Middle SchoolsISLANCT06292078
Preventing School Exclusion and Opioid Misuse: Effectiveness of the Inclusive Skill-building Learning Approach (ISLA)
A study testing Instructional Skill-Building Learning Approach (ISLA) in people with Middle Schools and School Exclusion, run by University of Oregon at 3 sites in United States.
Trial summary
This project will test the effectiveness of the Inclusive Skill-building Learning Approach (ISLA) in reducing the use of exclusionary discipline, improving teacher practice and student outcomes, and decreasing substance misuse using a randomized controlled trial in 60 middle schools across six states. Read more about this study
- Who is it for?
- Ages 8 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Middle Schools, School Exclusion, School Community
- What is being tested?
- Instructional Skill-Building Learning Approach (ISLA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,076 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Apr 2024to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Staff member in either a control or intervention condition school
- 6th grade students in either intervention or control schools during first data collection period for each wave
Who cannot join
- None
- Cohort Students: The student cohort sample will include all students in Grade 7 during the first year of ISLA implementation, who will be followed into Grade 8 during the second year of ISLA implementation (such that data can be collected from the end of Grade 6 to the end of Grade 8). With an average middle school size of 660 students per school, we project the cohort size to be 220 students per school, for a total of 11,880 to 13,200 students.
- Sub-cohort Students: A random sample of 50 assenting 6th grade students (at the time of baseline data collection) per cohort per school will be selected to provide additional data, for a total of 2,700 to 3,000 students (consent will be gathered from parents/guardians). With the help of each school administrator, the research team will conduct the randomization process using each school's enrollment. School administrators will invite all 6th grade students to participate via recruitment emails to their parents/guardians. A random selection of students will be made from those parents who are consented.
- students who cannot complete the online survey independently (e.g., require assistance beyond text-to-speech files to comprehend the items and available responses) specifically:
- students who cannot comprehend written or spoken English or written or spoken Spanish, or
- students who are eligible for alternate assessment for statewide achievement testing.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Soquel Union Elementary School District
Capitola, California, 95010
Carissa Lemos, clemos@suesd.org
- Recruiting
Salem-Keizer School District
Salem, Oregon, 97301
Julia Dewitt, 971-599-7825
- Recruiting
Riverbend School District
Yuba City, California, 95991
Jen Cates, jcates@ycusd.org
About this study
This project will test the effectiveness of the Inclusive Skill-building Learning Approach (ISLA) in reducing the use of exclusionary discipline, improving teacher practice and student outcomes, and decreasing substance misuse using a randomized controlled trial in 60 middle schools across six states.
Read the detailed description
Extensive research has documented the link between exclusionary discipline and numerous detrimental youth outcomes including lower academic achievement, a greater likelihood of being pushed out of school, and an increase in substance use and future criminal justice involvement. To engage in upstream prevention to reduce opioid and other substance misuse among youth there is a need to examine systems-wide, preventative interventions in schools to reduce educators biased and punitive interactions with students while implementing equitable supports. Thus, "Preventing School Exclusion and Opioid Misuse: Effectiveness of the Inclusive Skillbuilding Learning Approach (ISLA)" is being submitted to the National Institutes of Health, through the HEAL Initiative (RFA-DA-23-051). The proposed project aims to evaluate the effectiveness of ISLA, an instructional and restorative alternative to exclusionary discipline, on improving the social determinants of health (SDOH) of education access and quality, and social and community context to prevent school exclusion and opioid and other substance misuse. The investigators will conduct an effectiveness-implementation Hybrid Type 1 clustered randomized controlled trial in 60 middle schools across six states. All students and educators randomized to treatment will receive ISLA, and the investigators will evaluate impacts of ISLA on student outcomes from the end of 6th to the end of 8th grade. In addition, the investigators will incorporate methods to understand intervention processes across multiple levels of the school context. Our first aim is to examine the effectiveness of the ISLA. The investigators will test the direct effects of ISLA on the SDOH of education access and quality, specifically: (a) exclusionary discipline practices (office discipline referrals, in- and out-of-school suspensions, expulsions); (b) student engagement; and (c) inclusive teaching practices. The investigators will also test the direct effects of ISLA on the SDOH of social and community context, specifically: (a) student-teacher relationships; and (b) school climate. Additionally, the investigators will test the direct effects of ISLA on opioid and other substance misuse and associated risk factors. Our second aim is to examine the mediators and moderators of ISLA intervention effects which serve as key mechanisms for change in opioid and other substance misuse and associated risk factors. The investigators will examine the putative mediating effects of ISLA social determinant mechanisms on opioid and other substance misuse and associated risk factors. The investigators will also examine the potential moderating effect between student race/ethnicity and the ISLA intervention on reductions in exclusionary disciplinary practices. Finally, our third aim is to evaluate the implementation outcomes of the ISLA intervention, including: (a) feasibility, usability, acceptability, and fidelity; (b) sustainment; and (c) cost analysis. This project will fill a persistent gap in the field of substance use, by evaluating whether upstream school-based preventative interventions that target and improve SDOH can have meaningful impacts on preventing opioid and other substance misuse and associated risk factors.
