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Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth

Primary Purpose

Oppositional Defiant Disorder, Conduct Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MFG therapy
Standard of Care
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oppositional Defiant Disorder focused on measuring Oppositional Defiant Disorder

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Mount Sinai's Child and Adolescent Outpatient Psychiatry Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MFG therapy

Standard of Care

Arm Description

Participants will receive multi-family group therapy

Participants will receive standard care

Outcomes

Primary Outcome Measures

Youth externalizing behaviors and functioning
Youth externalizing behaviors and functioning

Secondary Outcome Measures

Parenting skills
change in parenting skills after intervention
Involvement in child mental health care
comparison of involvement in child mental health care after intervention
Parent/child interaction
change in parent and child interaction after intervention

Full Information

First Posted
November 28, 2006
Last Updated
June 21, 2013
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00404911
Brief Title
Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth
Official Title
Family Groups to Reduce Youth Behavioral Difficulties
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Oppositional defiant disorder (ODD) and conduct disorder (CD) are two common childhood psychiatric disorders. Children with ODD frequently have temper tantrums, argue excessively with adults, deliberately attempt to annoy or upset people, and blame others for their mistakes or behavior. Children with CD may exhibit aggression toward people and animals, destruction of property, deceitfulness, and rule breaking. The symptoms of these disorders can negatively affect children's social, family, and academic lives. Research has shown that early, comprehensive treatment leads to better treatment outcomes. Both disorders are commonly treated using parent training techniques. A multiple family group therapy setting may prove to be more engaging and beneficial than standard care for both parents and children. This study will examine the effectiveness of a multiple family group (MFG) mental health service delivery strategy in improving mental health service use and treatment outcome for urban, low income children of color with ODD or CD. Participants in this 18-month, open-label study will be randomly assigned to either receive standard of care or participate in an MFG in addition to receiving standard of care. Participants assigned to standard of care will receive treatment that is traditionally offered to outpatients. Participants in an MFG will meet in their groups once a week for 16 weeks. 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. Assessments of youth functioning will be held at Weeks 8 and 16 and Months 6 and 18 post-treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oppositional Defiant Disorder, Conduct Disorder
Keywords
Oppositional Defiant Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
416 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MFG therapy
Arm Type
Experimental
Arm Description
Participants will receive multi-family group therapy
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Participants will receive standard care
Intervention Type
Behavioral
Intervention Name(s)
MFG therapy
Other Intervention Name(s)
Multiple Family Group Project
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
Multiple Family Group Project, Standard care control
Intervention Description
Participants assigned to standard care will receive treatment that is traditionally offered to outpatients. Participants in the MFG program will also receive standard care.
Primary Outcome Measure Information:
Title
Youth externalizing behaviors and functioning
Time Frame
Measured at week 16 of treatment
Title
Youth externalizing behaviors and functioning
Time Frame
Measured 6 Months follow-up visit
Secondary Outcome Measure Information:
Title
Parenting skills
Description
change in parenting skills after intervention
Time Frame
16 weeks and 6 months
Title
Involvement in child mental health care
Description
comparison of involvement in child mental health care after intervention
Time Frame
16 weeks and 6 months
Title
Parent/child interaction
Description
change in parent and child interaction after intervention
Time Frame
16 weeks and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary M. McKay, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai, Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai's Child and Adolescent Outpatient Psychiatry Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

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Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth

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