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| Name | Class |
|---|---|
| University of Missouri-Columbia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Student Athlete Wellness Portal | Experimental | Web-based intervention that illustrates opioid misuse and diversion resistance strategies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Student Athlete Wellness Portal | Behavioral | A web-based design that illustrates various opioid misuse and diversion resistance strategies. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael L Hecht | Real Prevention, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clifton High School | Clifton | New Jersey | 07013 | United States | ||
| Central York High School |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35296414 | Background | 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. |
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Data will be shared according to NIH procedures once publications are completed.
Once papers reporting results are published.
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).
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 13, 2022 |
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Participating athletes assigned to treatment condition.
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Participants will know if they are receiving the Student Athlete Wellness Portal intervention during the study or afterwards.
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| York |
| Pennsylvania |
| 17401 |
| United States |
| Northern York High School | York | Pennsylvania | 17401 | United States |
| York Catholic High School | York | Pennsylvania | 17403 | United States |
| Dickinson High School | Galveston | Texas | 77539 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Measured on checklist | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Posttest |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Posttest |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | Posttest. |
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| 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. | Posted | Count of Participants | Participants | Posttest |
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Participants were involved in study for approximately 30 minutes or less.
Anticipated Adverse Events: discomfort with topic, violation of confidentiality Anticipated Serious Adverse Events: none anticipated
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 102 | 0 | 102 | 0 | 102 |
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COVID caused a change to a single group study, eliminating the control group. The brevity of the study resulted in fewer items & lower reliability than desirable in some cases.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael L. Hecht | REAL Prevention LLC | 18143601893 | HECHTPSU@GMAIL.COM |
| Apr 28, 2023 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Black or African American |
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| Asian |
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| American Indian/Alaskan Native |
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| other |
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