Recruiting

ISLA

Sponsor:

University of Oregon

Code:

NCT06292078

Conditions

Middle Schools

School Exclusion

School Community

Teaching Practices

Opioid and Other Substance Misuse

Eligibility Criteria

Sex: All

Age: 8 - 15

Healthy Volunteers: Accepted

Interventions

Instructional Skill-Building Learning Approach (ISLA)

Study Details

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.

Conditions

Middle Schools

School Exclusion

School Community

Teaching Practices

Opioid and Other Substance Misuse

Study ID

NCT06292078

Start date

Apr 15, 2024

Status verified date

Jul, 2025

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 15

Healthy Volunteers: Accepted

Teachers: The educator sample will include all educators within each of the schools. All educators that have regular contact with students (e.g., administrators, teachers, instructional assistants, school counselors) will participate in the school-wide ISLA intervention activities. All educators at both treatment and control schools, if they consent, will provide data through an annual survey administered at three time points: in the spring prior to the first year of ISLA implementation (baseline), in the spring of the first year of ISLA implementation (post-intervention), and in the spring of the second year of ISLA implementation (follow-up).

  • 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.

  • Inclusion Criteria:

\* 6th grade students in either intervention or control schools during first data collection period for each wave
  • Exclusion Criteria:

  • 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.

Study Design

Enrollment

5076 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Wave 1 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.

no intervention: Wave 1 Waitlist Control

These 15 schools will receive no intervention while wave 1 intervention schools undergo training and coaching on ISLA.

experimental: Wave 2 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.

no intervention: Wave 2 Waitlist Control

These 15 schools will receive no intervention while wave 2 intervention schools undergo training and coaching on ISLA.

Interventions

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 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 ]
  • Engagement vs. Disaffection with Learning Student-report [ Time Frame: baseline, 1 year, 2 years ]
  • Inclusive Teaching Practices [ Time Frame: baseline, 1 year, 2 years ]
  • School Climate Survey- Student [ Time Frame: baseline, 1 year, 2 years ]
  • School Climate- Teacher [ Time Frame: baseline, 1 year, 2 years ]
  • Student-Teacher Relationships [ Time Frame: baseline, 1 year, 2 years ]
  • Opioid and Other Substance Misuse [ Time Frame: baseline, 1 year, 2 years ]
  • Student Internalizing Behaviors [ Time Frame: baseline, 1 year, 2 years ]
  • Student Externalizing Behaviors [ Time Frame: baseline, 1 year, 2 years ]
  • ISLA Acceptability [ Time Frame: 1 year and 2 years for intervention condition schools ]
  • ISLA Implementation Fidelity [ Time Frame: baseline, 1 year, 2 years ]

Central Contacts and Locations

Central contacts

Locations

Soquel Union Elementary School District

Recruiting

Capitola, California, United States, 95010

Contacts

Carissa Lemos

clemos@suesd.org

Riverbend School District

Recruiting

Yuba City, California, United States, 95991

Contacts

Salem-Keizer School District

Recruiting

Salem, Oregon, United States, 97301

Contacts

Julia Dewitt

971-599-7825

More Information

Sponsor

University of Oregon

Last update posted

May 22, 2026

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oregon on 2026-05-22.