Prescription Opioid Misuse
Conditions
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.
Interventions
BEHAVIORALStudent Athlete Wellness Portal
A web-based design that illustrates various opioid misuse and diversion resistance strategies.
Sponsors
University of Missouri-Columbia
Real Prevention, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Masking description
Participants will know if they are receiving the Student Athlete Wellness Portal intervention during the study or afterwards.
Intervention model description
Participating athletes assigned to treatment condition.
Eligibility
Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability | Posttest | 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 | Posttest | 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 | Posttest. | 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 | Posttest | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment for the trial began April 24, 2020. Four high schools were recruited to participate. Due to COVID-19, 3 dropped out. New high schools were recruited to replace them but new waves of COVID required delays in completing recruitment.
Participants by arm
| Arm | Count |
|---|---|
| Student Athlete Wellness Portal Web-based intervention that illustrates opioid misuse and diversion resistance strategies.
Student Athlete Wellness Portal: A web-based design that illustrates various opioid misuse and diversion resistance strategies. | 102 |
| Total | 102 |
Baseline characteristics
| Characteristic | Student Athlete Wellness Portal |
|---|---|
| Age, Continuous | 16.6 years STANDARD_DEVIATION 1.5 |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 5 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants |
| Race/Ethnicity, Customized Black or African American | 17 Participants |
| Race/Ethnicity, Customized Hispanic | 8 Participants |
| Race/Ethnicity, Customized other | 10 Participants |
| Race/Ethnicity, Customized White, not Hispanic | 57 Participants |
| Region of Enrollment United States | 102 Participants |
| Sex: Female, Male Female | 49 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 102 |
| other Total, other adverse events | 0 / 102 |
| serious Total, serious adverse events | 0 / 102 |
Outcome results
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.
Time frame: Posttest.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Student Athlete Wellness Portal | Efficacy in Resisting Offers of Opioids | 3.91 score on a scale | Standard Deviation 1.02 |
Comparison: Paired t-test.p-value: 0.38t-test, 2 sided
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.
Time frame: Posttest
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Student Athlete Wellness Portal | Engagement | 3.50 score on a scale | Standard Deviation 0.72 |
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.
Time frame: Posttest
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Student Athlete Wellness Portal | Number of Participants Willing to Misuse Prescription Opioids | Pretest | 44 Participants |
| Student Athlete Wellness Portal | Number of Participants Willing to Misuse Prescription Opioids | Posttest | 37 Participants |
p-value: 0.001Chi-squared
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.
Time frame: Posttest
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Student Athlete Wellness Portal | Usability | 3.49 score on a scale | Standard Deviation 0.65 |
p-value: 0.001t-test, 2 sided