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Randomized Trial of the Positive Action Program in Chicago Schools and Extension to Grade 8

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01025674
First Posted: December 3, 2009
Last Update Posted: April 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Illinois at Chicago
Information provided by (Responsible Party):
Brian Flay, Oregon State University
  Purpose
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.

Condition Intervention
Character Violence Substance Use Pro-Social Behavior Academic Achievement Behavioral: Positive Action program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Positive Action for Social and Character Development

Further study details as provided by Brian Flay, Oregon State University:

Primary Outcome Measures:
  • Local Site Scales - Student self-reported behaviors. School and Classroom Climate: Improved relationships [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Current at time of asking, asked at beginning and end of grades 3 and 4, and end of grade 5 ]

Secondary Outcome Measures:
  • Student scores on attitudinal measures [ Time Frame: End of grades 3, 4, 5, 7 and 8 ]
  • Student scores on academic achievement tests [ Time Frame: End of grades 3, 4, 5, 7 and 8 ]
  • School-level reports of disciplinary referrals [ Time Frame: End of grades 3, 4, 5, 7 and 8 ]
  • School-level scores on standardized achievement tests [ Time Frame: End of grades 3, 4, 5, 7 and 8 ]
  • Fidelity/Implementation Measures for Treatment Schools: Teacher online reports of Positive Action (PA) classroom activities [ Time Frame: At end of each of 6 Positive Action (PA) teaching units ]
  • Fidelity/Implementation Measures for Treatment Schools: Teacher Unit reports [ Time Frame: Weekly ]
  • Student height and weight [ Time Frame: Beginning and end of Grade 7 and end of Grade 8 ]
  • Process evaluation data from students and teachers [ Time Frame: fall 2008, spring 2009 and 2010 ]

Enrollment: 4230
Study Start Date: September 2004
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 7 Treatment Schools
The Positive Action program was implemented over 6 years, starting with Grade 3, then continuing through Grade 8.
Behavioral: Positive Action program
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.
No Intervention: 7 Control Schools
Standard educational practice

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria: Reverse of inclusion criteria

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01025674


Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Oregon
Oregon State University
Corvallis, Oregon, United States, 97331
Sponsors and Collaborators
Oregon State University
University of Illinois at Chicago
Investigators
Principal Investigator: Brian R. Flay, D.Phil. Oregon State University
  More Information

Additional Information:
Publications:

Responsible Party: Brian Flay, Professor, Oregon State University
ClinicalTrials.gov Identifier: NCT01025674     History of Changes
Other Study ID Numbers: R305A080253
R305L030004 ( Other Grant/Funding Number: U.S. Dept. of Education )
R305A080253 ( Other Grant/Funding Number: U.S. Dept. of Education )
R305L030072 ( Other Grant/Funding Number: Institue of Education Sciences, US Department of Education )
First Submitted: December 1, 2009
First Posted: December 3, 2009
Last Update Posted: April 22, 2015
Last Verified: September 2014

Keywords provided by Brian Flay, Oregon State University:
School health program
Positive health behavior
School-wide climate
Mental health
Self-esteem
Social support
Exercise
Nutrition
Parent involvement
Community involvement