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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Instructional Skill-Building Learning Approach (ISLA) for opioid abuse?

The IOTOD conference, an educational initiative, has shown that healthcare professionals are increasingly positive about incorporating individualized treatment plans and psychosocial interventions for opioid dependence, suggesting that educational approaches like ISLA may be effective in changing attitudes and practices in opioid abuse treatment. ^{1 2 3 4 5}

How is the ISLA treatment different from other treatments for opioid abuse?

The ISLA treatment is unique because it focuses on building skills through an instructional approach, which may involve learning and practicing new behaviors to manage opioid abuse, rather than just providing medication or education about overdose prevention. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of the extended-release/long-acting opioid analgesics risk evaluation and mitigation strategy on prescribing practices. [2023]

2. United States 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. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Technology-assisted opioid education for out-of-treatment adults with opioid use disorder. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Implementing and Evaluating a Multihospital Standardized Opioid Curriculum for Surgical Providers. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

App-Based Pain Management and Opioid Education Program for Patients in Clinic Waiting Rooms. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of the take ACTION Train-the-Trainer model of opioid overdose education with naloxone distribution- who benefits? [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a computerized opioid overdose education intervention. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a simulation-based learning activity for communicating about at-risk opioid behaviors in a community pharmacy setting. [2023]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Exploring the impact of brief training on student pharmacists' naloxone communication skills. [2023]

10. United States 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. [2022]