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| Tracking Information | |||||
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| First Received Date ICMJE | June 18, 2003 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | June 1994 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00062959 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Preventing Problem Behavior Among Middle School Students | ||||
| Official Title ICMJE | Preventing Problem Behaviors Among Middle School Students | ||||
| Brief Summary | Problem behaviors such as drug use, violence, and school misconduct increase during adolescence. This study evaluated a program designed to prevent problem behaviors in middle school students; the program includes classroom instruction for students and home instruction for parents. |
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| Detailed Description | The prevalence of problem behaviors, such as school misconduct, underachievement, and dropout; tobacco, alcohol, and other drug use; and violence and delinquency, increases dramatically during adolescence. These behaviors place youths at an increased risk for school failure, involvement in the criminal justice system, and chronic substance abuse. The purpose of this study was to test the efficacy of a comprehensive program of interventions, called Going Places, that includes participatory classroom curriculum, parent education, and enhanced school environment. The primary goal of these components was to help students learn social competence skills that will help them make positive decisions in their lives. The classroom curriculum component was integrated into the participating schools' regular Language Arts curriculum in grades 6 through 8. The curriculum provided instruction in and opportunities to practice interpersonal communication, self-management, problem solving, and conflict management. Brief videotapes with student actors served as trigger films to stimulate student interest, provide models, and motivate prosocial behavior. Parents in the participating schools received instruction via videotape and print materials and participated in student homework exercises. The emphasis was on encouraging parents to remain involved, adopt creative monitoring practices, and foster adolescent autonomy by establishing rules and conditions leading incrementally to greater independence. Students in the seven Charles County, Maryland, middle schools were randomized either to the Going Places intervention group or to the usual education control group. The intervention was sequentially structured, with curricula implemented in each grade of middle school. Questionnaires were administered to all middle school students at the beginning of the 6th grade (before the intervention) to establish baseline levels of substance use, school misconduct, parent and peer influences, and school climate. Students completed surveys in the spring of grades 6, 7, and 8. A final follow-up survey was completed in the fall of ninth grade. The surveys assessed standard measures of tobacco, alcohol, and illicit drug use, school misconduct, and participation in school activities. The surveys also included items related to psychosocial, parental, and school factors. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Going Places: School program to prevent problem behavior | ||||
| 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 | 2768 | ||||
| Completion Date | June 2000 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria
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| Gender | Both | ||||
| Ages | 10 Years to 12 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00062959 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | N01HD33207, Z01 HD 02110-07-PR, NO1-HD-3-3207, NICHD-400 | ||||
| Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||
| Verification Date | May 2003 | ||||
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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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