Family Psychoeducation for Children With Mood Disorders

Mood Disorders Clinical Trial

Official title:

Family Psychoeducation: Efficacy in Child Mood Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050557
• Other study ID #: R01MH061512
• Secondary ID: R01MH061512DSIR
• Status: Completed
• Phase: Phase 1
• First received: December 13, 2002
• Last updated: May 2, 2012
• Start date: July 2001
• Est. completion date: December 2006

Study information

• Verified date: May 2012
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: December 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 11 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mood Disorders

Intervention

Behavioral:
• Multifamily Psychoeducation Group (MFPG)
MFPG will include 8 weekly 90-minute group therapy sessions.
• Treatment as usual (TAU)
Participants will receive standard care for mood disorders.

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Mary Fristad	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mood Severity Index		Measured at Months 6 and 12	Yes
Secondary	Rage Index (MRS irritability + disruptive-aggressive items)		Measured at Months 6 and 12	Yes