Diabetes Adolescent and Family Group Therapy

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Behavioral: Group Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01626586

2012-1200

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 3 patient groups

Group Therapy

Experimental group

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.

Treatment:

Behavioral: Group Therapy

Individual Arm

Active Comparator group

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.

Treatment:

Behavioral: Group Therapy

Recently Diagnosed Arm

Active Comparator group

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.

Treatment:

Behavioral: Group Therapy