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NCT06292078 · University of Oregon

Preventing School Exclusion and Opioid Misuse: Effectiveness of the Inclusive Skill-building Learning Approach (ISLA)

(ISLA)

What this study is about

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 randomly assigned controlled trial in 60 middle schools across six states.

View original scientific description

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.

Interventions

BEHAVIORAL

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.

Primary outcome measures

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Staff member in either a control or intervention condition school *

Exclusion criteria

  • 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.
  • 6th grade students in either intervention or control schools during first data collection period for each wave
  • 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.

Where

  • Capitola, California
  • Yuba City, California
  • Salem, Oregon

Collaborators

National Institute on Drug Abuse (NIDA)

Related conditions & keywords

Middle SchoolsSchool ExclusionSchool CommunityTeaching PracticesOpioid and Other Substance Misuse

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced May 22, 2026 · Source of record for eligibility and locations

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Capitola

California

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Yuba City

California

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Salem

Oregon

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View Salem location page

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Middle Schools Treatment Options in Capitola, California

If you're searching for Middle Schools treatment in Capitola, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Capitola, Yuba City, Salem and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Middle Schools. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 5076 participants
Quick Start
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Why Consider a Clinical Trial for Middle Schools?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Middle Schools

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Middle Schools Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06292078. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.