Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00404911
First received: November 28, 2006
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Oppositional Defiant Disorder
Conduct Disorder
Behavioral: MFG therapy
Behavioral: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Family Groups to Reduce Youth Behavioral Difficulties

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Youth externalizing behaviors and functioning [ Time Frame: Measured at week 16 of treatment ] [ Designated as safety issue: No ]
  • Youth externalizing behaviors and functioning [ Time Frame: Measured 6 Months follow-up visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parenting skills [ Time Frame: 16 weeks and 6 months ] [ Designated as safety issue: No ]
    change in parenting skills after intervention

  • Involvement in child mental health care [ Time Frame: 16 weeks and 6 months ] [ Designated as safety issue: No ]
    comparison of involvement in child mental health care after intervention

  • Parent/child interaction [ Time Frame: 16 weeks and 6 months ] [ Designated as safety issue: No ]
    change in parent and child interaction after intervention


Enrollment: 416
Study Start Date: October 2006
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MFG therapy
Participants will receive multi-family group therapy
Behavioral: MFG therapy
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.
Other Name: Multiple Family Group Project
Behavioral: Standard of Care
Participants assigned to standard care will receive treatment that is traditionally offered to outpatients. Participants in the MFG program will also receive standard care.
Other Names:
  • Multiple Family Group Project
  • Standard care control
Active Comparator: Standard of Care
Participants will receive standard care
Behavioral: Standard of Care
Participants assigned to standard care will receive treatment that is traditionally offered to outpatients. Participants in the MFG program will also receive standard care.
Other Names:
  • Multiple Family Group Project
  • Standard care control

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.

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404911

Locations
United States, New York
Mount Sinai's Child and Adolescent Outpatient Psychiatry Clinic
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Mary M. McKay, PhD Icahn School of Medicine at Mount Sinai, Department of Psychiatry
  More Information

No publications provided

Responsible Party: Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00404911     History of Changes
Other Study ID Numbers: GCO 04-0063, R01MH072649, DSIR CT-C
Study First Received: November 28, 2006
Last Updated: June 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Oppositional Defiant Disorder

Additional relevant MeSH terms:
Conduct Disorder
Disease
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014