- Conditions
- Middle Schools, School Exclusion, School Community, Teaching Practices, Opioid and Other Substance Misuse
- Being tested
- Instructional Skill-Building Learning Approach (ISLA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instructional Skill-Building Learning Approach (ISLA)Behavioural
The Inclusive Skill-building Learning Approach (ISLA) is a school-wide, multi-component, instructional and restorative alternative to exclusionary discipline that begins with universal prevention grounded in positive, preventative classroom strategies for all students, and layers on additional supports for students in need.
| Study group | Role | What they receive |
|---|---|---|
| Wave 1 Instructional Skill-Building Learning Approach (ISLA) | Experimental | Following a baseline year for data collection, school staff in 15 schools will be trained and supported in implementing ISLA schoolwide for two consecutive years. Receives: Behavioral: Instructional Skill-Building Learning Approach (ISLA) |
| Wave 1 Waitlist Control | No intervention | These 15 schools will receive no intervention while wave 1 intervention schools undergo training and coaching on ISLA. |
| Wave 2 Instructional Skill-Building Learning Approach (ISLA) | Experimental | Delayed one year after wave 1: Following a baseline year for data collection, school staff in 15 schools will be trained and supported in implementing ISLA schoolwide for two consecutive years. Receives: Behavioral: Instructional Skill-Building Learning Approach (ISLA) |
| Wave 2 Waitlist Control | No intervention | These 15 schools will receive no intervention while wave 2 intervention schools undergo training and coaching on ISLA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and Duration of Use of Office Discipline Referrals, In-School Suspension, and Out-of-School Suspension
We will collect data on the use of office discipline referrals (ODRs), in-school (ISS), and out-of-school suspensions (OSS). As part of the National TA Center on PBIS, all schools that will be recruited for this project use the School-Wide Information Systems (SWIS; May et al., 2013), a web-based behavior tracking platform, to enter and review behavior incidents and actions taken by school personnel including office discipline referrals (ODRs), in-school (ISS), and out-of-school suspensions (OSS).
Measured: baseline, 1 year, 2 years
Engagement vs. Disaffection with Learning Student-report
The Engagement vs. Disaffection with Learning Student-report assesses engagement as a key component of motivated action leading to student learning and achievement. The assessment measures engagement versus disaffection in the classroom ranging from enthusiastic, effortful, emotionally positive interactions with learning activities to apathetic withdrawal and frustrated alienation, with both positive manifestations of behavioral and emotional participation in classroom and withdrawal of behavioral and emotional participation and alienation from learning. All items have five response options: (1) Not at all True; (2) A little True; (3) Mostly True; (4) Very True; (5) Prefer not to answer.
Measured: baseline, 1 year, 2 years
Inclusive Teaching Practices
The WOW+ (Welcome at the door, Own your environment, Wrap up with intention +) Self-Report measures inclusive teaching practices, both general and specific teaching strategies that are part of the ISLA intervention. All school personnel in all treatment schools will receive training on the ISLA strategy for universal relationship building, known as the WOW strategy, which consists of three concrete skills rooted in behavioral science that educators can apply every day to create positive classroom environments: welcome students, own your classroom environment, and wrap up class with the intention. The WOW+ Self-Report is an adaption of the WOW Classroom Observation Tool which is a five-item measure with individual item scores ranging from 0 to 2, where each item is an operationally defined behavior based on the elements of the WOW strategy training.
