Skill-Building Approach for Opioid Abuse

(ISLA Trial)

Recruiting at 2 trial locations

Overseen By Rhonda N Nese, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Oregon

Disqualifiers: Non-English/Spanish speakers, Alternate assessment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

5076 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new teaching method called the Instructional Skill-Building Learning Approach (ISLA) to determine its effectiveness in reducing substance misuse and improving experiences for students and teachers in middle schools. The trial involves two groups of schools: one will implement the new method, while the other will continue with their usual practices for comparison. Teachers and students in grades 6 to 8 from the selected schools can participate, especially those who interact regularly with students or are in grades 7 to 8 during the trial period. As an unphased trial, this study provides a unique opportunity to contribute to educational innovation and potentially enhance the learning environment in schools.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Instructional Skill-Building Learning Approach (ISLA) is safe for reducing substance misuse?

Research has shown that the Instructional Skill-Building Learning Approach (ISLA) safely addresses school discipline and substance misuse. ISLA keeps students engaged and connected to school rather than excluding them for misbehavior. This method uses positive classroom techniques to prevent problems before they occur.

Studies indicate that ISLA can enhance classroom experiences without safety concerns or negative effects. As a teaching method, not a medication, ISLA lacks the physical side effects drugs might have. Teachers and students involved with ISLA report positive changes in behavior and learning, with no harmful outcomes. Therefore, participating in a study involving ISLA should pose low risk for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Skill-Building Approach for Opioid Abuse because it focuses on teaching life skills in a school setting, which is a fresh angle compared to traditional treatments like medication-assisted therapy or counseling. Unlike standard treatments that often focus directly on the individual struggling with opioid use, this approach empowers school staff to implement strategies that can prevent abuse before it starts. The Instructional Skill-Building Learning Approach (ISLA) aims to equip students with practical skills and resilience, potentially reducing the risk of opioid misuse by addressing root causes and improving overall well-being. This proactive, educational method offers a promising new pathway for prevention, which could significantly shift how we tackle opioid abuse in communities.

What evidence suggests that the Instructional Skill-Building Learning Approach (ISLA) is effective for reducing substance misuse?

Research has shown that the Instructional Skill-Building Learning Approach (ISLA), which participants in this trial may experience, can reduce harsh discipline in schools and improve student success. One study found that ISLA creates a more positive school environment through teaching and restorative methods. This approach also helps prevent opioid misuse by educating students and changing their views on opioids. Students who participated in ISLA reported better school experiences and improved learning. Overall, ISLA aims to help students develop skills to make healthier choices. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for educators (administrators, teachers, instructional assistants, school counselors) in middle schools who have regular contact with students. Participants will be from 60 different schools across six states and must consent to provide data through annual surveys at three time points over two years.

Inclusion Criteria

I am an educator involved with students and will participate in all ISLA activities.

I work at a school participating in a specific study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Baseline data collection occurs before the implementation of ISLA

1 year

Treatment

Implementation of ISLA in schools, with training and support for school staff

2 years

Ongoing school visits and support

Follow-up

Participants are monitored for effectiveness of ISLA on student outcomes and substance misuse

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Instructional Skill-Building Learning Approach (ISLA)

Trial Overview The Inclusive Skill-building Learning Approach (ISLA) is being tested for its effectiveness in reducing exclusionary discipline practices in schools, improving teacher-student interactions, enhancing student outcomes, and decreasing substance misuse among students.

How Is the Trial Designed?

Group I: Wave 2 Instructional Skill-Building Learning Approach (ISLA) Experimental Treatment 1 Intervention

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.

Group II: Wave 1 Instructional Skill-Building Learning Approach (ISLA) Experimental Treatment 1 Intervention

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.

Group III: Wave 1 Waitlist Control Active Control 1 Intervention

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

Group IV: Wave 2 Waitlist Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Oregon

Lead Sponsor

Trials

91

Recruited

46,700+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A technology-assisted education program effectively taught 40 adults at high risk of opioid overdose about opioids and related medications, with significant improvements in test accuracy after each course (p < .001).

Participants completed the program in a median time of 91 minutes, and the learning outcomes were consistent across different backgrounds, indicating the program's broad applicability and potential for reducing overdose risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-assisted opioid education for out-of-treatment adults with opioid use disorder. Toegel, F., Novak, MD., Rodewald, AM., et al.[2023]

An educational intervention on opioid overdose delivered through either computer or pamphlet significantly increased participants' knowledge about opioid effects and overdose responses, with the most notable improvement in understanding how to respond to an overdose (from 41.8% to 73.8% correct responses).

The intervention not only improved knowledge but also led to a reduction in risky behaviors, such as using opioids alone, which is a critical factor in overdose risk, and this knowledge was retained at 1 and 3-month follow-ups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a computerized opioid overdose education intervention. Dunn, KE., Yepez-Laubach, C., Nuzzo, PA., et al.[2022]

A study involving 194 surgical providers across four hospitals revealed significant gaps in knowledge regarding opioid prescribing and management, with average assessment scores improving from 59% to 68% after a 75-minute educational session.

The educational intervention not only increased knowledge but also boosted providers' confidence in prescribing opioids, with 95% of participants indicating that the training would positively influence their practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing and Evaluating a Multihospital Standardized Opioid Curriculum for Surgical Providers. Robinson, KA., Carroll, M., Ward, SB., et al.[2022]

Training student pharmacists with either video or written materials significantly improved their knowledge, self-efficacy, and communication skills regarding naloxone, a medication used to reverse opioid overdoses.

