Reducing High School Athletes' Prescription Opioids Misuse and Diversion Through the Student Athlete Wellness Portal
Primary Purpose
Prescription Opioid Misuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Student Athlete Wellness Portal
Sponsored by
About this trial
This is an interventional prevention trial for Prescription Opioid Misuse
Eligibility Criteria
Inclusion Criteria:
- English-speaking male and female adolescents
- Agesd 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
Sites / Locations
- Clifton High School
- Central York High School
- Northern York High School
- York Catholic High School
- Dickinson High School
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Student Athlete Wellness Portal
Arm Description
Web-based intervention that illustrates opioid misuse and diversion resistance strategies.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05209191
First Posted
January 12, 2022
Last Updated
August 21, 2023
Sponsor
Real Prevention, LLC
Collaborators
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT05209191
Brief Title
Reducing High School Athletes' Prescription Opioids Misuse and Diversion Through the Student Athlete Wellness Portal
Official Title
Reducing High School Athletes' Prescription Opioids Misuse and Diversion Through the Student Athlete Wellness Portal
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 24, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Real Prevention, LLC
Collaborators
University of Missouri-Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prescription Opioid Misuse
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Participating athletes assigned to treatment condition.
Masking
None (Open Label)
Masking Description
Participants will know if they are receiving the Student Athlete Wellness Portal intervention during the study or afterwards.
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Student Athlete Wellness Portal
Arm Type
Experimental
Arm Description
Web-based intervention that illustrates opioid misuse and diversion resistance strategies.
Intervention Type
Behavioral
Intervention Name(s)
Student Athlete Wellness Portal
Intervention Description
A web-based design that illustrates various opioid misuse and diversion resistance strategies.
Primary Outcome Measure Information:
Title
Usability
Description
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.
Time Frame
Posttest
Title
Engagement
Description
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.
Time Frame
Posttest
Title
Efficacy in Resisting Offers of Opioids
Description
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.
Time Frame
Posttest.
Title
Number of Participants Willing to Misuse Prescription Opioids
Description
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.
Time Frame
Posttest
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L Hecht
Organizational Affiliation
Real Prevention, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clifton High School
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07013
Country
United States
Facility Name
Central York High School
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17401
Country
United States
Facility Name
Northern York High School
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17401
Country
United States
Facility Name
York Catholic High School
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Dickinson High School
City
Galveston
State/Province
Texas
ZIP/Postal Code
77539
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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).
Citations:
PubMed Identifier
35296414
Citation
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.
Results Reference
background
Learn more about this trial
Reducing High School Athletes' Prescription Opioids Misuse and Diversion Through the Student Athlete Wellness Portal
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