Measured: baseline, 1 year, 2 years
School Climate Survey- Student
The School Climate Survey: Secondary (SCS-S) is a 36-item, computerized school climate rating scale (Center on PBIS, 2022). The purpose of the SCS-S is to obtain middle and high school student perception ratings of school climate. Respondents use a 4-point Likert scale: 1=Strongly Disagree, 2 = Disagree, 3 = Agree, and 4 = Strongly Agree. To compute the overall school climate score, item responses are summed and then divided by the total number of items. Higher overall scores reflect a positive sense of the school environment with respect to (a) interpersonal relations among and between peers and adults, (b) learning environment, and (c) feelings of belonging and acceptance.
Measured: baseline, 1 year, 2 years
School Climate- Teacher
The School Climate Survey: School Personnel (Center on PBIS, 2022) includes 29 items and 5 subscales, including staff connectedness, structure for learning, school safety, physical environment, peer and adult relations, and parent involvement. School personnel rate items as Strongly Agree, Somewhat Disagree, Somewhat Agree or Strongly Agree. The personnel survey also demonstrates adequate psychometric properties with an internal consistency of .94 for the overall school climate scale.
Measured: baseline, 1 year, 2 years
Student-Teacher Relationships
The Adult Social Support subscale from the School Climate Survey: Student (SCS-S; Center on PBIS, 2022) will be used to measure student-teacher relationships in schools. The Adult Social Support subscale contains four items and has strong internal consistency (α = .91). A high mean score on the Adult Social Support subscale represents a positive feeling of adult support and encouragement, whereas a low score suggests poor interpersonal relationships among students and adults within the school. From this subscale, we expect to understand data about student engagement, school climate, opioid and other substance misuse, internalizing and externalizing behaviors.
Measured: baseline, 1 year, 2 years
Opioid and Other Substance Misuse
Thirteen opioid and other substance misuse questions and response criteria are derived from the Monitoring the Future survey conducted annually with adolescent youth throughout the United States and the National Institute on Drug Abuse-modified Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) measure. The survey is funded by NIDA as an on-going surveillance effort to understand and report substance use trends among youth. Respondents use an ordinal response scale with seven options (0 Occasions; 1-2; 3-5; 6-9; 10-19; 20-39; 40 or more) to describe substance use during the last 12 months.
Measured: baseline, 1 year, 2 years
Student Internalizing Behaviors
The Strengths and Difficulties Questionnaire (SDQ; Goodman 1997) is a brief (25 items) behavioral screening questionnaire about psychosocial problems for youth, and includes competencies or strengths in addition to assessing problems. The SDQ is equally divided across five scales measuring emotional symptoms, conduct problems, hyperactivity-inattention, peer problems, and prosocial behavior. Participants rate items as Not True, Somewhat True, or Certainly True. The SDQ has adequate psychometric properties with internal consistency of .68 and test-retest reliability of .62.
Measured: baseline, 1 year, 2 years
Student Externalizing Behaviors
Nine items from the Youth Self-Report (YSR; Achenbach, 1991) will be used to measure student externalizing behaviors. The YSR asks students now or within the past 6 months, how often they had the following problems: Hangs around bad kids; Swears; Uses alcohol or drugs; Truant; Runs away; Lies or cheats; Prefers older kids; Doesn't feel guilty. Each item has three categories: 0 = not true or not at all, 1 = sometimes or somewhat true, or 2 = very true or often. The internal consistency of these items was α = .68 (Song et al., 1994).
Measured: baseline, 1 year, 2 years
ISLA Acceptability
The Primary Intervention Rating Scale (PIRS) will be used as a measure of the feasibility, usability, and acceptability of the ISLA intervention by gathering educator perceptions of the social validity of intervention goals and procedures (Lane et al., 2002). The PIRS is a 17-item survey completed on a Likert scale with allowable responses of Strongly Disagree, Disagree, Slightly Disagree, Slightly Agree, Agree, and Strongly Agree. The PIRS has adequate psychometric properties, with internal consistency of .97, and the correlation between schools' PIRS scores and treatment integrity scores was r = .71 (Lane et al., 2009). To the PIRS we have added two items relating to sustainment, and four open-ended items that have been applied in previous research (Furjanic et al., 2021).
Measured: 1 year and 2 years for intervention condition schools
ISLA Implementation Fidelity
The fidelity if ISLA implementation will be measured using student-level ISLA fidelity tracking sheets (maintained by the ISLA support staff member in each school), and the school-wide ISLA Implementation Checklist (completed by the school team). The ISLA fidelity tracking sheet is used to record information about each student that accesses the ISLA support room, and the ISLA support staff completes Yes/No questions about ISLA delivery for each student.
