therapy |
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| Publications * | Not Provided | ||||
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* 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 | ||||
| Estimated Completion Date | August 2016 | ||||
| Estimated Primary Completion Date | August 2016 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 10 Years to 17 Years | ||||
| 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 | ||||
| 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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| Information Provided By | Children's Hospital Medical Center, Cincinnati | ||||
| Verification Date | February 2015 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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