Family Psychoeducation for Children With Mood Disorders

May 2, 2012 updated by: Mary Fristad

Family Psychoeducation: Efficacy in Child Mood Disorders

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will receive immediate Multi-Family Psychoeducation Group treatment and ongoing treatment as usual
Behavioral: Multifamily Psychoeducation Group (MFPG)
MFPG will include 8 weekly 90-minute group therapy sessions.
Behavioral: Treatment as usual (TAU)
Participants will receive standard care for mood disorders.
Active Comparator: 2
Participants will receive treatment as usual and waitlist Multi-Family Psychoeducation Group treatment
Behavioral: Multifamily Psychoeducation Group (MFPG)
MFPG will include 8 weekly 90-minute group therapy sessions.
Behavioral: Treatment as usual (TAU)
Participants will receive standard care for mood disorders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mood Severity Index
Time Frame: Measured at Months 6 and 12
Measured at Months 6 and 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Rage Index (MRS irritability + disruptive-aggressive items)
Time Frame: Measured at Months 6 and 12
Measured at Months 6 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mary Fristad

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Mary A. Fristad, PhD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

December 13, 2002

First Submitted That Met QC Criteria

December 13, 2002

First Posted (Estimate)

December 16, 2002

Study Record Updates

Last Update Posted (Estimate)

May 3, 2012

Last Update Submitted That Met QC Criteria

May 2, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH061512 (U.S. NIH Grant/Contract)
  • DSIR CT-S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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