Clinical trial NCT04253158: Implementation of a Web-based Alcohol and Other Drug Prevention Intervention for Collegiate Student-athletes
Official title: Drug and Alcohol Prevention for College Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Social Norms
Expectations
Harm Reduction
Lead sponsor: Prevention Strategies, LLC
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 3859
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The broad aim of the proposed study is to use the innovative Multiphase Optimization Strategy to develop a highly effective Internet-delivered intervention, myPlaybook, for the prevention of substance use among college student-athletes. myPlaybook will undergo two rounds of randomized experimentation and targeted revision. At the conclusion of the second round, the optimized version of myPlaybook will be evaluated in large-scale Randomized Controlled Trial (RCT).

Detailed description: College student-athletes are at increased risk of heavy alcohol use, smokeless tobacco use, and the use of performance enhancing substances as compared to non-athlete college students. Despite recent research underscoring the need for athlete-tailored interventions, there are no evidence-based options for the prevention of substance use among college student-athletes that take into account their unique patterns and motivations for use. This void leaves colleges with few easy-to-use, effective, and economical options for meeting the needs of their student-athletes and the minimum drug education requirements set by their governing organizations. The broad aim of the proposed study is to use the innovative Multiphase Optimization Strategy to develop a highly effective Internet-delivered program (myPlaybook) for the prevention of substance use among college student-athletes. The MOST approach is a systematic method for making decisions about program development and adaptation that are based on the performance of individual program components. The five core lessons of myPlaybook will undergo two rounds of randomized experimentation and targeted revision. At the conclusion of the second round, the newly optimized version of myPlaybook will be assembled and evaluated in large-scale Randomized Controlled Trial (RCT). This "beta" version of myPlaybook will be compared to an Internet-based college alcohol intervention with proven effectiveness with general college students. This approach will allow us to 1) develop an intervention that is optimized for considerable impact on substance use outcomes and 2) demonstrate the need for interventions specifically adapted for college student-athletes. The proposed research will be among the first demonstrations of the MOST approach for building and evaluating behavioral interventions with greatly enhanced public health impact. PUBLIC HEALTH RELEVANCE: This project has the potential to contribute to the health and safety of the more than 460,000 college student-athletes in the US. A contribution to the science of prevention will be made by demonstrating an innovative approach for the development and revision of behavioral interventions that focuses on achieving both statistical significance and optimizing public health impact.

Eligibility criteria: Inclusion Criteria:

* equal to or greater than 18 years of age
* registered first year student-athlete
* competes on NCAA sponsored team
* full-time NCAA collegiate student-athlete

Exclusion

* equal to or less than 17 years of age
* greater than 25 years of age
* non-NCAA sponsored athlete

Primary outcomes:
measure: Descriptive norms: DRINKING NORMS RATING FORM (adapted DNRF)
timeFrame: past 30-day
measure: Injunctive norms:DRINKING NORMS RATING FORM (adapted DNRF)
timeFrame: past 30-day
measure: Negative expectancies: COMPREHENSIVE EFFECTS OF ALCOHOL Scale (adapted CEOA)
timeFrame: past 30-day
measure: Positive expectancies: COMPREHENSIVE EFFECTS OF ALCOHOL Scale (adapted CEOA)
timeFrame: past 30-day
Secondary outcomes:
measure: PROTECTIVE BEHAVIORAL STRATEGIES SCALE-20 (adapted - PBSS-20)
timeFrame: past 30-day
Other outcomes:
Locations:
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