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

Prescription Opioid Misuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05209191
• Other study ID #: R44DA051243-01
• Status: Completed
• Phase: N/A
• Start date: April 24, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2023
• Source: Real Prevention, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 30, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Prescription Opioid Misuse

Intervention

Behavioral:
• Student Athlete Wellness Portal
A web-based design that illustrates various opioid misuse and diversion resistance strategies.

Locations

Country	Name	City	State
United States	Clifton High School	Clifton	New Jersey
United States	Dickinson High School	Galveston	Texas
United States	Central York High School	York	Pennsylvania
United States	Northern York High School	York	Pennsylvania
United States	York Catholic High School	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Real Prevention, LLC	University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

References & Publications (1)

Jayawardene W, Pezalla A, Henderson C, Hecht M. Development of opioid rapid response system: Protocol for a randomized controlled trial. Contemp Clin Trials. 2022 Apr;115:106727. doi: 10.1016/j.cct.2022.106727. Epub 2022 Mar 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Posttest
Primary	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.	Posttest
Primary	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.	Posttest.
Primary	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.	Posttest