A Family Intervention for Adolescent Problem Behavior (AKA Project Alliance 2) (PAL-2)
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| First Received Date ICMJE | August 16, 2011 | ||||||||||||||||
| Last Updated Date | December 8, 2011 | ||||||||||||||||
| Start Date ICMJE | February 2006 | ||||||||||||||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT01490307 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | A Family Intervention for Adolescent Problem Behavior (AKA Project Alliance 2) | ||||||||||||||||
| Official Title ICMJE | A Family Intervention for Adolescent Problem Behavior | ||||||||||||||||
| Brief Summary | The goal of this project is to empirically refine and improve a comprehensive family-centered prevention strategy for reducing and preventing adolescent substance use and other problem behaviors. This project builds on 15 years of programmatic research underlying the development of the Family Check-up model (FCU), originally referred to as the Adolescent Transitions Program (ATP; Dishion & Kavanagh, 2003), but later expanded as a general approach to mental health treatment for children from ages 2 through 17 (Dishion & Stormshak, 2007). The FCU model is a multilevel, family-centered strategy delivered within the context of a public school setting that comprehensively links universal, selected, and indicated family interventions. Previous research and the investigators' practical experience working in school settings indicate that the intervention strategy needs improvement in 3 critical areas to build on previous significant effects and to enhance the potential for future dissemination and large-scale implementation:(a) improve the feasibility of both the universal level and the indicated level of the intervention by broadening the intervention components and systematically embedding these components into the current behavioral support systems in the schools; (b) address the transition from middle school to high school, with special attention to academic engagement and reduction of deviant peer clustering; and (c) explicitly incorporate principals of successful interventions with families and young adolescents of diverse ethnic groups into both the universal and indicated models. An additional general goal of this study is to develop, test, and refine a set of research-based instruments that facilitate evaluation, training, implementation, and monitoring of intervention fidelity to maximize the potential success of implementation and large-scale dissemination. Participants include 593 youth and their families recruited from the 6th grade in three public middle schools in Portland, OR. Families were randomly assigned to receive either the FCU intervention model or treatment as usual. Assessments were collected for 5 years through the 10th grade. High school transition planning and intensive intervention efforts occurred in Grades 7-9. The investigators tested the hypothesis that the FCU intervention will reduce the growth of problem behavior and substance use through the enhancement of family management and parent involvement in school. |
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| Detailed Description | Specific aims of the current project are to:
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| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Family Check-Up
The Family Check-Up starts with a rapport-building session that allows therapists to gauge parents' concerns and motivation for change. This is followed by a thorough assessment of individual family strengths and weaknesses, utilizing parent and child questionnaires and family video observations. Parents then receive feedback on the results of the assessment using motivational interviewing techniques. Attention is focused on parents' and children's readiness to change, as well as the delineation of specific change options. Families may continued to receive tailored intervention services using the Everyday Parenting Curriculum.
Other Names:
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||
| Enrollment ICMJE | 593 | ||||||||||||||||
| Completion Date | March 2011 | ||||||||||||||||
| Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Parents of all sixth grade students across 2 cohorts at 3 public middle schools were invited to participate in this study. |
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| Gender | Both | ||||||||||||||||
| Ages | Not Provided | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | United States | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT01490307 | ||||||||||||||||
| Other Study ID Numbers ICMJE | R01DA018374, R01DA018374 | ||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||
| Responsible Party | University of Oregon | ||||||||||||||||
| Study Sponsor ICMJE | University of Oregon | ||||||||||||||||
| Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | ||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of Oregon | ||||||||||||||||
| Verification Date | December 2011 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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