- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00328445
Randomized Trial of the Positive Action Program in Hawaii Schools
January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)
The Positive Action Program: Outcomes and Mediators
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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 Type
Interventional
Enrollment (Actual)
2500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Idaho
-
Twin Falls, Idaho, United States, 83301
- Positive Action, Inc.
-
-
Illinois
-
Chicago, Illinois, United States, 60607
- University of Illinois at Chicago
-
-
Oregon
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Corvallis, Oregon, United States, 97331
- Oregon State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Public elementary schools K-5 or K-6
- All students in the study cohorts
Exclusion Criteria:
- Schools performing in top 50%
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Business as usual
|
|
|
Experimental: Treatment
Positive Action
|
See publications
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Self-reported attitudes and behaviors
Time Frame: 2001-2006
|
2001-2006
|
|
Teacher reports of behaviors
Time Frame: 2001-2006
|
2001-2006
|
|
Parent reports of student behaviors
Time Frame: 2001-2006
|
2001-2006
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
School-level academic achievement test scores
Time Frame: 2000-2007
|
2000-2007
|
|
School-level reports of disciplinary referrals
Time Frame: 2000-2007
|
2000-2007
|
|
School-level reports of school quality
Time Frame: 2000-2007
|
2000-2007
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Brian R Flay, D.Phil., Oregon State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Beets MW, Flay BR, Vuchinich S, Acock AC, Li KK, Allred C. School climate and teachers' beliefs and attitudes associated with implementation of the positive action program: a diffusion of innovations model. Prev Sci. 2008 Dec;9(4):264-75. doi: 10.1007/s11121-008-0100-2. Epub 2008 Sep 9.
- Beets MW, Flay BR, Vuchinich S, Snyder FJ, Acock A, Li KK, Burns K, Washburn IJ, Durlak J. Use of a social and character development program to prevent substance use, violent behaviors, and sexual activity among elementary-school students in Hawaii. Am J Public Health. 2009 Aug;99(8):1438-45. doi: 10.2105/AJPH.2008.142919. Epub 2009 Jun 18.
- Snyder F, Flay B, Vuchinich S, Acock A, Washburn I, Beets M, Li KK. Impact of a social-emotional and character development program on school-level indicators of academic achievement, absenteeism, and disciplinary outcomes: A matched-pair, cluster randomized, controlled trial. J Res Educ Eff. 2010 Jan;3(1):26-55. doi: 10.1080/19345740903353436.
- Snyder FJ, Vuchinich S, Acock A, Washburn IJ, Flay BR. Improving elementary school quality through the use of a social-emotional and character development program: a matched-pair, cluster-randomized, controlled trial in Hawai'i. J Sch Health. 2012 Jan;82(1):11-20. doi: 10.1111/j.1746-1561.2011.00662.x.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2001
Primary Completion (Actual)
June 1, 2006
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
May 19, 2006
First Submitted That Met QC Criteria
May 19, 2006
First Posted (Estimate)
May 22, 2006
Study Record Updates
Last Update Posted (Estimate)
January 12, 2017
Last Update Submitted That Met QC Criteria
January 11, 2017
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DA013474 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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