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Family Psychoeducation for Children With Mood Disorders
This study is ongoing, but not recruiting participants.
Study NCT00050557   Information provided by National Institute of Mental Health (NIMH)
First Received: December 13, 2002   Last Updated: March 4, 2008   History of Changes

December 13, 2002
March 4, 2008
July 2001
September 2008   (final data collection date for primary outcome measure)
Mood Severity Index [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: Yes ]
Same as current
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 ]
Same as current
 
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.

Phase I
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Mood Disorders
  • Behavioral: Multifamily Psychoeducation Group (MFPG)
  • Behavioral: Treatment as usual (TAU)
  • Experimental: Participants will receive immediate Multi-Family Psychoeducation Group treatment and ongoing treatment as usual
  • Active Comparator: Participants will receive treatment as usual and waitlist Multi-Family Psychoeducation Group treatment
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
165
September 2008
September 2008   (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
Mary A. Fristad, PhD, The Ohio State University Research Foundation
R01 MH61512, DSIR CT-S
National Institute of Mental Health (NIMH)
 
Principal Investigator: Mary A. Fristad, PhD Ohio State University
National Institute of Mental Health (NIMH)
March 2008

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