Clinical trial NCT06292078: Preventing School Exclusion and Opioid Misuse: Effectiveness of the Inclusive Skill-building Learning Approach (ISLA)
Official title: Preventing School Exclusion and Opioid Misuse: Effectiveness of the Inclusive Skill-building Learning Approach (ISLA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Misuse
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-03-04
Enrollment: 5076
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency and Duration of Use of Office Discipline Referrals, In-School Suspension, and Out-of-School Suspension
timeFrame: baseline, 1 year, 2 years
measure: Engagement vs. Disaffection with Learning Student-report
timeFrame: baseline, 1 year, 2 years
measure: Inclusive Teaching Practices
timeFrame: baseline, 1 year, 2 years
measure: School Climate Survey- Student
timeFrame: baseline, 1 year, 2 years
measure: School Climate- Teacher
timeFrame: baseline, 1 year, 2 years
measure: Student-Teacher Relationships
timeFrame: baseline, 1 year, 2 years
measure: Opioid and Other Substance Misuse
timeFrame: baseline, 1 year, 2 years
measure: Student Internalizing Behaviors
timeFrame: baseline, 1 year, 2 years
measure: Student Externalizing Behaviors
timeFrame: baseline, 1 year, 2 years
measure: ISLA Acceptability
timeFrame: 1 year and 2 years for intervention condition schools
measure: ISLA Implementation Fidelity
timeFrame: baseline, 1 year, 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Capitola
country: United States
facility: Soquel Union Elementary School District
state: California
city: Yuba City
country: United States
facility: Riverbend School District
state: California
city: Salem
country: United States
facility: Salem-Keizer School District
state: Oregon
Study officials:
References: