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

NCT ID: NCT05209191

Last Updated: 2023-09-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-24

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Prescription Opioid Misuse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participating athletes assigned to treatment condition.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Participants will know if they are receiving the Student Athlete Wellness Portal intervention during the study or afterwards.

Study Groups

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Student Athlete Wellness Portal

Web-based intervention that illustrates opioid misuse and diversion resistance strategies.

Group Type EXPERIMENTAL

Student Athlete Wellness Portal

Intervention Type BEHAVIORAL

A web-based design that illustrates various opioid misuse and diversion resistance strategies.

Interventions

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Student Athlete Wellness Portal

A web-based design that illustrates various opioid misuse and diversion resistance strategies.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role collaborator

Real Prevention, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Michael Hecht

President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael L Hecht

Role: PRINCIPAL_INVESTIGATOR

Real Prevention, LLC

Locations

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Clifton High School

Clifton, New Jersey, United States

Site Status

Central York High School

York, Pennsylvania, United States

Site Status

Northern York High School

York, Pennsylvania, United States

Site Status

York Catholic High School

York, Pennsylvania, United States

Site Status

Dickinson High School

Galveston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 35296414 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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R44DA051243-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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