Family Psychoeducation for Children With Mood Disorders

This study has been completed.
Sponsor:
Collaborator:
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
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Family Psychoeducation: Efficacy in Child Mood Disorders

Resource links provided by NLM:


Further study details as provided by Ohio State University:

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
Study Completion Date: December 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Active Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Mary Fristad
Investigators
Principal Investigator: Mary A. Fristad, PhD Ohio State University
  More Information

No publications provided

Responsible Party: Mary Fristad, Professor, Psychiatry, The Ohio State University
ClinicalTrials.gov Identifier: NCT00050557     History of Changes
Other Study ID Numbers: R01 MH61512, R01MH061512, DSIR CT-S
Study First Received: December 13, 2002
Last Updated: May 2, 2012
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 22, 2014