Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth

Mount Sinai Health System

Status: Completed

Conditions: Oppositional Defiant Disorder; Conduct Disorder

Treatments: Behavioral: MFG therapy; Behavioral: Standard of Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00404911

GCO 04-0063

DSIR CT-C

R01MH072649 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 416 patients

Sex: All

Ages: 7+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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416 participants in 2 patient groups

MFG therapy

Experimental group

Description:

Participants will receive multi-family group therapy

Treatment:

Behavioral: Standard of Care

Behavioral: MFG therapy

Standard of Care

Active Comparator group

Description:

Participants will receive standard care

Treatment:

Behavioral: Standard of Care