Measured: baseline, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start15 Apr 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Middle SchoolsStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5,076 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292078
- Sponsor's protocol ID
- 1R01DA059401-01
- Other IDs
- 1R01DA059401-01
- Acronym
- ISLA
- Status last verified
- Oct 2026
- First submitted
- 15 Feb 2024
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing School Exclusion and Opioid Misuse: Effectiveness of the Inclusive Skill-building Learning Approach (ISLA)
- ClinicalTrials.gov ID
- NCT06292078
- Acronym / sponsor ID
- ISLA / 1R01DA059401-01
- Conditions
- Middle Schools, School Exclusion, School Community, Teaching Practices, Opioid and Other Substance Misuse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,076 participants (estimated)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 4 Mar 2024 (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.
This project will test the effectiveness of the Inclusive Skill-building Learning Approach (ISLA) in reducing the use of exclusionary discipline, improving teacher practice and student outcomes, and decreasing substance misuse using a randomized controlled trial in 60 middle schools across six states.
Detailed description
Extensive research has documented the link between exclusionary discipline and numerous detrimental youth outcomes including lower academic achievement, a greater likelihood of being pushed out of school, and an increase in substance use and future criminal justice involvement. To engage in upstream prevention to reduce opioid and other substance misuse among youth there is a need to examine systems-wide, preventative interventions in schools to reduce educators biased and punitive interactions with students while implementing equitable supports. Thus, "Preventing School Exclusion and Opioid Misuse: Effectiveness of the Inclusive Skillbuilding Learning Approach (ISLA)" is being submitted to the National Institutes of Health, through the HEAL Initiative (RFA-DA-23-051). The proposed project aims to evaluate the effectiveness of ISLA, an instructional and restorative alternative to exclusionary discipline, on improving the social determinants of health (SDOH) of education access and quality, and social and community context to prevent school exclusion and opioid and other substance misuse. The investigators will conduct an effectiveness-implementation Hybrid Type 1 clustered randomized controlled trial in 60 middle schools across six states. All students and educators randomized to treatment will receive ISLA, and the investigators will evaluate impacts of ISLA on student outcomes from the end of 6th to the end of 8th grade. In addition, the investigators will incorporate methods to understand intervention processes across multiple levels of the school context. Our first aim is to examine the effectiveness of the ISLA. The investigators will test the direct effects of ISLA on the SDOH of education access and quality, specifically: (a) exclusionary discipline practices (office discipline referrals, in- and out-of-school suspensions, expulsions); (b) student engagement; and (c) inclusive teaching practices. The investigators will also test the direct effects of ISLA on the SDOH of social and community context, specifically: (a) student-teacher relationships; and (b) school climate. Additionally, the investigators will test the direct effects of ISLA on opioid and other substance misuse and associated risk factors. Our second aim is to examine the mediators and moderators of ISLA intervention effects which serve as key mechanisms for change in opioid and other substance misuse and associated risk factors. The investigators will examine the putative mediating effects of ISLA social determinant mechanisms on opioid and other substance misuse and associated risk factors. The investigators will also examine the potential moderating effect between student race/ethnicity and the ISLA intervention on reductions in exclusionary disciplinary practices. Finally, our third aim is to evaluate the implementation outcomes of the ISLA intervention, including: (a) feasibility, usability, acceptability, and fidelity; (b) sustainment; and (c) cost analysis. This project will fill a persistent gap in the field of substance use, by evaluating whether upstream school-based preventative interventions that target and improve SDOH can have meaningful impacts on preventing opioid and other substance misuse and associated risk factors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Wave 1 Instructional Skill-Building Learning Approach (ISLA) | Experimental | Behavioral: Instructional Skill-Building Learning Approach (ISLA)Following a baseline year for data collection, school staff in 15 schools will be trained and supported in implementing ISLA schoolwide for two consecutive years. |
| Wave 1 Waitlist Control | No intervention | –These 15 schools will receive no intervention while wave 1 intervention schools undergo training and coaching on ISLA. |
| Wave 2 Instructional Skill-Building Learning Approach (ISLA) | Experimental | Behavioral: Instructional Skill-Building Learning Approach (ISLA)Delayed one year after wave 1: Following a baseline year for data collection, school staff in 15 schools will be trained and supported in implementing ISLA schoolwide for two consecutive years. |
| Wave 2 Waitlist Control | No intervention | –These 15 schools will receive no intervention while wave 2 intervention schools undergo training and coaching on ISLA. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
Key exclusion criteria (6 listed)
- Cohort Students: The student cohort sample will include all students in Grade 7 during the first year of ISLA implementation, who will be followed into Grade 8 during the second year of ISLA implementation (such that data can be collected from the end of Grade 6 to the end of Grade 8). With an average middle school size of 660 students per school, we project the cohort size to be 220 students per school, for a total of 11,880 to 13,200 students.
