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Diabetes Adolescent and Family Group Therapy

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Therapy
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Youth, Family, Group Therapy, Type 1 Diabetes Mellitus, Self-Management

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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 for the Group and the Individual Arms.
  • Diagnosed for <1 year for the Recently Diagnosed Arm

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.

Sites / Locations

  • Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Group Therapy

Individual Arm

Recently Diagnosed Arm

Arm Description

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.

This study includes having an initial assessment completed; participating in a 6 session individual therapy intervention over a 7 week time period; and returning at 2 months after the individual therapy intervention for the "booster" follow-up session. During the individual intervention sessions, the youth and the parents 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.

This study includes enrolling patients with Type 1 Diabetes, who are recently diagnosed (<1 year) to participate in a 4 session group therapy intervention over a 4 week time period; and returning at 2 months after the last group session for the "booster" follow-up session. During the group sessions, the youth and the parents will each meet for about 45 minutes and then the families will come together to work on family goals for the last 15-20 minutes.

Outcomes

Primary Outcome Measures

Diabetes-related Outcomes
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
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.

Full Information

First Posted
June 19, 2012
Last Updated
February 24, 2020
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Marquette University
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1. Study Identification

Unique Protocol Identification Number
NCT01626586
Brief Title
Diabetes Adolescent and Family Group Therapy
Official Title
Adjustment and Self-Management Intervention Groups for Youth With Type 1 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 2012 (Actual)
Primary Completion Date
February 24, 2020 (Actual)
Study Completion Date
February 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Marquette University

4. Oversight

Data Monitoring Committee
No

5. 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 now asking youth with recently diagnosed (<1 year) 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, including recently diagnosed patients (<1 year). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Youth, Family, Group Therapy, Type 1 Diabetes Mellitus, Self-Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Individual Arm
Arm Type
Active Comparator
Arm Description
This study includes having an initial assessment completed; participating in a 6 session individual therapy intervention over a 7 week time period; and returning at 2 months after the individual therapy intervention for the "booster" follow-up session. During the individual intervention sessions, the youth and the parents 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.
Arm Title
Recently Diagnosed Arm
Arm Type
Active Comparator
Arm Description
This study includes enrolling patients with Type 1 Diabetes, who are recently diagnosed (<1 year) to participate in a 4 session group therapy intervention over a 4 week time period; and returning at 2 months after the last group session for the "booster" follow-up session. During the group sessions, the youth and the parents will each meet for about 45 minutes and then the families will come together to work on family goals for the last 15-20 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Group Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Diabetes-related Outcomes
Description
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.
Time Frame
8 years
Secondary Outcome Measure Information:
Title
Diabetes-related medical outcome data
Description
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.
Time Frame
8 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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 for the Group and the Individual Arms. Diagnosed for <1 year for the Recently Diagnosed Arm 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Kichler, PhD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

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Diabetes Adolescent and Family Group Therapy

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