Family Psychoeducation for Children With Mood Disorders

• ClinicalTrials.gov Identifier: NCT00050557
• Recruitment Status: Completed
• First Posted: December 16, 2002
• Last Update Posted: May 3, 2012
• Sponsor: Mary Fristad
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Mary Fristad, Ohio State University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Mood Disorders	Behavioral: Multifamily Psychoeducation Group (MFPG); Behavioral: Treatment as usual (TAU)	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 165 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Family Psychoeducation: Efficacy in Child Mood Disorders
• Study Start Date: July 2001
• Actual Primary Completion Date: September 2006
• Actual Study Completion Date: December 2006

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Mood Severity Index [ Time Frame: Measured at Months 6 and 12 ]

Secondary Outcome Measures :

1. Rage Index (MRS irritability + disruptive-aggressive items) [ Time Frame: Measured at Months 6 and 12 ]

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 11 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Ohio

Ohio State University

Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Mary Fristad

National Institute of Mental Health (NIMH)

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Boylan K, Macpherson HA, Fristad MA. Examination of disruptive behavior outcomes and moderation in a randomized psychotherapy trial for mood disorders. J Am Acad Child Adolesc Psychiatry. 2013 Jul;52(7):699-708. doi: 10.1016/j.jaac.2013.04.014.

Fristad MA, Verducci JS, Walters K, Young ME. Impact of multifamily psychoeducational psychotherapy in treating children aged 8 to 12 years with mood disorders. Arch Gen Psychiatry. 2009 Sep;66(9):1013-21. doi: 10.1001/archgenpsychiatry.2009.112.

• Responsible Party: Mary Fristad, Professor, Psychiatry, Ohio State University
• ClinicalTrials.gov Identifier: NCT00050557
• Other Study ID Numbers: R01MH061512 ( U.S. NIH Grant/Contract ); R01MH061512 ( U.S. NIH Grant/Contract ); DSIR CT-S
• First Posted: December 16, 2002
• Last Update Posted: May 3, 2012
• Last Verified: May 2012

Additional relevant MeSH terms:

Mood Disorders; Mental Disorders