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Family Psychoeducation for Children With Mood Disorders

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Mary Fristad, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00050557
First received: December 13, 2002
Last updated: May 2, 2012
Last verified: May 2012
History of Changes

December 13, 2002
May 2, 2012
July 2001
September 2006   (final data collection date for primary outcome measure)
Mood Severity Index [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00050557 on ClinicalTrials.gov Archive Site
Rage Index (MRS irritability + disruptive-aggressive items) [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Family Psychoeducation for Children With Mood Disorders
Family Psychoeducation: Efficacy in Child Mood Disorders

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

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Mood Disorders
  • 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.
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
December 2006
September 2006   (final data collection date for primary outcome measure)

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
Both
8 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00050557
R01 MH61512, R01MH061512, DSIR CT-S
No
Mary Fristad, The Ohio State University
Mary Fristad
National Institute of Mental Health (NIMH)
Principal Investigator: Mary A. Fristad, PhD Ohio State University
Ohio State University
May 2012

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