Diabetes Group Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Children's Hospital Medical Center, Cincinnati
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: June 20, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Type 1 Diabetes Mellitus
Behavioral: Group Therapy

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
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)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626586

Contacts
Contact: Jessica Kichler, PhD (414) 636-4336 jessica.kichler@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Jessica Kichler, PhD    414-636-4336    jessica.kichler@cchmc.org   
Principal Investigator: Jessica Kichler, PhD         
Sub-Investigator: Lawrence Dolan, MD         
Sub-Investigator: Astrida Kaugars, PhD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Marquette University
Investigators
Principal Investigator: Jessica Kichler, PhD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Jessica Kichler, Ph.D., C.D.E., Principal Investigator, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01626586     History of Changes
Other Study ID Numbers: 2012-1200
Study First Received: June 19, 2012
Last Updated: June 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Youth
Family
Group Therapy
Type 1 Diabetes Mellitus
Self-Management

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014