NCT06292078

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,076

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Apr 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Apr 2024Oct 2027

First Submitted

Initial submission to the registry

February 15, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

3.5 years

First QC Date

February 15, 2024

Last Update Submit

July 16, 2025

Conditions

Outcome Measures

Primary Outcomes (11)

  • 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).

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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).

    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).

    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.

    baseline, 1 year, 2 years

Study Arms (4)

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.

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.

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.

Interventions

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.

Wave 1 Instructional Skill-Building Learning Approach (ISLA)Wave 2 Instructional Skill-Building Learning Approach (ISLA)

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Soquel Union Elementary School District

Capitola, California, 95010, United States

RECRUITING

Riverbend School District

Yuba City, California, 95991, United States

RECRUITING

Salem-Keizer School District

Salem, Oregon, 97301, United States

RECRUITING

Central Study Contacts

Sean C Austin, PhD

CONTACT

Rhonda N Nese, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2024

First Posted

March 4, 2024

Study Start

April 15, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

July 20, 2025

Record last verified: 2025-07

Locations