NCT00404911

Brief Summary

This study will examine the effectiveness of a multiple family group mental health service delivery strategy in improving mental health service use and outcome for urban, low income children of color, ages 7-11 years old with disruptive behaviors and their families.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
416

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2006

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

Enrollment Period

6.3 years

First QC Date

November 28, 2006

Last Update Submit

June 21, 2013

Conditions

Oppositional Defiant DisorderConduct Disorder

Keywords

Oppositional Defiant Disorder

Outcome Measures

Primary Outcomes (2)

  • Youth externalizing behaviors and functioning

    Measured at week 16 of treatment

  • Youth externalizing behaviors and functioning

    Measured 6 Months follow-up visit

Secondary Outcomes (3)

  • Parenting skills

    16 weeks and 6 months

  • Involvement in child mental health care

    16 weeks and 6 months

  • Parent/child interaction

    16 weeks and 6 months

Study Arms (2)

MFG therapy

EXPERIMENTAL

Participants will receive multi-family group therapy

Behavioral: MFG therapyBehavioral: Standard of Care

Standard of Care

ACTIVE COMPARATOR

Participants will receive standard care

Behavioral: Standard of Care

Interventions

MFG therapyBEHAVIORAL

MFG includes 16 weekly group therapy sessions for families with children who have ODD or CD. Sessions will include adult caregivers and all children over age 6. Each session will follow the same procedures, and will proceed through the following stages: creating social networks; information exchange; group discussions; individual family practice; and homework assignment.

Also known as: Multiple Family Group Project
MFG therapy
Standard of CareBEHAVIORAL

Participants assigned to standard care will receive treatment that is traditionally offered to outpatients. Participants in the MFG program will also receive standard care.

Also known as: Multiple Family Group Project, Standard care control
MFG therapyStandard of Care

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Youth participants are between the ages of 7 and 11
  • Adult caregivers are available to participate in the research and intervention activities
  • Both youth and adult caregiver are English- or Spanish-speaking
  • Youth meets criteria for a primary diagnosis of oppositional defiant disorder or conduct disorder, as measured by the Disruptive Behavior Disorder Rating Scale (DBD)

You may not qualify if:

  • Youth has significant cognitive impairment that might interfere with understanding of program content or informed consent process
  • Youth or adult has emergency psychiatric needs that require services beyond those provided within an outpatient setting (e.g., hospitalization or specialized placement outside the home)
  • Youth who are wards of the state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai's Child and Adolescent Outpatient Psychiatry Clinic

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Oppositional Defiant DisorderConduct Disorder

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Mary M. McKay, PhD

    Icahn School of Medicine at Mount Sinai, Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2006

First Posted

November 29, 2006

Study Start

October 1, 2006

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations

US(1)