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| Tracking Information | |||||
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| First Received Date ICMJE | January 15, 2003 | ||||
| Last Updated Date | November 17, 2005 | ||||
| Start Date ICMJE | October 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00051727 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prevention of School Dropout for Mexican American Adolescents | ||||
| Official Title ICMJE | Preventive Intervention for Mexican American Adolescents | ||||
| Brief Summary | The purpose of this study is to test the efficacy of a family-based psychosocial intervention to prevent school disengagement and reduce the incidence of depression, conduct disorders, and school dropout for Mexican American adolescents. |
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| Detailed Description | Mexican American adolescents are at an increased risk for interrelated problems of poor mental health and school dropout. Unfortunately, there is a lack of interventions specifically designed to address this risk. This study will evaluate a preventive intervention for low-income Mexican American adolescents. Participants are randomly assigned to either a multi-component intervention called the Bridges to High School Program or a Low Dose Workshop. The 11-week multi-component intervention takes place during the fall semester of seventh grade and consists of an adolescent group, a parenting group, a combined (parent-adolescent) family group, and a school liaison. This intervention focuses on adolescent coping skills, parenting practices, family cohesion, and parental support for education. The Low-Dose Workshop consists of a 3-hour workshop in which adolescents and parents are given information and resources to facilitate school engagement. Participants are assessed prior to and immediately following the intervention and again in eighth and ninth grade. Academic and mental health outcomes are measured with questionnaire-based interviews given to caregivers and adolescents. Teachers are asked to complete questionnaires; archival school data are also collected. Diagnostic interviews are conducted at the ninth grade assessment. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Bridges to High School Project | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 480 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 10 Years to 15 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00051727 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R01 MH64707, DSIR 84-CTP | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | November 2005 | ||||
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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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