Clinical trial NCT05209191: 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
Overall status: COMPLETED
Phase: NA
Conditions: Prescription Opioid Misuse
Lead sponsor: Real Prevention, LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Missouri-Columbia
First posted: 2022-01-26
Enrollment: 102
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participating athletes assigned to treatment condition.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Usability
timeFrame: Posttest
measure: Engagement
timeFrame: Posttest
measure: Efficacy in Resisting Offers of Opioids
timeFrame: Posttest.
measure: Number of Participants Willing to Misuse Prescription Opioids
timeFrame: Posttest
Secondary outcomes:
Other outcomes:
Locations:
city: Clifton
country: United States
facility: Clifton High School
state: New Jersey
city: York
country: United States
facility: Central York High School
state: Pennsylvania
city: York
country: United States
facility: Northern York High School
state: Pennsylvania
city: York
country: United States
facility: York Catholic High School
state: Pennsylvania
city: Galveston
country: United States
facility: Dickinson High School
state: Texas
Study officials:
affiliation: Real Prevention, LLC
name: Michael L Hecht
role: PRINCIPAL_INVESTIGATOR
References:
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.