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| Brief Title † | Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth | ||||||||
| Official Title † | Family Groups to Reduce Youth Behavioral Difficulties | ||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | 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 Measure † | 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 ] |
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| Condition † | Oppositional Defiant Disorder and Conduct Disorder | ||||||||
| Intervention † | Behavioral: Multiple family group (MFG) therapy Behavioral: Standard care control |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 372 | ||||||||
| Start Date † | October 2006 | ||||||||
| Completion Date | October 2011 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 7 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00404911 | ||||||||
| Organization ID | R01 MH72649 | ||||||||
| Secondary IDs †† | DSIR CT-C | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | September 2008 | ||||||||
| First Received Date † | November 28, 2006 | ||||||||
| Last Updated Date | September 19, 2008 | ||||||||
