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Clinical Trials/NCT00404911
NCT00404911
Completed
Not Applicable

Family Groups to Reduce Youth Behavioral Difficulties

Icahn School of Medicine at Mount Sinai1 site in 1 country416 target enrollmentOctober 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oppositional Defiant Disorder
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
416
Locations
1
Primary Endpoint
Youth externalizing behaviors and functioning
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2006
End Date
January 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Youth externalizing behaviors and functioning

Time Frame: Measured 6 Months follow-up visit

Secondary Outcomes

  • 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 Sites (1)

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