Substance AbuseNCT04711681
Implementing School Wide PBS in Middle Schools: The Foundation for Effective Prevention
A study testing Positive Behavior Supports in Middle Schools in people with Substance Abuse and Mental Health, run by University of Oregon at 1 site in United States.
Trial summary
The research study will experimentally evaluate the impact of PBS on early adolescent development through a randomized control trial involving 36 middle schools. The impact of PBS on school staff discipline practices and student behavior will be evaluated. Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse, Mental Health
- What is being tested?
- Positive Behavior Supports in Middle Schools
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,498 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to 24 Mar 2015
- 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 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All students and teachers in the school
Who cannot join
- Any students or teachers who decline consent (passive or active)
Trial locations and contacts
1 site in 1 country.
About this study
The research study will experimentally evaluate the impact of PBS on early adolescent development through a randomized control trial involving 36 middle schools. The impact of PBS on school staff discipline practices and student behavior will be evaluated. The study will examine whether the likely reductions in negative behavior in school are accompanied by reductions in peer harassment and victimization, peer rejection, deviant peer formation, and the development of antisocial behavior, substance use, high risk sexual behavior, and depression.
Read the detailed description
The specific aims for the project are as follows:
- Evaluate the effects of the PBS intervention in a group-randomized trial in which middle schools are assigned to receive systematic training and consultation in the implementation of PBS or a one-day workshop on PBS (the control group).
- The PBS intervention group is expected to improve school behavior management practices compared to the control group.
- School climate is expected to improve in the PBS intervention group compared to the control group.
- Problem behaviors and deviant peer group formation are expected to decrease for students in the PBS intervention group compared to those in the control group.
- The development of problem behavior in later adolescence is expected to be lessened for the PBS intervention students compared to those in the control group. The effects of the intervention will be assessed through staff, student, and observer reports of discipline practices in schools. The investigators will assess changes in the frequency of in-school problem behaviors as measured by student reports, office discipline referrals, and out-of-school suspensions. Measures of student and teacher perception of the quality of school climate will include student reports of harassment and teacher reports of burnout. Formation of deviant peer groups will be assessed through student reports of their peer affiliation. Finally, adolescents' development of problems will be assessed over as many as five years through annual surveys of antisocial behavior, substance use, high risk sexual behavior, and depression.
- Assess the differential impact of intervention fidelity on targeted outcomes. No real-world implementation of a preventive intervention can be expected to be implemented with perfect fidelity in every school. The study will:
- Assess the degree of fidelity of implementation of all PBS intervention aspects.
- Examine the relationship of fidelity to changes in each of the targeted outcomes: discipline practices, in-school problem behavior, peer relations, deviant peer group formation, and adolescent problems.
- Provide further information about the specific facets of PBS associated with particular outcomes.
- To the extent that fidelity is related to outcome, above the simple relationship between condition assignment and outcome, it will strengthen the investigators confidence in the efficacy of PBS practices.
- Test a model of the influence of middle school discipline practices on the development of adolescent problems. The model, which is specified in Figure 1 and the following pages, posits that:
- Inadequate behavior management practices in middle schools contribute to aggressive and disruptive behavior among students in those schools.
- Schools with high levels of aggression and harassment make the formation of deviant peer groups more likely.
- Escalating aggressive behavior, harassment, and deviant peer group formation then contribute to the development of a range of problems in both school and non-school settings including antisocial behavior, substance use, depression, and high risk sexual behavior. The model will be tested using state of the art hierarchical linear modeling (e.g., Singer \& Willett, 2003).
- Assess the maintenance of the PBS intervention after termination of training and technical assistance. It is unlikely that effective behavior management will be implemented and maintained, unless the school-as an organization-has adopted a system that is supported by all staff and used in every setting (Gottfredson, Gottfredson \& Czeh, 2000; Sprague, Walker, Golly et al., 2001). Research is needed, however, on the extent to which the PBS system, once implemented is maintained. The present project will provide evidence about the degree to which PBS is maintained and identify the school characteristics that are associated with its maintenance.
