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Family Psychoeducation for Children With Mood Disorders

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

Tracking Information
First Submitted Date  ICMJE December 13, 2002
First Posted Date  ICMJE December 16, 2002
Last Update Posted Date May 3, 2012
Study Start Date  ICMJE July 2001
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2008)
Mood Severity Index [ Time Frame: Measured at Months 6 and 12 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2008)
Rage Index (MRS irritability + disruptive-aggressive items) [ Time Frame: Measured at Months 6 and 12 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Family Psychoeducation for Children With Mood Disorders
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Mood Disorders
Intervention  ICMJE
  • 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2005)
165
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00050557
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Mary Fristad, Ohio State University
Study Sponsor  ICMJE Mary Fristad
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Mary A. Fristad, PhD Ohio State University
PRS Account Ohio State University
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP