CharacterNCT00328445
Randomized Trial of the Positive Action Program in Hawaii Schools
A study testing Positive Action in people with Character and Violence, run by National Institute on Drug Abuse (NIDA) at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Character, Violence, Substance Use
- What is being tested?
- Positive Action
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2001to Jun 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Public elementary schools K-5 or K-6
- All students in the study cohorts
Who cannot join
- Schools performing in top 50%
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Illinois at Chicago
Chicago, Illinois, 60607
Oregon State University
Corvallis, Oregon, 97331
Positive Action, Inc.
Twin Falls, Idaho, 83301
About this study
Official title: 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.
Read the 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.
- Conditions
- Character, Violence, Substance Use, Pro-social Behavior, Academic Achievement
- Being tested
- Positive Action
- Keywords
- Curriculum, Classroom management, School-wide climate, Parent involvement
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive ActionBehavioural
See publications
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Business as usual |
| Treatment | Experimental | Positive Action Receives: Behavioral: Positive Action |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported attitudes and behaviors
Measured: 2001-2006
Teacher reports of behaviors
Measured: 2001-2006
Parent reports of student behaviors
Measured: 2001-2006
Secondary outcomes (3)
School-level academic achievement test scores
Measured: 2000-2007
School-level reports of disciplinary referrals
Measured: 2000-2007
School-level reports of school quality
Measured: 2000-2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2006 (estimated)
- Study startApr 2001
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CharacterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, National Institute on Drug Abuse (NIDA)
- Investigators
- Brian R Flay, D.Phil., Principal investigator, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328445
- Sponsor's protocol ID
- R01DA013474
- Status last verified
- Sep 2014
- First submitted
- 19 May 2006
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 18780182Beets 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.
PubMed 19542037Snyder 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.
PubMed 20414477Snyder 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.
PubMed 22142170
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Positive Action Program: Outcomes and Mediators
- ClinicalTrials.gov ID
- NCT00328445
- Acronym / sponsor ID
- R01DA013474
- Conditions
- Character, Violence, Substance Use, Pro-social Behavior, Academic Achievement
- Keywords
- Curriculum, Classroom management, School-wide climate, Parent involvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Apr 2001
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 22 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Business as usual |
| Treatment | Experimental | Behavioral: Positive ActionPositive Action |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Public elementary schools K-5 or K-6
- All students in the study cohorts
Key exclusion criteria (1 listed)
- Schools performing in top 50%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive ActionSee publications | Behavioural | Treatment |
Primary outcome
Self-reported attitudes and behaviors
Time frame: 2001-2006
Teacher reports of behaviors
Time frame: 2001-2006
Parent reports of student behaviors
Time frame: 2001-2006
3 secondary outcomes
School-level academic achievement test scores
Time frame: 2000-2007
School-level reports of disciplinary referrals
Time frame: 2000-2007
School-level reports of school quality
Time frame: 2000-2007
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Background: PubMed 18780182Beets 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.
- Results publication: PubMed 19542037Beets 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.
- Results publication: PubMed 20414477Snyder 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.
- Results publication: PubMed 22142170Snyder 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.
- Link to information about the Positive Action programLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian R Flay, D.Phil. principal investigator
Oregon State University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Action in people with Character and Violence, run by National Institute on Drug Abuse (NIDA) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported attitudes and behaviors (time frame: 2001-2006). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00328445, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.