Family Psychoeducation for Children With Mood Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2006-12-31

Brief Summary

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The purpose of this study is to evaluate the effectiveness of a Multifamily Psychoeducation Group for the families of children with mood disorders.

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Detailed Description

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Mood disorders among youth are a major health concern. Existing mood disorder studies focus on adults, and studies that focus on effective intervention strategies for youth with mood disorders are needed. This 8-session study is an adjunct to ongoing medication management and individual and family psychotherapy for children with mood disorders.

In this study, parents learn about mood disorders, their treatments, and how to work effectively with mental health and school systems. Parents also practice problem-solving and communication skills for symptom management. Children learn about mood disorders and their treatments, including basic cognitive-behavioral principles. Children also learn and practice anger management, problem-solving, and communication skills.

Patients and their families are randomly assigned to 1 of 2 groups. The first group receives 8 sessions of psychoeducation plus treatment as usual (TAU). The second group is a wait-list control in which participants receive only TAU. Patients and caregivers undergo a variety of interviews, tests, and behavioral observations throughout the study. Anxiety, depression, psychosocial stressors, manic symptoms, and children's experiences with psychotropic medications and with treatment or service providers are assessed. Caregivers, teachers, and family friends undergo interviews and make observations of the patient's level of support, general appearance and behavior, and overall functional capacity. The extent to which caregivers agree on the need for treatment and the extent of caregivers' knowledge of mood disorders is also assessed. Assessments occur at 3, 6, 12, 15, and 18 months after study enrollment. A comprehensive assessment is conducted at study entry and 1 year later.

Conditions

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Mood Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Participants will receive immediate Multi-Family Psychoeducation Group treatment and ongoing treatment as usual

Group Type EXPERIMENTAL

Multifamily Psychoeducation Group (MFPG)

Intervention Type BEHAVIORAL

MFPG will include 8 weekly 90-minute group therapy sessions.

Treatment as usual (TAU)

Intervention Type BEHAVIORAL

Participants will receive standard care for mood disorders.

2

Participants will receive treatment as usual and waitlist Multi-Family Psychoeducation Group treatment

Group Type ACTIVE_COMPARATOR

Multifamily Psychoeducation Group (MFPG)

Intervention Type BEHAVIORAL

MFPG will include 8 weekly 90-minute group therapy sessions.

Treatment as usual (TAU)

Intervention Type BEHAVIORAL

Participants will receive standard care for mood disorders.

Interventions

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Multifamily Psychoeducation Group (MFPG)

MFPG will include 8 weekly 90-minute group therapy sessions.

Intervention Type BEHAVIORAL

Treatment as usual (TAU)

Participants will receive standard care for mood disorders.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Major depressive disorder, dysthymic disorder, or bipolar disorder (Type I or II)
* IQ greater than 70
* At least one parent/caregiver willing to participate in the study
* Able to attend six or more of the eight treatment sessions with at least 1 parent

Minimum Eligible Age

8 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No