- Assess the relationship of Office Discipline Referral data to adolescents' reports of their engagement in diverse problems. Office Discipline Referrals (ODR) have been widely used to evaluate PBS interventions. PBS typically produces substantial reductions in ODR's (e.g., Metzler, Biglan, et al. 2001; Taylor-Green et al., 1997; Sprague, Walker, Golly, White \& Myers, 2001). However, little is known about the relationship between the ODR measure and other measures of adolescent problems (Irvin, Tobin, Sprague, Sugai, \& Vincent, 2004). The proposed project will:
- Assess the validity of the ODR by examining both the concurrent and longitudinal relationships of the ODR with student self-report measures of problems.
- Examine the significance of reductions in ODR's for PBS intervention schools and students.
- Conditions
- Substance Abuse, Mental Health
- Being tested
- Positive Behavior Supports in Middle Schools
- Keywords
- Randomized Controlled Trials, Behavioral Research
- Medical subject headings
- Substance-Related Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Behavior Supports in Middle SchoolsBehavioural
2-4 days SWPBS training for school team and 1-2 days for whole staff training (SW and Classroom Management). Use staff release days for whole staff training.
Schedule up to four meetings with the PBS team
1K/School is to fund part or whole day training meeting with PBS team Schedule whole staff training per school year staff release days Enhanced Intervention Family Support Universal -- parent education and invitation Selective -- Family Check up School Intervention ACT for teachers PBS Calendar Kernel Recipes (Treatment) Reminder Emails Brochures Weekly phone contact (Treatment)
Positive Behavior Supports in Middle SchoolsBehavioural
1 days PBS training for school team and informational presentation to whole staff Attend 2-3 PBS team meetings (coaching) Data-based feedback (limited)
| Study group | Role | What they receive |
|---|---|---|
| PBS1 | Experimental | This group will recieve an "enhanced" PBS intervention. Receives: Behavioral: Positive Behavior Supports in Middle Schools |
| PBS 2 | Active comparator | This group will receive "standard" PBS with fewer training and coaching sessions than PBS 1. Receives: Behavioral: Positive Behavior Supports in Middle Schools |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antisocial behavior Depression Disruptive behavior Deviant peer association Student feelings of safety
Measured: Four years
Peer to Peer Harassment
Measured: Four Years
Direct observation of rates of problem behavior, teacher-student interactions in common areas and classrooms. Ratings of climate in randomly selected classrooms.
Measured: Four Years
Secondary outcomes (3)
Office Discipline Referrals
Measured: Four Years
School demographics (size, racial makeup, academic achievement scores, attendance)
Measured: Four years
Suspensions and expulsions
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study startAug 2006
- Primary completion24 Mar 2015
- Study completion24 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies 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
- Model description
- This study aimed to experimentally evaluate the impact of school wide Positive Behavior Interventions and Supports (SWPBIS) on early adolescent development through a randomized control trial involving 35 middle schools in the Pacific Northwest. The impact of two levels of SWPBIS training and technical assistance on school discipline practices and student behavior was evaluated.
- Masking
- None (open label)
- Enrolment
- 13,498 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Oregon Research Institute
- Responsible party
- Sponsor
- Investigators
- Jeffrey R Sprague, Ph.D., Principal investigator, University of OregonJulie C Rusby, Ph.D., Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711681
- Sponsor's protocol ID
- 1R01DA019037-01A1
- Status last verified
- Jan 2021
- First submitted
- 24 Mar 2014
- Last updated
- 15 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Biglan, A., Ross, S., & Sprague, J. (2009). The role of Experiential Avoidance in the wellbeing of middle school teachers. Manuscript in preparation.
Rusby JC, Crowley R, Sprague J, Biglan A. OBSERVATIONS OF THE MIDDLE-SCHOOL ENVIRONMENT: THE CONTEXT FOR STUDENT BEHAVIOR BEYOND THE CLASSROOM. Psychol Sch. 2011 Apr;48(4):10.1002/pits.20562. doi: 10.1002/pits.20562. No abstract available.
