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Diabetes Adolescent and Family Group Therapy

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ClinicalTrials.gov Identifier: NCT01626586
Recruitment Status : Recruiting
First Posted : June 25, 2012
Last Update Posted : February 13, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Behavioral: Group Therapy

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjustment and Self-Management Intervention Groups for Youth With Type 1 Diabetes Mellitus
Actual Study Start Date : May 2012
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
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.
Active Comparator: Individual Arm
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 months after the individual therapy intervention for "booster" follow-up sessions and returning at only 2 months after the individual therapy intervention for the "booster" follow-up session. During the individual intervention sessions, the youth and the therapy 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 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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017

Keywords provided by Jessica Kichler, Ph.D., C.D.E., 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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases