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

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


Condition Intervention Phase
Mood Disorders
Behavioral: Multifamily Psychoeducation Group (MFPG)
Behavioral: Treatment as usual (TAU)
Phase I

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: Family Psychoeducation: Efficacy in Child Mood Disorders

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Mood Severity Index [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rage Index (MRS irritability + disruptive-aggressive items) [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: Yes ]

Enrollment: 165
Study Start Date: July 2001
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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.
2: Active Comparator
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.

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.

  Eligibility

Ages Eligible for Study:   8 Years to 11 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050557

Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Investigators
Principal Investigator: Mary A. Fristad, PhD Ohio State University
  More Information

No publications provided

Responsible Party: The Ohio State University Research Foundation ( Mary A. Fristad, PhD )
Study ID Numbers: R01 MH61512, DSIR CT-S
Study First Received: December 13, 2002
Last Updated: March 4, 2008
ClinicalTrials.gov Identifier: NCT00050557     History of Changes
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Pathologic Processes
Disease
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on February 04, 2010