NCT00050557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2001

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 16, 2002

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

May 3, 2012

Status Verified

May 1, 2012

Enrollment Period

5.2 years

First QC Date

December 13, 2002

Last Update Submit

May 2, 2012

Conditions

Mood Disorders

Outcome Measures

Primary Outcomes (1)

  • Mood Severity Index

    Measured at Months 6 and 12

Secondary Outcomes (1)

  • Rage Index (MRS irritability + disruptive-aggressive items)

    Measured at Months 6 and 12

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: Multifamily Psychoeducation Group (MFPG)Behavioral: Treatment as usual (TAU)

2

ACTIVE COMPARATOR

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

Behavioral: Multifamily Psychoeducation Group (MFPG)Behavioral: Treatment as usual (TAU)

Interventions

Multifamily Psychoeducation Group (MFPG)BEHAVIORAL

MFPG will include 8 weekly 90-minute group therapy sessions.

12
Treatment as usual (TAU)BEHAVIORAL

Participants will receive standard care for mood disorders.

12

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

  • 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.

    PMID: 23800483DERIVED

  • 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.

    PMID: 19736358DERIVED

MeSH Terms

Conditions

Mood Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Mary A. Fristad, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Psychiatry

Study Record Dates

First Submitted

December 13, 2002

First Posted

December 16, 2002

Study Start

July 1, 2001

Primary Completion

September 1, 2006

Study Completion

December 1, 2006

Last Updated

May 3, 2012

Record last verified: 2012-05

Locations

US(1)