- Sub-cohort Students: A random sample of 50 assenting 6th grade students (at the time of baseline data collection) per cohort per school will be selected to provide additional data, for a total of 2,700 to 3,000 students (consent will be gathered from parents/guardians). With the help of each school administrator, the research team will conduct the randomization process using each school's enrollment. School administrators will invite all 6th grade students to participate via recruitment emails to their parents/guardians. A random selection of students will be made from those parents who are consented.
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 |
|---|---|---|
| Instructional Skill-Building Learning Approach (ISLA)The Inclusive Skill-building Learning Approach (ISLA) is a school-wide, multi-component, instructional and restorative alternative to exclusionary discipline that begins with universal prevention grounded in positive, preventative classroom strategies for all students, and layers on additional supports for students in need. | Behavioural | Wave 1 Instructional Skill-Building Learning Approach (ISLA), Wave 2 Instructional Skill-Building Learning Approach (ISLA) |
Primary outcome
Frequency and Duration of Use of Office Discipline Referrals, In-School Suspension, and Out-of-School Suspension
Time frame: baseline, 1 year, 2 years
We will collect data on the use of office discipline referrals (ODRs), in-school (ISS), and out-of-school suspensions (OSS). As part of the National TA Center on PBIS, all schools that will be recruited for this project use the School-Wide Information Systems (SWIS; May et al., 2013), a web-based behavior tracking platform, to enter and review behavior incidents and actions taken by school personnel including office discipline referrals (ODRs), in-school (ISS), and out-of-school suspensions (OSS).
Engagement vs. Disaffection with Learning Student-report
Time frame: baseline, 1 year, 2 years
The Engagement vs. Disaffection with Learning Student-report assesses engagement as a key component of motivated action leading to student learning and achievement. The assessment measures engagement versus disaffection in the classroom ranging from enthusiastic, effortful, emotionally positive interactions with learning activities to apathetic withdrawal and frustrated alienation, with both positive manifestations of behavioral and emotional participation in classroom and withdrawal of behavioral and emotional participation and alienation from learning. All items have five response options: (1) Not at all True; (2) A little True; (3) Mostly True; (4) Very True; (5) Prefer not to answer.
Inclusive Teaching Practices
Time frame: baseline, 1 year, 2 years
The WOW+ (Welcome at the door, Own your environment, Wrap up with intention +) Self-Report measures inclusive teaching practices, both general and specific teaching strategies that are part of the ISLA intervention. All school personnel in all treatment schools will receive training on the ISLA strategy for universal relationship building, known as the WOW strategy, which consists of three concrete skills rooted in behavioral science that educators can apply every day to create positive classroom environments: welcome students, own your classroom environment, and wrap up class with the intention. The WOW+ Self-Report is an adaption of the WOW Classroom Observation Tool which is a five-item measure with individual item scores ranging from 0 to 2, where each item is an operationally defined behavior based on the elements of the WOW strategy training.
School Climate Survey- Student
Time frame: baseline, 1 year, 2 years
The School Climate Survey: Secondary (SCS-S) is a 36-item, computerized school climate rating scale (Center on PBIS, 2022). The purpose of the SCS-S is to obtain middle and high school student perception ratings of school climate. Respondents use a 4-point Likert scale: 1=Strongly Disagree, 2 = Disagree, 3 = Agree, and 4 = Strongly Agree. To compute the overall school climate score, item responses are summed and then divided by the total number of items. Higher overall scores reflect a positive sense of the school environment with respect to (a) interpersonal relations among and between peers and adults, (b) learning environment, and (c) feelings of belonging and acceptance.
