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

August 21, 2023 updated by: Michael Hecht, Real Prevention, LLC
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Clifton, New Jersey, United States, 07013
        • Clifton High School
    • Pennsylvania
      • York, Pennsylvania, United States, 17401
        • Central York High School
      • York, Pennsylvania, United States, 17401
        • Northern York High School
      • York, Pennsylvania, United States, 17403
        • York Catholic High School
    • Texas
      • Galveston, Texas, United States, 77539
        • Dickinson High School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Student Athlete Wellness Portal
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Posttest
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.
Posttest
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.
Posttest.
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.
Posttest

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Real Prevention, LLC

Collaborators

University of Missouri-Columbia

Investigators

  • Principal Investigator: Michael L Hecht, Real Prevention, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2020

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

January 12, 2022

First Submitted That Met QC Criteria

January 25, 2022

First Posted (Actual)

January 26, 2022

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R44DA051243-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared according to NIH procedures once publications are completed.

IPD Sharing Time Frame

Once papers reporting results are published.

IPD Sharing Access Criteria

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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