Clinical trial NCT00404911: Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth
Official title: Family Groups to Reduce Youth Behavioral Difficulties
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oppositional Defiant Disorder
Conduct Disorder
Keywords: Oppositional Defiant Disorder
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-11-29
Enrollment: 416
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Youth externalizing behaviors and functioning
timeFrame: Measured at week 16 of treatment
measure: Youth externalizing behaviors and functioning
timeFrame: Measured 6 Months follow-up visit
Secondary outcomes:
measure: Parenting skills
timeFrame: 16 weeks and 6 months
measure: Involvement in child mental health care
timeFrame: 16 weeks and 6 months
measure: Parent/child interaction
timeFrame: 16 weeks and 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai's Child and Adolescent Outpatient Psychiatry Clinic
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai, Department of Psychiatry
name: Mary M. McKay, PhD
role: PRINCIPAL_INVESTIGATOR
References: