Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth

NCT ID: NCT00404911

Last Updated: 2013-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 416 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2013-01-31

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.

Conditions

Oppositional Defiant Disorder; Conduct Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MFG therapy

Participants will receive multi-family group therapy

Group Type: EXPERIMENTAL

MFG therapy

Intervention Type: BEHAVIORAL

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.

Standard of Care

Intervention Type: BEHAVIORAL

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

Standard of Care

Participants will receive standard care

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Multiple Family Group Project; Multiple Family Group Project; Standard care control

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

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary M. McKay, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai, Department of Psychiatry

Locations

Mount Sinai's Child and Adolescent Outpatient Psychiatry Clinic

New York, New York, United States

Countries

United States

Other Identifiers

R01MH072649

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR CT-C

Identifier Type: -

Identifier Source: secondary_id

GCO 04-0063

Identifier Type: -

Identifier Source: org_study_id