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Clinical Trials/NCT05209191
NCT05209191
Completed
N/A

Reducing High School Athletes' Prescription Opioids Misuse and Diversion Through the Student Athlete Wellness Portal

Real Prevention, LLC5 sites in 1 country102 target enrollmentApril 24, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Prescription Opioid Misuse
Sponsor
Real Prevention, LLC
Enrollment
102
Locations
5
Primary Endpoint
Efficacy in Resisting Offers of Opioids
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 24, 2020
End Date
June 30, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Hecht

President

Real Prevention, LLC

Eligibility Criteria

Inclusion Criteria

  • English-speaking male and female adolescents
  • Ages 13-19
  • Attending middle or high school
  • Playing at last one interscholastic sport
  • Parental consent

Exclusion Criteria

  • No parental consent
  • outside the age range
  • not participating in interscholastic sports
  • not in middle or high school
  • participated in the Phase I research

Outcomes

Primary Outcomes

Efficacy in Resisting Offers of Opioids

Time Frame: Posttest.

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.

Usability

Time Frame: Posttest

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.

Engagement

Time Frame: Posttest

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.

Number of Participants Willing to Misuse Prescription Opioids

Time Frame: Posttest

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.

Study Sites (5)

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