Reducing High School Athletes' Prescription Opioids Misuse and Diversion Through the Student Athlete Wellness Portal
1 other identifier
interventional
102
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2020
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 24, 2020
CompletedFirst Submitted
Initial submission to the registry
January 12, 2022
CompletedFirst Posted
Study publicly available on registry
January 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedResults Posted
Study results publicly available
August 22, 2023
CompletedSeptember 15, 2023
August 1, 2023
2.1 years
January 12, 2022
July 25, 2022
August 21, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
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
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
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.
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
Study Arms (1)
Student Athlete Wellness Portal
EXPERIMENTALWeb-based intervention that illustrates opioid misuse and diversion resistance strategies.
Interventions
A web-based design that illustrates various opioid misuse and diversion resistance strategies.
Eligibility Criteria
You may qualify if:
- English-speaking male and female adolescents
- Ages 13-19
- Attending middle or high school
- Playing at last one interscholastic sport
- Parental consent
You may not qualify if:
- No parental consent
- outside the age range
- not participating in interscholastic sports
- not in middle or high school
- participated in the Phase I research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Real Prevention, LLClead
- University of Missouri-Columbiacollaborator
Study Sites (5)
Clifton High School
Clifton, New Jersey, 07013, United States
Central York High School
York, Pennsylvania, 17401, United States
Northern York High School
York, Pennsylvania, 17401, United States
York Catholic High School
York, Pennsylvania, 17403, United States
Dickinson High School
Galveston, Texas, 77539, United States
Related 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.
PMID: 35296414BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
COVID caused a change to a single group study, eliminating the control group. The brevity of the study resulted in fewer items \& lower reliability than desirable in some cases.
Results Point of Contact
- Title
- Dr. Michael L. Hecht
- Organization
- REAL Prevention LLC
Study Officials
- PRINCIPAL INVESTIGATOR
Michael L Hecht
Real Prevention, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Participants will know if they are receiving the Student Athlete Wellness Portal intervention during the study or afterwards.
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- President
Study Record Dates
First Submitted
January 12, 2022
First Posted
January 26, 2022
Study Start
April 24, 2020
Primary Completion
May 31, 2022
Study Completion
June 30, 2022
Last Updated
September 15, 2023
Results First Posted
August 22, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Once papers reporting results are published.
- 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).
Data will be shared according to NIH procedures once publications are completed.