PubMed 24363461Sprague, J., Stieber, S., Smith, S. Rusby, J., & Biglan, A. (in preparation). An analysis of two methods for assessing intervention fidelity of School-Wide PBS. Eugene, OR: University of Oregon.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing School Wide PBS in Middle Schools: The Foundation for Effective Prevention
- ClinicalTrials.gov ID
- NCT04711681
- Acronym / sponsor ID
- 1R01DA019037-01A1
- Conditions
- Substance Abuse, Mental Health
- Keywords
- Randomized Controlled Trials, Behavioral Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13,498 participants (actual)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Oregon Research Institute
- Study start
- Aug 2006 (actual)
- Primary completion
- 24 Mar 2015 (actual)
- Study completion
- 24 Mar 2015 (actual)
- First posted
- 15 Jan 2021 (actual)
- 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 research study will experimentally evaluate the impact of PBS on early adolescent development through a randomized control trial involving 36 middle schools. The impact of PBS on school staff discipline practices and student behavior will be evaluated. The study will examine whether the likely reductions in negative behavior in school are accompanied by reductions in peer harassment and victimization, peer rejection, deviant peer formation, and the development of antisocial behavior, substance use, high risk sexual behavior, and depression.
Detailed description
The specific aims for the project are as follows:
- Evaluate the effects of the PBS intervention in a group-randomized trial in which middle schools are assigned to receive systematic training and consultation in the implementation of PBS or a one-day workshop on PBS (the control group).
- The PBS intervention group is expected to improve school behavior management practices compared to the control group.
- School climate is expected to improve in the PBS intervention group compared to the control group.
- Problem behaviors and deviant peer group formation are expected to decrease for students in the PBS intervention group compared to those in the control group.
- The development of problem behavior in later adolescence is expected to be lessened for the PBS intervention students compared to those in the control group. The effects of the intervention will be assessed through staff, student, and observer reports of discipline practices in schools. The investigators will assess changes in the frequency of in-school problem behaviors as measured by student reports, office discipline referrals, and out-of-school suspensions. Measures of student and teacher perception of the quality of school climate will include student reports of harassment and teacher reports of burnout. Formation of deviant peer groups will be assessed through student reports of their peer affiliation. Finally, adolescents' development of problems will be assessed over as many as five years through annual surveys of antisocial behavior, substance use, high risk sexual behavior, and depression.
- Assess the differential impact of intervention fidelity on targeted outcomes. No real-world implementation of a preventive intervention can be expected to be implemented with perfect fidelity in every school. The study will:
- Assess the degree of fidelity of implementation of all PBS intervention aspects.
- Examine the relationship of fidelity to changes in each of the targeted outcomes: discipline practices, in-school problem behavior, peer relations, deviant peer group formation, and adolescent problems.
- Provide further information about the specific facets of PBS associated with particular outcomes.
- To the extent that fidelity is related to outcome, above the simple relationship between condition assignment and outcome, it will strengthen the investigators confidence in the efficacy of PBS practices.
- Test a model of the influence of middle school discipline practices on the development of adolescent problems. The model, which is specified in Figure 1 and the following pages, posits that:
- Inadequate behavior management practices in middle schools contribute to aggressive and disruptive behavior among students in those schools.
- Schools with high levels of aggression and harassment make the formation of deviant peer groups more likely.
- Escalating aggressive behavior, harassment, and deviant peer group formation then contribute to the development of a range of problems in both school and non-school settings including antisocial behavior, substance use, depression, and high risk sexual behavior. The model will be tested using state of the art hierarchical linear modeling (e.g., Singer \& Willett, 2003).
- Assess the maintenance of the PBS intervention after termination of training and technical assistance. It is unlikely that effective behavior management will be implemented and maintained, unless the school-as an organization-has adopted a system that is supported by all staff and used in every setting (Gottfredson, Gottfredson \& Czeh, 2000; Sprague, Walker, Golly et al., 2001). Research is needed, however, on the extent to which the PBS system, once implemented is maintained. The present project will provide evidence about the degree to which PBS is maintained and identify the school characteristics that are associated with its maintenance.
