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

Tracking Information

• First Submitted Date: December 13, 2002
• First Posted Date: December 16, 2002
• Last Update Posted Date: May 3, 2012
• Study Start Date: July 2001
• Actual Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 4, 2008): Mood Severity Index [ Time Frame: Measured at Months 6 and 12 ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures (submitted: March 4, 2008): Rage Index (MRS irritability + disruptive-aggressive items) [ Time Frame: Measured at Months 6 and 12 ]
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Family Psychoeducation for Children With Mood Disorders
• Official Title: Family Psychoeducation: Efficacy in Child Mood Disorders
• 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Mood Disorders

Intervention

• 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.

Study Arms

• Experimental: 1
  Participants will receive immediate Multi-Family Psychoeducation Group treatment and ongoing treatment as usual
  Interventions:

  • Behavioral: Multifamily Psychoeducation Group (MFPG)
  • Behavioral: Treatment as usual (TAU)
• Active Comparator: 2
  Participants will receive treatment as usual and waitlist Multi-Family Psychoeducation Group treatment
  Interventions:

  • Behavioral: Multifamily Psychoeducation Group (MFPG)
  • Behavioral: Treatment as usual (TAU)

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 23, 2005): 165
• Original Enrollment: Same as current
• Actual Study Completion Date: December 2006
• Actual Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 8 Years to 11 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00050557
• Other Study ID Numbers: R01MH061512( U.S. NIH Grant/Contract ); R01MH061512 ( U.S. NIH Grant/Contract ); DSIR CT-S
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Mary Fristad, Ohio State University
• Study Sponsor: Mary Fristad
• Collaborators: National Institute of Mental Health (NIMH)

Investigators

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

• PRS Account: Ohio State University
• Verification Date: May 2012