Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth

Conduct Disorder Clinical Trial

Official title:

Family Groups to Reduce Youth Behavioral Difficulties

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404911
• Other study ID #: GCO 04-0063
• Secondary ID: R01MH072649DSIR
• Status: Completed
• Phase: N/A
• First received: November 28, 2006
• Last updated: June 21, 2013
• Start date: October 2006
• Est. completion date: January 2013

Study information

• Verified date: June 2013
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Conduct Disorder
• Disease
• Oppositional Defiant Disorder

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Mount Sinai's Child and Adolescent Outpatient Psychiatry Clinic	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Youth externalizing behaviors and functioning		Measured at week 16 of treatment	No
Primary	Youth externalizing behaviors and functioning		Measured 6 Months follow-up visit	No
Secondary	Parenting skills	change in parenting skills after intervention	16 weeks and 6 months	No
Secondary	Involvement in child mental health care	comparison of involvement in child mental health care after intervention	16 weeks and 6 months	No
Secondary	Parent/child interaction	change in parent and child interaction after intervention	16 weeks and 6 months	No