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OpenTrials
Completed

NCT Number: NCT05209191

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

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.

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Key information

Conditions

Prescription Opioid Misuse Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clifton High School, Clifton, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Student Athlete Wellness Portal

Behavioral

A web-based design that illustrates various opioid misuse and diversion resistance strategies.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Real Prevention, LLC

Industry

Collaborators

  • University of Missouri-Columbia

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 26, 2022
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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