Randomized Trial of the Positive Action Program in Hawaii Schools

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of the Positive Action program on reducing negative behaviors, increasing positive behaviors and improving academic achievement of elementary school students.

Clinical Trial Description

This project will: 1) evaluate the efficacy of a comprehensive, multi-grade, multi-year program, the Positive Action program (PA) designed to reduce student problem behaviors (including drug use and violence), disciplinary referrals and suspensions, and academic underachievement; 2) evaluate the effects of the program on the presumed/theoretical mediator variables; and 3) assess which of these changes in mediator variables actually mediate the effects of the program on behavior and school performance. The Hawaiian school district has agreed to implement a randomized trial of the PA program. We randomly assigned schools to PA or control conditions from strata matched on multiple indicators of risk. PA schools will receive the full PA program for four years (the 2002-03 through 2005-06 school years). This includes all materials for all students (at all grades), families, teachers, and principal, plus community kits; training for teachers and other interested staff; and continuous technical support and monitoring by a PA staff person. Data on behavior and academic achievement will be obtained from school archival records for all students for all years and, where appropriate for several years prior to the study. Students in grades 1 and 3 in the 2001-02 school year and their parents and teachers will also be followed through the project with surveys every year. The subject population will contain equal portions of males and females, and proportionate numbers of the major ethnic groups on Oahu (Hawaiian or part-Hawaiian, white, Asian, Other). Analyses will test for program effects on all hypothesized mediating variables and outcomes, and the hypothesized mediational pathways. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00328445
Study type	Interventional
Source	National Institute on Drug Abuse (NIDA)
Contact
Status	Completed
Phase	N/A
Start date	April 2001
Completion date	June 2006

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.