Diabetes Adolescent and Family Group Therapy

NCT ID: NCT01626586

Last Updated: 2020-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2020-02-24

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Group Therapy

Intervention Type: BEHAVIORAL

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.

Individual Arm

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.

Group Type: ACTIVE_COMPARATOR

Group Therapy

Intervention Type: BEHAVIORAL

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.

Recently Diagnosed Arm

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.

Group Type: ACTIVE_COMPARATOR

Group Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marquette University

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Jessica Kichler, Ph.D., C.D.E.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica Kichler, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2012-1200

Identifier Type: -

Identifier Source: org_study_id