- Assess the relationship of Office Discipline Referral data to adolescents' reports of their engagement in diverse problems. Office Discipline Referrals (ODR) have been widely used to evaluate PBS interventions. PBS typically produces substantial reductions in ODR's (e.g., Metzler, Biglan, et al. 2001; Taylor-Green et al., 1997; Sprague, Walker, Golly, White \& Myers, 2001). However, little is known about the relationship between the ODR measure and other measures of adolescent problems (Irvin, Tobin, Sprague, Sugai, \& Vincent, 2004). The proposed project will:
- Assess the validity of the ODR by examining both the concurrent and longitudinal relationships of the ODR with student self-report measures of problems.
- Examine the significance of reductions in ODR's for PBS intervention schools and students.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study aimed to experimentally evaluate the impact of school wide Positive Behavior Interventions and Supports (SWPBIS) on early adolescent development through a randomized control trial involving 35 middle schools in the Pacific Northwest. The impact of two levels of SWPBIS training and technical assistance on school discipline practices and student behavior was evaluated.
| Arm | Type | Receives |
|---|---|---|
| PBS1 | Experimental | Behavioral: Positive Behavior Supports in Middle SchoolsThis group will recieve an "enhanced" PBS intervention. |
| PBS 2 | Active comparator | Behavioral: Positive Behavior Supports in Middle SchoolsThis group will receive "standard" PBS with fewer training and coaching sessions than PBS 1. |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All students and teachers in the school
Key exclusion criteria (1 listed)
- Any students or teachers who decline consent (passive or active)
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 Behavior Supports in Middle Schools2-4 days SWPBS training for school team and 1-2 days for whole staff training (SW and Classroom Management). Use staff release days for whole staff training. Schedule up to four meetings with the PBS team 1K/School is to fund part or whole day training meeting with PBS team Schedule whole staff training per school year staff release days Enhanced Intervention Family Support Universal -- parent education and invitation Selective -- Family Check up School Intervention ACT for teachers PBS Calendar Kernel Recipes (Treatment) Reminder Emails Brochures Weekly phone contact (Treatment) | Behavioural | PBS1 |
| Positive Behavior Supports in Middle Schools1 days PBS training for school team and informational presentation to whole staff Attend 2-3 PBS team meetings (coaching) Data-based feedback (limited) | Behavioural | PBS 2 |
Primary outcome
Antisocial behavior Depression Disruptive behavior Deviant peer association Student feelings of safety
Time frame: Four years
Peer to Peer Harassment
Time frame: Four Years
Direct observation of rates of problem behavior, teacher-student interactions in common areas and classrooms. Ratings of climate in randomly selected classrooms.
Time frame: Four Years
3 secondary outcomes
Office Discipline Referrals
Time frame: Four Years
School demographics (size, racial makeup, academic achievement scores, attendance)
Time frame: Four years
Suspensions and expulsions
Time frame: Four 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 15 Jan 2021.
- BackgroundBiglan, A., Ross, S., & Sprague, J. (2009). The role of Experiential Avoidance in the wellbeing of middle school teachers. Manuscript in preparation.
- Background: PubMed 24363461Rusby JC, Crowley R, Sprague J, Biglan A. OBSERVATIONS OF THE MIDDLE-SCHOOL ENVIRONMENT: THE CONTEXT FOR STUDENT BEHAVIOR BEYOND THE CLASSROOM. Psychol Sch. 2011 Apr;48(4):10.1002/pits.20562. doi: 10.1002/pits.20562. No abstract available.
- BackgroundSprague, J., Stieber, S., Smith, S. Rusby, J., & Biglan, A. (in preparation). An analysis of two methods for assessing intervention fidelity of School-Wide PBS. Eugene, OR: University of Oregon.
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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.
Jeffrey R Sprague, Ph.D. principal investigator
University of Oregon
Julie C Rusby, Ph.D. principal investigator
Oregon Research Institute
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 Behavior Supports in Middle Schools in people with Substance Abuse and Mental Health, run by University of Oregon 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 1 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 15 Jan 2021. 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?
Antisocial behavior Depression Disruptive behavior Deviant peer association Student feelings of safety (time frame: Four years). 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 NCT04711681, which also lists 3 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 15 Jan 2021.