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Family Psychoeducation for Children With Mood Disorders

Primary Purpose

Mood Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Multifamily Psychoeducation Group (MFPG)
Treatment as usual (TAU)
Sponsored by
Mary Fristad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mood Disorders

Eligibility Criteria

8 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will receive immediate Multi-Family Psychoeducation Group treatment and ongoing treatment as usual

Participants will receive treatment as usual and waitlist Multi-Family Psychoeducation Group treatment

Outcomes

Primary Outcome Measures

Mood Severity Index

Secondary Outcome Measures

Rage Index (MRS irritability + disruptive-aggressive items)

Full Information

First Posted
December 13, 2002
Last Updated
May 2, 2012
Sponsor
Mary Fristad
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00050557
Brief Title
Family Psychoeducation for Children With Mood Disorders
Official Title
Family Psychoeducation: Efficacy in Child Mood Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mary Fristad
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive immediate Multi-Family Psychoeducation Group treatment and ongoing treatment as usual
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will receive treatment as usual and waitlist Multi-Family Psychoeducation Group treatment
Intervention Type
Behavioral
Intervention Name(s)
Multifamily Psychoeducation Group (MFPG)
Intervention Description
MFPG will include 8 weekly 90-minute group therapy sessions.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
Participants will receive standard care for mood disorders.
Primary Outcome Measure Information:
Title
Mood Severity Index
Time Frame
Measured at Months 6 and 12
Secondary Outcome Measure Information:
Title
Rage Index (MRS irritability + disruptive-aggressive items)
Time Frame
Measured at Months 6 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary A. Fristad, PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23800483
Citation
Boylan K, Macpherson HA, Fristad MA. Examination of disruptive behavior outcomes and moderation in a randomized psychotherapy trial for mood disorders. J Am Acad Child Adolesc Psychiatry. 2013 Jul;52(7):699-708. doi: 10.1016/j.jaac.2013.04.014.
Results Reference
derived
PubMed Identifier
19736358
Citation
Fristad MA, Verducci JS, Walters K, Young ME. Impact of multifamily psychoeducational psychotherapy in treating children aged 8 to 12 years with mood disorders. Arch Gen Psychiatry. 2009 Sep;66(9):1013-21. doi: 10.1001/archgenpsychiatry.2009.112.
Results Reference
derived

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Family Psychoeducation for Children With Mood Disorders

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