Family Psychoeducation for Children With Mood Disorders

Phase 1

Completed

• Conditions: Mood Disorders
• Interventions: Behavioral: Multifamily Psychoeducation Group (MFPG); Behavioral: Treatment as usual (TAU)

• Registration Number: NCT00050557
• Lead Sponsor: Mary Fristad

Brief Summary

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

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 Timeline

• Study Start: 2001-07
• Study First Submitted: 2002-12-13
• Study First Submitted QC: 2002-12-13
• Study First Posted: 2002-12-16
• Primary Completion: 2006-09
• Study Completion: 2006-12
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-02
• Last Update Posted: 2012-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Multifamily Psychoeducation Group (MFPG)	Participants will receive immediate Multi-Family Psychoeducation Group treatment and ongoing treatment as usual
1	Treatment as usual (TAU)	Participants will receive immediate Multi-Family Psychoeducation Group treatment and ongoing treatment as usual
2	Multifamily Psychoeducation Group (MFPG)	Participants will receive treatment as usual and waitlist Multi-Family Psychoeducation Group treatment
2	Treatment as usual (TAU)	Participants will receive treatment as usual and waitlist Multi-Family Psychoeducation Group treatment

Primary Outcome Measures

Name	Time	Method
Mood Severity Index	Measured at Months 6 and 12

Secondary Outcome Measures

Name	Time	Method
Rage Index (MRS irritability + disruptive-aggressive items)	Measured at Months 6 and 12

Trial Locations

Locations (1)

Ohio State University; 🇺🇸 Columbus, Ohio, United States