- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04253158
Implementation of a Web-based Alcohol and Other Drug Prevention Intervention for Collegiate Student-athletes
February 3, 2020 updated by: Prevention Strategies, LLC
Drug and Alcohol Prevention for College Athletes
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Behavioral: Educational standard
- Behavioral: Educational standard and Harm prevention
- Behavioral: Educational standard and Expectancies
- Behavioral: Expectancies and Harm prevention
- Behavioral: Educational standard and Normative perceptions
- Behavioral: Normative perceptions and Harm prevention
- Behavioral: Educational standard, Normative Perceptions, and Expectancies
- Behavioral: Normative perceptions, Expectancies, and Harm Prevention
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.
Study Type
Interventional
Enrollment (Actual)
3859
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Educational standard
The aim of this arm is to increase knowledge about alcohol and other drug use.
|
Behavioral intervention aimed at increasing knowledge about alcohol and other drugs.
|
Experimental: Educational standard and Harm prevention
The aim of this arm is to increase knowledge about alcohol and other drug use and increase intentions for the use of harm prevention strategies.
|
Behavioral intervention aimed at increasing knowledge about alcohol and other drugs increasing intentions to use harm prevention strategies.
|
Experimental: Educational standard and Expectancies
The aim of this arm is to increase knowledge about alcohol and other drug use and shift alcohol-related expectancies.
|
Behavioral intervention aimed at increasing knowledge about alcohol and other drugs and shifting alcohol-related expectancies.
|
Experimental: Expectancies and Harm prevention
The aim of this arm is shift alcohol-related expectancies and increase intentions to use harm prevention strategies.
|
Behavioral intervention aimed at correcting erroneous norms about alcohol use and shifting alcohol-related expectancies.
|
Experimental: Educational standard and Normative perceptions
The aim of this arm is to increase knowledge about alcohol and other drug use and correct erroneous alcohol-related normative perceptions.
|
Behavioral intervention aimed at increasing knowledge about alcohol and other drugs and correcting erroneous norms about alcohol use.
|
Experimental: Normative perceptions and Harm prevention
The aim of this arm is to correct erroneous alcohol-related normative perceptions and increase intentions to use harm prevention strategies.
|
Behavioral intervention aimed at correcting erroneous norms about alcohol use and increasing intentions to harm prevention strategies.
|
Experimental: Educational standard, Normative Perceptions, and Expectancies
The aim of this arm is to increase knowledge about alcohol and other drug use, correct erroneous alcohol-related normative perceptions, and shift alcohol-related expectancies.
|
Behavioral intervention aimed at increasing knowledge about alcohol and other drugs, correcting erroneous norms about alcohol use, and shifting alcohol-related expectancies.
|
Experimental: Normative perceptions, Expectancies, and Harm Prevention
The aim of this arm is to correct erroneous alcohol-related normative perceptions, shift alcohol-related expectancies, and increase intentions to use harm prevention strategies.
|
Behavioral intervention aimed at correcting erroneous norms about alcohol use, shifting alcohol-related expectancies, and increasing intentions to use harm prevention strategies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Descriptive norms: DRINKING NORMS RATING FORM (adapted DNRF)
Time Frame: past 30-day
|
This scale (0-100%) measured the perceptions about the frequency of others' alcohol use.
Perceived weekly drinking was computed by summing the reported estimates of drinking for each day of the week for the typical student.
The lower the score the better.
|
past 30-day
|
Injunctive norms:DRINKING NORMS RATING FORM (adapted DNRF)
Time Frame: past 30-day
|
This scale (0-100%) measured the perceptions about the frequency of others' approval of alcohol use.
Perceived approval of alcohol use of others was computed by summing the reported estimates of approval compared to the actual approval as reported by the typical student.
A lower score on this scale results in more positive effects.
|
past 30-day
|
Negative expectancies: COMPREHENSIVE EFFECTS OF ALCOHOL Scale (adapted CEOA)
Time Frame: past 30-day
|
This agreement scale (1-4) measured negative expectancies (e.g., consequences of risks and/or aggression) of alcohol related effects.
Sub-scale scores are calculated as the sum of respective items.
A lower score on this scale results in more positive effects.
|
past 30-day
|
Positive expectancies: COMPREHENSIVE EFFECTS OF ALCOHOL Scale (adapted CEOA)
Time Frame: past 30-day
|
This agreement scale (1-4) measured positive expectancies (e.g., socialability) of alcohol related effects.
Sub-scale scores are calculated as the sum of respective items.
A higher score on this scale results in more positive effects.
|
past 30-day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PROTECTIVE BEHAVIORAL STRATEGIES SCALE-20 (adapted - PBSS-20)
Time Frame: past 30-day
|
Intentions to use protective behavioral strategies (e.g., alternating alcoholic and non-alcoholic drinks).
This intentions scale (1-7) measured future intent to use alcohol-related harm prevention strategies (e.g., alternating alcoholic and non-alcoholic drinks).
A higher score on this scale results in more positive effects.
|
past 30-day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2011
Primary Completion (Actual)
May 31, 2016
Study Completion (Actual)
May 31, 2016
Study Registration Dates
First Submitted
January 27, 2020
First Submitted That Met QC Criteria
January 31, 2020
First Posted (Actual)
February 5, 2020
Study Record Updates
Last Update Posted (Actual)
February 5, 2020
Last Update Submitted That Met QC Criteria
February 3, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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