Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth

Family Groups to Reduce Youth Behavioral Difficulties

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.

Study Overview

• Status: Completed
• Conditions: Conduct Disorder; Oppositional Defiant Disorder
• Intervention / Treatment: Behavioral: MFG therapy; Behavioral: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Actual): 416
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai's Child and Adolescent Outpatient Psychiatry Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Youth externalizing behaviors and functioning	Measured at week 16 of treatment
Youth externalizing behaviors and functioning	Measured 6 Months follow-up visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting skills	change in parenting skills after intervention	16 weeks and 6 months
Involvement in child mental health care	comparison of involvement in child mental health care after intervention	16 weeks and 6 months
Parent/child interaction	change in parent and child interaction after intervention	16 weeks and 6 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Mary M. McKay, PhD, Icahn School of Medicine at Mount Sinai, Department of Psychiatry

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: November 28, 2006
• First Submitted That Met QC Criteria: November 28, 2006
• First Posted (Estimate): November 29, 2006

Study Record Updates

• Last Update Posted (Estimate): June 25, 2013
• Last Update Submitted That Met QC Criteria: June 21, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Oppositional Defiant Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurodevelopmental Disorders; Disease; Conduct Disorder; Attention Deficit and Disruptive Behavior Disorders
• Other Study ID Numbers: GCO 04-0063; DSIR CT-C; R01MH072649 (U.S. NIH Grant/Contract)