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Examining Variation in the Impact of School-Wide Positive Behavioral Interventions and Supports (PBIS)

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ClinicalTrials.gov Identifier: NCT01583127
Recruitment Status : Completed
First Posted : April 23, 2012
Last Update Posted : February 24, 2016
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Centers for Disease Control and Prevention
U.S. Department of Education
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Tracking Information
First Submitted Date  ICMJE April 20, 2012
First Posted Date  ICMJE April 23, 2012
Last Update Posted Date February 24, 2016
Study Start Date  ICMJE September 2002
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2012)
Teacher ratings [ Time Frame: 5 time points over 4 years ]
teacher ratings of students prosocial behavior, emotion regulation, conduct problems, and aggressive behavior
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01583127 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2016)
  • student discipline data [ Time Frame: 5 time points over 5 years ]
    suspensions, office discipline referrals
  • school climate [ Time Frame: 5 time points over 5 years ]
    teacher and student reports of school climate
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2012)
  • student discipline data [ Time Frame: 5 timpoints over 5 years ]
    suspensions, office discipline referrals
  • school climate [ Time Frame: 5 time points over 5 years ]
    teacher and student reports of school climate
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Examining Variation in the Impact of School-Wide Positive Behavioral Interventions and Supports (PBIS)
Official Title  ICMJE Examining Variation in the Impact of School-Wide Positive Behavioral Interventions and Supports (PBIS)
Brief Summary To conduct a randomized controlled trial of School-Wide Positive Behavioral Interventions and Supports, which is a school-based prevention program aimed at reducing behavior problems in children.
Detailed Description To conduct a group randomized controlled trial of School-Wide Positive Behavioral Interventions and Supports. PBIS is a popular school-based prevention program aimed at reducing behavior problems in children. Staff are trained to implement behavioral focused prevention programs to address issues related to student conduct and discipline problems.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Problem Behavior
Intervention  ICMJE Behavioral: Positive Behavioral Interventions & Supports
Implementation of the School-Wide Positive Behavioral Interventions and Supports model across 4 school years.
Other Name: Positive Behavior Supports
Study Arms  ICMJE
  • Experimental: School-Wide (SW)-PBIS intervention
    SW-PBIS intervention
    Intervention: Behavioral: Positive Behavioral Interventions & Supports
  • No Intervention: Control
    Practice as usual
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2012)
32986
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Public Elementary Schools
  • All children attending the schools and staff employed were eligible for inclusion

Exclusion Criteria:

• None

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01583127
Other Study ID Numbers  ICMJE H.33.02.03.07.A
R01MH067948 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins Bloomberg School of Public Health
Study Sponsor  ICMJE Johns Hopkins Bloomberg School of Public Health
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • Centers for Disease Control and Prevention
  • U.S. Department of Education
Investigators  ICMJE
Principal Investigator: Catherine P Bradshaw, PhD Johns Hopkins Bloomberg School of Public Health
PRS Account Johns Hopkins Bloomberg School of Public Health
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP