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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, The Ohio State University

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.

Condition or disease Intervention/treatment Phase
Mood Disorders Behavioral: Multifamily Psychoeducation Group (MFPG) Behavioral: Treatment as usual (TAU) Phase 1

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 : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Family Psychoeducation: Efficacy in Child Mood Disorders
Study Start Date : July 2001
Primary Completion Date : September 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mood Disorders
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Mood Severity Index [ Time Frame: Measured at Months 6 and 12 ]

Secondary Outcome Measures :
  1. Rage Index (MRS irritability + disruptive-aggressive items) [ Time Frame: Measured at Months 6 and 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050557


Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Mary Fristad
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Mary A. Fristad, PhD Ohio State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mary Fristad, Professor, Psychiatry, The Ohio State University
ClinicalTrials.gov Identifier: NCT00050557     History of Changes
Other Study ID Numbers: R01MH061512 ( U.S. NIH Grant/Contract )
DSIR CT-S
First Posted: December 16, 2002    Key Record Dates
Last Update Posted: May 3, 2012
Last Verified: May 2012

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