An interventional study of Student Athlete Wellness Portal in Prescription Opioid Misuse, sponsored by Real Prevention, LLC. Completed at 5 sites in United States. Open to participants aged 13 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by Real Prevention, LLC · Not applicable, Interventional, and Prevention
The goal of this study is to prevent prescription opioid misuse among high school athletes by developing, demonstrating the feasibility, and evaluating the outcomes of an innovative digital intervention.
The goal of this proposal is to prevent prescription opioid misuse among high school athletes by developing, demonstrating the feasibility, and evaluating the outcomes of an innovative digital intervention. The new program, the Student Athlete Wellness Portal (SAWP), will be a brief, web- and smartphone-based curriculum, and will encourage resistance to cultural influences to misuse prescription opioids. This portal, which was created based on formative interviews with athletes, coaches, athletic trainers, and school administrators, will be tested in a feasibility trial. One hundred and two high school athletes completed a pretest, participated in the treatment (the SAWP) and completed posttest assess their knowledge, perceptions, and behaviors relating to opioid medication.
1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's enrollment of 102 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →Real Prevention, LLC is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Web-based intervention that illustrates opioid misuse and diversion resistance strategies.
Behavioral: Student Athlete Wellness Portal
A web-based design that illustrates various opioid misuse and diversion resistance strategies.
Usability
10 items in agree-disagree format (sale 1-5) modified from the SUS scale to measure the useability of a website. Range 1-5, higher scores reflect better usability.
Time frame: Posttest
Engagement
8 items in agree-disagree (scale 1-5) format to measure the degree to which a participant felt engaged with the website. Range 1-5, with higher scores reflecting more engagement. Subscales of interest, realism, and identification.
Time frame: Posttest
Efficacy in Resisting Offers of Opioids
2 items measuring the degree (scale 1-5) to which participants felt confident resisting offers of prescription opioids. Range 1-5, with higher scores reflecting more efficacy.
Time frame: Posttest.
Number of Participants Willing to Misuse Prescription Opioids
2 items measured participants' willing to misuse opioids. Each presented a scenario followed by a checklist, each with 6 options indicating possible responses to opioid offers. For analyses, items were dichotomized to indicate if participants were willing to misuse (1) or not willing (0). If they checked any of the choices indicating they were willing to misuse prescription opioids, they were scored 1, which is the worst outcome. Range 0-1.
Time frame: Posttest
Recruitment for the trial began April 24, 2020. Four high schools were recruited to participate. Due to COVID-19, 3 dropped out. New high schools were recruited to replace them but new waves of COVID required delays in completing recruitment.
| Milestone | Student Athlete Wellness Portal |
|---|---|
| Started | 102 |
| Completed | 102 |
| Not completed | 0 |
10 items in agree-disagree format (sale 1-5) modified from the SUS scale to measure the useability of a website. Range 1-5, higher scores reflect better usability.
| score on a scale | Student Athlete Wellness Portal |
|---|---|
| Usability | 3.49 ± 0.65 |
8 items in agree-disagree (scale 1-5) format to measure the degree to which a participant felt engaged with the website. Range 1-5, with higher scores reflecting more engagement. Subscales of interest, realism, and identification.
| score on a scale | Student Athlete Wellness Portal |
|---|---|
| Engagement | 3.50 ± 0.72 |
2 items measuring the degree (scale 1-5) to which participants felt confident resisting offers of prescription opioids. Range 1-5, with higher scores reflecting more efficacy.
| score on a scale | Student Athlete Wellness Portal |
|---|---|
| Efficacy in Resisting Offers of Opioids | 3.91 ± 1.02 |
2 items measured participants' willing to misuse opioids. Each presented a scenario followed by a checklist, each with 6 options indicating possible responses to opioid offers. For analyses, items were dichotomized to indicate if participants were willing to misuse (1) or not willing (0). If they checked any of the choices indicating they were willing to misuse prescription opioids, they were scored 1, which is the worst outcome. Range 0-1.
| Participants | Student Athlete Wellness Portal |
|---|---|
| Pretest | 44 |
| Posttest | 37 |
Collected over Participants were involved in study for approximately 30 minutes or less.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Student Athlete Wellness Portal | 0/102 (0%) | 0/102 (0%) | 0/102 (0%) |
| Age, Continuous(years) | Student Athlete Wellness Portal |
|---|---|
| Mean | 16.6 ± 1.50 |
| Sex: Female, Male(Participants) | Student Athlete Wellness Portal |
|---|---|
| Female | 49 |
| Male | 53 |
| Race/Ethnicity, Customized(Participants) | Student Athlete Wellness Portal |
|---|---|
| Hispanic | 8 |
| White, not Hispanic | 57 |
| Black or African American | 17 |
| Asian | 5 |
| American Indian/Alaskan Native | 5 |
| other | 10 |
| Region of Enrollment(Participants) | Student Athlete Wellness Portal |
|---|---|
| United States | 102 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data will be shared according to NIH procedures once publications are completed.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Real Prevention, LLC