NCT01025674

Brief Summary

This project focuses on social and character development of elementary and middle school-aged children and responds to an urgent national need that schools improve their capacity to address a range of student outcomes, including social skills, character, behavior, academic achievement and health outcomes. This study is a school-based randomized trial to evaluate the Positive Action program. The Positive Action program was designed to promote social and character development and improve behavior and school performance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

April 22, 2015

Status Verified

September 1, 2014

Enrollment Period

5.8 years

First QC Date

December 1, 2009

Last Update Submit

April 20, 2015

Conditions

CharacterViolenceSubstance UsePro-Social BehaviorAcademic Achievement

Keywords

School health programPositive health behaviorSchool-wide climateMental healthSelf-esteemSocial supportExerciseNutritionParent involvementCommunity involvement

Outcome Measures

Primary Outcomes (11)

  • Local Site Scales - Student self-reported behaviors. School and Classroom Climate: Improved relationships

    Current at time of asking, asked at beginning and end of grades 3 and 4, and end of grade 5, beginning and end of grade 7 and end of grade 8

  • Local Site Scales - Student self-reported behaviors. Expected Student Effects: Improvement in each: Attachment/Normative Beliefs; Attitudes Towards Behaviors; Self-Efficacy/Self-Esteem; Academic/Social Skills; Character and Social Development

    Current at time of asking, asked at beginning and end of grades 3 and 4, and end of grade 5, beginning and end of grade 7 and end of grade 8

  • Local Site Scales - Student self-reported behaviors. Expected Impacts: Reduced Emotional Problems; Improved Health Behavior; Reduced Substance Use; Less Violence; Improved Grades and Test Scores

    Current at time of asking, asked at beginning and end of grades 3 and 4, and end of grade 5, beginning and end of grade 7 and end of grade 8

  • Multi-site Scales - Student self-reported behaviors. School and Classroom Climate: Improved Relationships

    Current at time of asking, asked at beginning and end of grades 3 and 4, and end of grade 5

  • Multi-site Scales - Student self-reported behaviors. Expected Student Effects: Improved Attitudes Towards Behaviors; Improved Self-Efficacy/Self-Esteem; Improved Character and Social Development

    Current at time of asking, asked at beginning and end of grades 3 and 4, and end of grade 5

  • Multi-site Scales - Student self-reported behaviors. Expected Impacts: Reduced Emotional Problems; Fewer Behavioral/Disciplinary Problems

    Current at time of asking, asked at beginning and end of grades 3 and 4, and end of grade 5

  • Multi-site Scales - Parent Reports of student behaviors. School and Classroom Climate: Improved Relationships; Increased Involvement of School with Parents and Community

    Current at time of asking, asked at beginning and end of grades 3 and 4, and end of grade 5

  • Multi-site Scales - Parent Reports of student behaviors. Expected Student Effects: Improved Academic/Social Skills; Improved Character and Social Development; Fewer Behavioral/Disciplinary Problems

    Current at time of asking, asked at beginning and end of grades 3 and 4, and end of grade 5

  • Multi-site Scales - Teacher Reports of student behaviors. School and Classroom Climate: Improved Relationships; Increased Amount/Quality Social/Character Development Activities used by School; Increased Involvement of School with Parents/Community

    Current at time of asking, asked at beginning and end of grades 3 and 4, and end of grade 5

  • Multi-site Scales - Teacher Reports of student behaviors. Expected Student Effects: Improved Academic/Social Skills; Improved Character and Social Development

    Current at time of asking, asked at beginning and end of grades 3 and 4, and end of grade 5

  • Multi-site Scales - Teacher Reports of student behaviors. Expected Impacts: Fewer Behavioral/Disciplinary Problems

    Current at time of asking, asked at beginning and end of grades 3 and 4, and end of grade 5

Secondary Outcomes (8)

  • Student scores on attitudinal measures

    End of grades 3, 4, 5, 7 and 8

  • Student scores on academic achievement tests

    End of grades 3, 4, 5, 7 and 8

  • School-level reports of disciplinary referrals

    End of grades 3, 4, 5, 7 and 8

  • School-level scores on standardized achievement tests

    End of grades 3, 4, 5, 7 and 8

  • Fidelity/Implementation Measures for Treatment Schools: Teacher online reports of Positive Action (PA) classroom activities

    At end of each of 6 Positive Action (PA) teaching units

  • +3 more secondary outcomes

Study Arms (2)

7 Treatment Schools

EXPERIMENTAL

The Positive Action program was implemented over 6 years, starting with Grade 3, then continuing through Grade 8.

Behavioral: Positive Action program

7 Control Schools

NO INTERVENTION

Standard educational practice

Interventions

Positive Action programBEHAVIORAL

Components of the Positive Action program (6 units) use research-supported educational strategies/methods that include active learning, positive classroom management, teacher training, detailed curriculum with almost daily lessons, school-wide climate-change program, and family program of parent support/involvement.

