NCT06292078 Preventing School Exclusion and Opioid Misuse: Effectiveness of the Inclusive Skill-building Learning Approach (ISLA)
| NCT ID | NCT06292078 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oregon |
| Condition | Middle Schools |
| Study Type | INTERVENTIONAL |
| Enrollment | 5,076 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 5,076 participants in total. It began in 2024-04-15 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06292078 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 15 Years, studying Middle Schools. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06292078 currently recruiting?
Yes, NCT06292078 is actively recruiting participants. Contact the research team at seana@uoregon.edu for enrollment information.
Where is the NCT06292078 trial being conducted?
This trial is being conducted at Capitola, United States, Yuba City, United States, Salem, United States.
Who is sponsoring the NCT06292078 clinical trial?
NCT06292078 is sponsored by University of Oregon. The trial plans to enroll 5,076 participants.