ClinicalTrials.gg
CompletedNCT04253158Updated Feb 5, 2020

Implementation of a Web-based Alcohol and Other Drug Prevention Intervention for Collegiate Student-athletes

An interventional study of Educational standard and Educational standard and Harm prevention in Alcohol Drinking, Social Norms and Expectations, sponsored by Prevention Strategies, LLC. Completed. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-05.

Primary conditionHarm ReductionRegistry: Alcohol DrinkingReclassifiedWhy we changed it
Registry
Alcohol Drinking — the first condition term the registry derived for this study.
ClinicalTrials.gg
Harm Reduction
Why
  1. Alcohol Drinking is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Harm Reduction.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Prevention Strategies, LLC · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 8 years 4 months after the study started (first participant enrolled Sep 2011, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
3,859
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Alcohol Drinking
  • Social Norms
  • Expectations
  • Harm Reduction

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03

In context

Harm Reduction Reclassified

115 studies on the registry are indexed under Harm Reduction; 39 are open to participants now.

This study's enrollment of 3,859 is above the median of 139 across 92 interventional studies indexed under Harm Reduction.

Browse Harm Reduction studies →

Lead sponsor

Prevention Strategies, LLC is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Compared within Harm Reduction, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Alcohol Drinking. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 criteria

Exclusion

  • equal to or less than 17 years of age
  • greater than 25 years of age
  • non-NCAA sponsored athlete
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
3,859 participants (actual)

Study arms

  • Experimental
    Educational standard

    The aim of this arm is to increase knowledge about alcohol and other drug use.

    Behavioral: Educational standard

  • 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: Educational standard and Harm prevention

  • 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: Educational standard and 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: Expectancies and Harm prevention

  • 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: Educational standard and Normative perceptions

  • 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: Normative perceptions and Harm prevention

  • 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: Educational standard, Normative Perceptions, and 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: Normative perceptions, Expectancies, and Harm Prevention

Interventions

  • BehavioralEducational standard

    Behavioral intervention aimed at increasing knowledge about alcohol and other drugs.

  • BehavioralEducational standard and Harm prevention

    Behavioral intervention aimed at increasing knowledge about alcohol and other drugs increasing intentions to use harm prevention strategies.

  • BehavioralEducational standard and Expectancies

    Behavioral intervention aimed at increasing knowledge about alcohol and other drugs and shifting alcohol-related expectancies.

  • BehavioralExpectancies and Harm prevention

    Behavioral intervention aimed at correcting erroneous norms about alcohol use and shifting alcohol-related expectancies.

  • BehavioralEducational standard and Normative perceptions

    Behavioral intervention aimed at increasing knowledge about alcohol and other drugs and correcting erroneous norms about alcohol use.

  • BehavioralNormative perceptions and Harm prevention

    Behavioral intervention aimed at correcting erroneous norms about alcohol use and increasing intentions to harm prevention strategies.

  • BehavioralEducational standard, Normative Perceptions, and Expectancies

    Behavioral intervention aimed at increasing knowledge about alcohol and other drugs, correcting erroneous norms about alcohol use, and shifting alcohol-related expectancies.

  • BehavioralNormative perceptions, Expectancies, and Harm Prevention

    Behavioral intervention aimed at correcting erroneous norms about alcohol use, shifting alcohol-related expectancies, and increasing intentions to use harm prevention strategies.

06

What researchers measure

Primary outcomes

  1. Descriptive norms: DRINKING NORMS RATING FORM (adapted DNRF)

    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.

    Time frame: past 30-day

  2. Injunctive norms:DRINKING NORMS RATING FORM (adapted DNRF)

    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.

    Time frame: past 30-day

  3. Negative expectancies: COMPREHENSIVE EFFECTS OF ALCOHOL Scale (adapted CEOA)

    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.

    Time frame: past 30-day

  4. Positive expectancies: COMPREHENSIVE EFFECTS OF ALCOHOL Scale (adapted CEOA)

    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.

    Time frame: past 30-day

Secondary outcomes

  1. PROTECTIVE BEHAVIORAL STRATEGIES SCALE-20 (adapted - PBSS-20)

    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.

    Time frame: past 30-day

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2011 to primary completion in May 2016, 56 months.

Of 57 interventional studies with no phase under Harm Reduction, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 43. This study's 56 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2020
First posted
Feb 5, 2020
StartActual
Sep 1, 2011
Primary completionActual
May 31, 2016
CompletionActual
May 31, 2016
Last update
Feb 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04253158
Lead sponsor
Prevention Strategies, LLC
Responsible party
Sponsor
First posted
Feb 5, 2020
Start date
Sep 1, 2011
Primary completion
May 31, 2016
Completion
May 31, 2016
Last update
Feb 5, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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