While students who received video training reported higher self-efficacy initially, the type of training material did not significantly affect the overall outcomes when accounting for demographic factors, indicating that both methods are effective for enhancing naloxone communication skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the impact of brief training on student pharmacists' naloxone communication skills. Jankowski, K., Evon, DM., Stover, AN., et al.[2023]

The train-the-trainer model for overdose education and naloxone distribution significantly increased participants' knowledge and confidence in teaching others, especially among those with no prior experience, as shown by a statistically significant improvement (p < .001).

Six months after training, participants successfully trained 243 new individuals, highlighting the effectiveness of this model in expanding the reach of naloxone education to combat the opioid overdose epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the take ACTION Train-the-Trainer model of opioid overdose education with naloxone distribution- who benefits? Dahlem, CH., Scalera, M., Chen, B., et al.[2021]

A study involving 24,428 prescribers assessed the impact of extended-release/long-acting opioid training on prescribing behaviors over a 5-year period, but found no significant changes in the proportion of opioid-nontolerant patients receiving ER/LA opioids.

Although there were slight reductions in the concomitant use of central nervous system depressants like benzodiazepines and hypnotics, these changes were not clinically significant, indicating that the training did not lead to meaningful improvements in prescribing practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of the extended-release/long-acting opioid analgesics risk evaluation and mitigation strategy on prescribing practices. Secrest, MH., Phillips, S., Cepeda, MS., et al.[2023]

The IOTOD conference has effectively influenced healthcare professionals' attitudes towards managing opioid dependence, with a growing consensus on the importance of individualized treatment plans and psychosocial interventions.

Delegates' commitments to change, measured after educational sessions, indicate that the conference is successfully promoting best practices and improving clinical applications in opioid dependence treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving outcomes in the treatment of opioid dependence (IOTOD): reflections on the impact of a medical education initiative on healthcare professionals' attitudes and clinical practice. Webster, S., Robinson, S., Ali, R., et al.[2020]

A pilot study involving 152 military health system beneficiaries demonstrated that an app-based pain education program was feasible and well-received, with 73% of participants finding the videos helpful.

The study suggests that providing tablet-based pain management education in various clinic settings, not just specialty pain clinics, can enhance patient understanding and discussions about pain management and opioid safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

App-Based Pain Management and Opioid Education Program for Patients in Clinic Waiting Rooms. Highland, KB., Giordano, NA., Kirk, K., et al.[2021]

A learning activity involving an objective structured learning examination (OSLE) significantly improved third-year pharmacy students' confidence in identifying and communicating about at-risk opioid behaviors, as shown by pre- and post-survey results from 143 students.

Students reported high satisfaction with the OSLE, achieving a mean score of 34.2 out of 45, and reflected on the importance of patient-centered care and effective communication in managing opioid-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a simulation-based learning activity for communicating about at-risk opioid behaviors in a community pharmacy setting. Crowl, A., Robertson, A., Go, S., et al.[2023]

The ORION tool, an innovative e-health psychoeducational software, was developed to inform opioid-dependent individuals about overdose risks and identified seven key risk factors related to their behaviors.

While the ORION tool did not significantly change self-efficacy scores in participants, it effectively identified those at higher risk, suggesting that it could be a valuable component of a broader intervention strategy when combined with other support methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement in the Overdose RIsk InfOrmatioN (ORION) e-Health Tool for Opioid Overdose Prevention and Self-Efficacy: A Preliminary Study. Carrà, G., Crocamo, C., Humphris, G., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11138586

Preventing School Exclusion and Opioid Misuse The proposed project aims to evaluate the effectiveness of ISLA, an instructional and restorative alternative to exclusionary discipline, on improving the ...

2. allclinicaltrials.com allclinicaltrials.com/study/NCT06292078

Preventing School Exclusion and Opioid Misuse This project will test the effectiveness of the Inclusive Skill-building Learning Approach (ISLA) in reducing the use of exclusionary discipline, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0306460325000231

Effectiveness of educational interventions in United States ... This review evaluates the effectiveness of school-based opioid education programs in preventing opioid-related harms, and improving knowledge, attitudes, and ...

4. mdpi.com mdpi.com/2673-7051/5/2/19

Student Experiences with the Instructional Skill-Building ... This study examined eighth-grade students' experiences in their middle school environments during implementation of the inclusive skill-building learning ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/00220574241309893

A Quasi-Experimental Study of the Inclusive Skill-Building ... This study examined the impact of a classroom-level component of The Inclusive Skill-building Learning Approach (ISLA), an instructional and restorative ...

6. pbis.org pbis.org/resource/instructional-and-restorative-alternatives-to-exclusionary-discipline-isla-guide

Instructional and Restorative Alternatives to Exclusionary ... In this brief, we outline the five components of the ISLA model, as well as steps that school and district teams can take to begin implementing these practices.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK458653/

Evidence on Strategies for Addressing the Opioid Epidemic The purpose of this chapter is to review available evidence on strategies that have been used to address the problems of opioid misuse, OUD, and related deaths.

8. ies.ed.gov ies.ed.gov/use-work/awards/development-instructional-alternative-out-school-suspension-instructional-suspension-learning

The Instructional Suspension Learning Alternative (ISLA) | IES ISLA is a school-wide alternative to exclusionary discipline that begins with universal prevention grounded in positive proactive classroom strategies for all ...

9. scholarsbank.uoregon.edu scholarsbank.uoregon.edu/bitstreams/71f64066-8c9a-47dd-a092-167d13d90b70/download

The Inclusive Skill-Building Learning Approach (ISLA) an ... This study explores the impact of the Inclusive Skill-Building Learning Approach. (ISLA), an instructional and restorative alternative to exclusionary ...