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Diabetes Adolescent and Family Group Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
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: July 28, 2016
Last verified: July 2016
History of Changes

June 19, 2012
July 28, 2016
May 2012
August 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01626586 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Diabetes Adolescent and Family Group Therapy
Adjustment and Self-Management Intervention Groups for Youth With Type 1 Diabetes Mellitus
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.
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.
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
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.
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
August 2016
August 2016   (final data collection date for primary outcome measure)

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.
Both
10 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01626586
2012-1200
No
Not Provided
Not Provided
Jessica Kichler, Ph.D., C.D.E., Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
Marquette University
Principal Investigator: Jessica Kichler, PhD Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP