Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05209191
Other study ID # R44DA051243-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06387290 - Optimizing Chronic Pain Care With Mindfulness and Chronic Pain Management Visits N/A
Completed NCT02791399 - A Patient-Centered Intervention to Improve Opioid Safety N/A
Completed NCT05358522 - Increasing Implementation of Post-Operative Opioid Prescribing Guidelines N/A
Completed NCT05362357 - iSTART: A Campus & Community Initiative for Services in Tec-health N/A