Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00404911

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 and Conduct Disorder	Behavioral: Multiple family group (MFG) therapy Behavioral: Standard care control

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Family Groups to Reduce Youth Behavioral Difficulties

Resource links provided by NLM:

MedlinePlus related topics: Child Mental Health Mental Health

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	372
Study Start Date:	October 2006
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive multi-family group therapy	Behavioral: Multiple family group (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. Behavioral: Standard care control Participants assigned to standard care will receive treatment that is traditionally offered to outpatients. Participants in the MFG program will also receive standard care.
2: Active Comparator Participants will receive standard care	Behavioral: Standard care control Participants assigned to standard care will receive treatment that is traditionally offered to outpatients. Participants in the MFG program will also receive standard care.

Arms

Assigned Interventions

1: Experimental

Participants will receive multi-family group therapy

Behavioral: Multiple family group (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.

Behavioral: Standard care control

Participants assigned to standard care will receive treatment that is traditionally offered to outpatients. Participants in the MFG program will also receive standard care.

2: Active Comparator

Participants will receive standard care

Behavioral: Standard care control

Participants assigned to standard care will receive treatment that is traditionally offered to outpatients. Participants in the MFG program will also receive standard 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.

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

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

Contacts

Contact: Lydia Franco, LMSW	212-659-8729	lydia.franco@mountsinai.org
Contact: Kara M. Dean-Assael, MSW	212-659-8729	mariakara@gmail.com

Locations

United States, New York
Mount Sinai's Child and Adolescent Outpatient Psychiatry Clinic	Recruiting
New York, New York, United States, 10029
Contact: Lydia Franco, LMSW 212-659-8729 lydia.franco@mountsinai.org
Contact: Kara M. Dean-Assael, MSW 212-659-8729 mariakara@gmail.com
Principal Investigator: Mary M. McKay, PhD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Mary M. McKay, PhD

Mount Sinai School of Medicine, Department of Psychiatry

More Information

No publications provided

Responsible Party:	Mt. Sinai School of Medicine- Department of Psychiatry ( Mary M. McKay, PhD )
Study ID Numbers:	R01 MH072649, DSIR CT-C
Study First Received:	November 28, 2006
Last Updated:	April 10, 2009
ClinicalTrials.gov Identifier:	NCT00404911 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Oppositional Defiant Disorder

Additional relevant MeSH terms:

Conduct Disorder
Pathologic Processes
Disease

Mental Disorders
Mental Disorders Diagnosed in Childhood
Attention Deficit and Disruptive Behavior Disorders

ClinicalTrials.gov processed this record on November 27, 2009