7 Treatment Schools

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Public elementary schools Pre-K or K through grade 5 or 6; Schools were included in the study if they:
  • Are community-based (that is, not magnet, academy, special ed., etc.),
  • Have at least 60 students and two classrooms of grades 2, 3, 4, and 5,
  • Have no more than 100 students or 3 classrooms per grade level,
  • Have annual mobility rates no greater than 30% (meaning that approximately 15% move out of the school and 15% more into the school each year),
  • Have at least 50% of students eligible for free or reduced price lunch,
  • Are relatively low performing on standardized tests,
  • Have not used Positive Action program in the last decade,
  • Are not doing another social/character program.
  • All students in the study cohorts - those in grade 3 in 2004-05

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Oregon State University

Corvallis, Oregon, 97331, United States

Location

Related Publications (10)

  • Ji P, Flay BR, Dubois DL, Brechling V, Day J, Cantillon D. Consent form return rates for third-grade urban elementary students. Am J Health Behav. 2006 Sep-Oct;30(5):467-74. doi: 10.5555/ajhb.2006.30.5.467.

    PMID: 16893309BACKGROUND

  • Ji P, DuBois DL, Flay BR, Brechling V. "Congratulations, you have been randomized into the control group!(?)": issues to consider when recruiting schools for matched-pair randomized control trials of prevention programs. J Sch Health. 2008 Mar;78(3):131-9. doi: 10.1111/j.1746-1561.2007.00275.x.

    PMID: 18307608BACKGROUND

  • Jarpe-Ratner E, Fagen M, Day J, Gilmet K, Prudowsky J, Neiger BL, DuBois DL, Flay BR. Using the community readiness model as an approach to formative evaluation. Health Promot Pract. 2013 Sep;14(5):649-55. doi: 10.1177/1524839913487538. Epub 2013 May 23.

    PMID: 23703848BACKGROUND

  • Li KK, Washburn I, DuBois DL, Vuchinich S, Ji P, Brechling V, Day J, Beets MW, Acock AC, Berbaum M, Snyder F, Flay BR. Effects of the Positive Action programme on problem behaviours in elementary school students: a matched-pair randomised control trial in Chicago. Psychol Health. 2011 Feb;26(2):187-204. doi: 10.1080/08870446.2011.531574.

    PMID: 21318929RESULT

  • Washburn IJ, Acock A, Vuchinich S, Snyder F, Li KK, Ji P, Day J, DuBois D, Flay BR. Effects of a social-emotional and character development program on the trajectory of behaviors associated with social-emotional and character development: findings from three randomized trials. Prev Sci. 2011 Sep;12(3):314-23. doi: 10.1007/s11121-011-0230-9.

    PMID: 21720782RESULT

  • Lewis KM, Bavarian N, Snyder FJ, Acock A, Day J, Dubois DL, Ji P, Schure MB, Silverthorn N, Vuchinich S, Flay BR. Direct and Mediated Effects of a Social-Emotional and Character Development Program on Adolescent Substance Use. Int J Emot Educ. 2012 Apr;4(1):56-78.

    PMID: 24308013RESULT

  • Lewis KM, Schure MB, Bavarian N, DuBois DL, Day J, Ji P, Silverthorn N, Acock A, Vuchinich S, Flay BR. Problem behavior and urban, low-income youth: a randomized controlled trial of positive action in Chicago. Am J Prev Med. 2013 Jun;44(6):622-30. doi: 10.1016/j.amepre.2013.01.030.

    PMID: 23683980RESULT

  • Bavarian N, Lewis KM, Dubois DL, Acock A, Vuchinich S, Silverthorn N, Snyder FJ, Day J, Ji P, Flay BR. Using social-emotional and character development to improve academic outcomes: a matched-pair, cluster-randomized controlled trial in low-income, urban schools. J Sch Health. 2013 Nov;83(11):771-9. doi: 10.1111/josh.12093.

    PMID: 24138347RESULT

  • Lewis KM, DuBois DL, Bavarian N, Acock A, Silverthorn N, Day J, Ji P, Vuchinich S, Flay BR. Effects of Positive Action on the emotional health of urban youth: a cluster-randomized trial. J Adolesc Health. 2013 Dec;53(6):706-11. doi: 10.1016/j.jadohealth.2013.06.012. Epub 2013 Jul 26.

    PMID: 23890774RESULT

  • Bavarian N, Lewis KM, Holloway S, Wong L, Silverthorn N, DuBois DL, Flay BR, Siebert C. Mechanisms of Influence on Youth Substance Use for a Social-Emotional and Character Development Program: A Theory-Based Approach. Subst Use Misuse. 2022;57(12):1854-1863. doi: 10.1080/10826084.2022.2120359. Epub 2022 Sep 11.

    PMID: 36093809DERIVED

Related Links

MeSH Terms

Conditions

Substance-Related DisordersPsychological Well-BeingMotor Activity

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersPersonal SatisfactionBehavior

Study Officials

  • Brian R. Flay, D.Phil.

    Oregon State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 1, 2009

First Posted

December 3, 2009

Study Start

September 1, 2004

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

April 22, 2015

Record last verified: 2014-09

Locations

US(2)