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Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth
This study is currently recruiting participants.
Study NCT00404911   Information provided by National Institute of Mental Health (NIMH)
First Received: November 28, 2006   Last Updated: April 10, 2009   History of Changes

November 28, 2006
April 10, 2009
October 2006
October 2011   (final data collection date for primary outcome measure)
Youth externalizing behaviors and functioning [ Time Frame: Measured at Weeks 8 and 16 of treatment and Months 6 and 18 follow-ups ] [ Designated as safety issue: No ]
Youth externalizing behaviors and functioning (measured at Weeks 8 and 16 and at follow-ups at Months 6 and 18)
Complete list of historical versions of study NCT00404911 on ClinicalTrials.gov Archive Site
  • Parenting skills [ Time Frame: Measured at Month 23 ] [ Designated as safety issue: No ]
  • Family functioning [ Time Frame: Measured at Month 23 ] [ Designated as safety issue: No ]
  • Involvement in child mental health care [ Time Frame: Measured at Month 23 ] [ Designated as safety issue: No ]
  • Service delivery process within family support [ Time Frame: Measured at Month 23 ] [ Designated as safety issue: No ]
  • Parent/child interaction [ Time Frame: Measured at Weeks 8 and 16 of treatment and Months 6 and 18 follow-ups ] [ Designated as safety issue: No ]
  • Parenting skills
  • Family Functioning
  • Involvement in child mental health care
  • Service delivery process within family support
  • Parent/child interaction (all measured at Weeks 8 and 16 and at follow-ups at Months 6 and 18)
 
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.

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.

 
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Oppositional Defiant Disorder and Conduct Disorder
  • Behavioral: Multiple family group (MFG) therapy
  • Behavioral: Standard care control
  • Experimental: Participants will receive multi-family group therapy
  • Active Comparator: Participants will receive standard care
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
372
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
7 Years and older
Yes
Contact: Lydia Franco, LMSW 212-659-8729 lydia.franco@mountsinai.org
Contact: Kara M. Dean-Assael, MSW 212-659-8729 mariakara@gmail.com
United States
 
NCT00404911
Mary M. McKay, PhD, Mt. Sinai School of Medicine- Department of Psychiatry
R01 MH072649, DSIR CT-C
National Institute of Mental Health (NIMH)
 
Principal Investigator: Mary M. McKay, PhD Mount Sinai School of Medicine, Department of Psychiatry
National Institute of Mental Health (NIMH)
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP