Problem BehaviorNCT01583127
Examining Variation in the Impact of School-Wide Positive Behavioral Interventions and Supports (PBIS)
A study testing Positive Behavioral Interventions & Supports in people with Problem Behavior, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Problem Behavior
- What is being tested?
- Positive Behavioral Interventions & Supports
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32,986 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Jun 2007
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Public Elementary Schools
- All children attending the schools and staff employed were eligible for inclusion
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Public Health
Baltimore, Maryland, 21205
About this study
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.
Read the 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.
- Conditions
- Problem Behavior
- Being tested
- Positive Behavioral Interventions & Supports
- Keywords
- Problem Behavior
- Medical subject headings
- Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Behavioral Interventions & SupportsBehavioural
Also called Positive Behavior Supports
Implementation of the School-Wide Positive Behavioral Interventions and Supports model across 4 school years.
| Study group | Role | What they receive |
|---|---|---|
| School-Wide (SW)-PBIS intervention | Experimental | SW-PBIS intervention Receives: Behavioral: Positive Behavioral Interventions & Supports |
| Control | No intervention | Practice as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Teacher ratings
teacher ratings of students prosocial behavior, emotion regulation, conduct problems, and aggressive behavior
Measured: 5 time points over 4 years
Secondary outcomes (2)
student discipline data
suspensions, office discipline referrals
Measured: 5 time points over 5 years
school climate
teacher and student reports of school climate
Measured: 5 time points over 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startSep 2002
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Problem BehaviorStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 32,986 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Centers for Disease Control and Prevention, U.S. Department of Education
- Responsible party
- Sponsor
- Investigators
- Catherine P Bradshaw, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583127
- Sponsor's protocol ID
- H.33.02.03.07.A
- Other IDs
- R01MH067948
- Status last verified
- Feb 2016
- First submitted
- 20 Apr 2012
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bradshaw CP, Pas ET, Bloom J, Barrett S, Hershfeldt P, Alexander A, McKenna M, Chafin AE, Leaf PJ. A state-wide partnership to promote safe and supportive schools: the PBIS Maryland Initiative. Adm Policy Ment Health. 2012 Jul;39(4):225-37. doi: 10.1007/s10488-011-0384-6.
PubMed 22246614Bradshaw CP, Koth CW, Thornton LA, Leaf PJ. Altering school climate through school-wide Positive Behavioral Interventions and Supports: findings from a group-randomized effectiveness trial. Prev Sci. 2009 Jun;10(2):100-15. doi: 10.1007/s11121-008-0114-9.
PubMed 19011963Bradshaw, C. P., Mitchell, M. M., & Leaf, P. J. (2010). Examining the effects of School-Wide Positive Behavioral Interventions and Supports on student outcomes: Results from a randomized controlled effectiveness trial in elementary schools. Journal of Positive Behavior Interventions, 12, 133-148.
Bradshaw, C.P., Koth, C.W., Bevans, K.B., Ialongo, N., & Leaf, P.J. (2008). The impact of school-wide Positive Behavioral Interventions and Supports (PBIS) on the organizational health of elementary schools. School Psychology Quarterly, 23(4), 462-473.
Waasdorp TE, Bradshaw CP, Leaf PJ. The impact of schoolwide positive behavioral interventions and supports on bullying and peer rejection: a randomized controlled effectiveness trial. Arch Pediatr Adolesc Med. 2012 Feb;166(2):149-56. doi: 10.1001/archpediatrics.2011.755.
PubMed 22312173Stuart EA, Bradshaw CP, Leaf PJ. Assessing the generalizability of randomized trial results to target populations. Prev Sci. 2015 Apr;16(3):475-85. doi: 10.1007/s11121-014-0513-z.
PubMed 25307417Bradshaw CP, Waasdorp TE, Leaf PJ. Effects of school-wide positive behavioral interventions and supports on child behavior problems. Pediatrics. 2012 Nov;130(5):e1136-45. doi: 10.1542/peds.2012-0243. Epub 2012 Oct 15.
PubMed 23071207
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Variation in the Impact of School-Wide Positive Behavioral Interventions and Supports (PBIS)
- ClinicalTrials.gov ID
- NCT01583127
- Acronym / sponsor ID
- H.33.02.03.07.A
- Conditions
- Problem Behavior
- Keywords
- Problem Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32,986 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Centers for Disease Control and Prevention, U.S. Department of Education
- Study start
- Sep 2002
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 23 Apr 2012 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| School-Wide (SW)-PBIS intervention | Experimental | Behavioral: Positive Behavioral Interventions & SupportsSW-PBIS intervention |
| Control | No intervention | –Practice as usual |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Public Elementary Schools
- All children attending the schools and staff employed were eligible for inclusion
Key exclusion criteria (1 listed)
- None
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 Behavioral Interventions & SupportsAlso: Positive Behavior SupportsImplementation of the School-Wide Positive Behavioral Interventions and Supports model across 4 school years. | Behavioural | School-Wide (SW)-PBIS intervention |
Primary outcome
Teacher ratings
Time frame: 5 time points over 4 years
teacher ratings of students prosocial behavior, emotion regulation, conduct problems, and aggressive behavior
2 secondary outcomes
student discipline data
Time frame: 5 time points over 5 years
school climate
Time frame: 5 time points over 5 years
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 24 Feb 2016.
- Results publication: PubMed 22246614Bradshaw CP, Pas ET, Bloom J, Barrett S, Hershfeldt P, Alexander A, McKenna M, Chafin AE, Leaf PJ. A state-wide partnership to promote safe and supportive schools: the PBIS Maryland Initiative. Adm Policy Ment Health. 2012 Jul;39(4):225-37. doi: 10.1007/s10488-011-0384-6.
- Results publication: PubMed 19011963Bradshaw CP, Koth CW, Thornton LA, Leaf PJ. Altering school climate through school-wide Positive Behavioral Interventions and Supports: findings from a group-randomized effectiveness trial. Prev Sci. 2009 Jun;10(2):100-15. doi: 10.1007/s11121-008-0114-9.
- Results publicationBradshaw, C. P., Mitchell, M. M., & Leaf, P. J. (2010). Examining the effects of School-Wide Positive Behavioral Interventions and Supports on student outcomes: Results from a randomized controlled effectiveness trial in elementary schools. Journal of Positive Behavior Interventions, 12, 133-148.
- Results publicationBradshaw, C.P., Koth, C.W., Bevans, K.B., Ialongo, N., & Leaf, P.J. (2008). The impact of school-wide Positive Behavioral Interventions and Supports (PBIS) on the organizational health of elementary schools. School Psychology Quarterly, 23(4), 462-473.
- Results publication: PubMed 22312173Waasdorp TE, Bradshaw CP, Leaf PJ. The impact of schoolwide positive behavioral interventions and supports on bullying and peer rejection: a randomized controlled effectiveness trial. Arch Pediatr Adolesc Med. 2012 Feb;166(2):149-56. doi: 10.1001/archpediatrics.2011.755.
- Derived from this study: PubMed 25307417Stuart EA, Bradshaw CP, Leaf PJ. Assessing the generalizability of randomized trial results to target populations. Prev Sci. 2015 Apr;16(3):475-85. doi: 10.1007/s11121-014-0513-z.
- Derived from this study: PubMed 23071207Bradshaw CP, Waasdorp TE, Leaf PJ. Effects of school-wide positive behavioral interventions and supports on child behavior problems. Pediatrics. 2012 Nov;130(5):e1136-45. doi: 10.1542/peds.2012-0243. Epub 2012 Oct 15.
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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.
Catherine P Bradshaw, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Behavioral Interventions & Supports in people with Problem Behavior, run by Johns Hopkins Bloomberg School of Public Health at 1 site 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 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Teacher ratings (time frame: 5 time points over 4 years). 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 NCT01583127, which also lists 7 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 24 Feb 2016.