School Climate- Teacher
Time frame: baseline, 1 year, 2 years
The School Climate Survey: School Personnel (Center on PBIS, 2022) includes 29 items and 5 subscales, including staff connectedness, structure for learning, school safety, physical environment, peer and adult relations, and parent involvement. School personnel rate items as Strongly Agree, Somewhat Disagree, Somewhat Agree or Strongly Agree. The personnel survey also demonstrates adequate psychometric properties with an internal consistency of .94 for the overall school climate scale.
Student-Teacher Relationships
Time frame: baseline, 1 year, 2 years
The Adult Social Support subscale from the School Climate Survey: Student (SCS-S; Center on PBIS, 2022) will be used to measure student-teacher relationships in schools. The Adult Social Support subscale contains four items and has strong internal consistency (α = .91). A high mean score on the Adult Social Support subscale represents a positive feeling of adult support and encouragement, whereas a low score suggests poor interpersonal relationships among students and adults within the school. From this subscale, we expect to understand data about student engagement, school climate, opioid and other substance misuse, internalizing and externalizing behaviors.
Opioid and Other Substance Misuse
Time frame: baseline, 1 year, 2 years
Thirteen opioid and other substance misuse questions and response criteria are derived from the Monitoring the Future survey conducted annually with adolescent youth throughout the United States and the National Institute on Drug Abuse-modified Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) measure. The survey is funded by NIDA as an on-going surveillance effort to understand and report substance use trends among youth. Respondents use an ordinal response scale with seven options (0 Occasions; 1-2; 3-5; 6-9; 10-19; 20-39; 40 or more) to describe substance use during the last 12 months.
Student Internalizing Behaviors
Time frame: baseline, 1 year, 2 years
The Strengths and Difficulties Questionnaire (SDQ; Goodman 1997) is a brief (25 items) behavioral screening questionnaire about psychosocial problems for youth, and includes competencies or strengths in addition to assessing problems. The SDQ is equally divided across five scales measuring emotional symptoms, conduct problems, hyperactivity-inattention, peer problems, and prosocial behavior. Participants rate items as Not True, Somewhat True, or Certainly True. The SDQ has adequate psychometric properties with internal consistency of .68 and test-retest reliability of .62.
Student Externalizing Behaviors
Time frame: baseline, 1 year, 2 years
Nine items from the Youth Self-Report (YSR; Achenbach, 1991) will be used to measure student externalizing behaviors. The YSR asks students now or within the past 6 months, how often they had the following problems: Hangs around bad kids; Swears; Uses alcohol or drugs; Truant; Runs away; Lies or cheats; Prefers older kids; Doesn't feel guilty. Each item has three categories: 0 = not true or not at all, 1 = sometimes or somewhat true, or 2 = very true or often. The internal consistency of these items was α = .68 (Song et al., 1994).
ISLA Acceptability
Time frame: 1 year and 2 years for intervention condition schools
The Primary Intervention Rating Scale (PIRS) will be used as a measure of the feasibility, usability, and acceptability of the ISLA intervention by gathering educator perceptions of the social validity of intervention goals and procedures (Lane et al., 2002). The PIRS is a 17-item survey completed on a Likert scale with allowable responses of Strongly Disagree, Disagree, Slightly Disagree, Slightly Agree, Agree, and Strongly Agree. The PIRS has adequate psychometric properties, with internal consistency of .97, and the correlation between schools' PIRS scores and treatment integrity scores was r = .71 (Lane et al., 2009). To the PIRS we have added two items relating to sustainment, and four open-ended items that have been applied in previous research (Furjanic et al., 2021).
ISLA Implementation Fidelity
Time frame: baseline, 1 year, 2 years
The fidelity if ISLA implementation will be measured using student-level ISLA fidelity tracking sheets (maintained by the ISLA support staff member in each school), and the school-wide ISLA Implementation Checklist (completed by the school team). The ISLA fidelity tracking sheet is used to record information about each student that accesses the ISLA support room, and the ISLA support staff completes Yes/No questions about ISLA delivery for each student.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instructional Skill-Building Learning Approach (ISLA) in people with Middle Schools and School Exclusion, run by University of Oregon at 3 sites 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 6 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: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sean C Austin, PhD ((541) 346-0464, seana@uoregon.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and Duration of Use of Office Discipline Referrals, In-School Suspension, and Out-of-School Suspension (time frame: baseline, 1 year, 2 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2026.