Alcohol DrinkingNCT04253158
Implementation of a Web-based Alcohol and Other Drug Prevention Intervention for Collegiate Student-athletes
A study testing Educational standard, Educational standard and Harm prevention and Educational standard and Expectancies in people with Alcohol Drinking and Social Norms, run by Prevention Strategies, LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Social Norms, Expectations
- What is being tested?
- Educational standard, Educational standard and Harm prevention and Educational standard and Expectancies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,859 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2011to 31 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- equal to or less than 17 years of age
- greater than 25 years of age
- non-NCAA sponsored athlete
About this study
Official title: 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).
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.
- Conditions
- Alcohol Drinking, Social Norms, Expectations, Harm Reduction
- Being tested
- Educational standard, Educational standard and Harm prevention, Educational standard and Expectancies, Expectancies and Harm prevention, Educational standard and Normative perceptions
- Medical subject headings
- Alcohol Drinking, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational standardBehavioural
Behavioral intervention aimed at increasing knowledge about alcohol and other drugs.
Educational standard and Harm preventionBehavioural
Behavioral intervention aimed at increasing knowledge about alcohol and other drugs increasing intentions to use harm prevention strategies.
Educational standard and ExpectanciesBehavioural
Behavioral intervention aimed at increasing knowledge about alcohol and other drugs and shifting alcohol-related expectancies.
Expectancies and Harm preventionBehavioural
Behavioral intervention aimed at correcting erroneous norms about alcohol use and shifting alcohol-related expectancies.
Educational standard and Normative perceptionsBehavioural
Behavioral intervention aimed at increasing knowledge about alcohol and other drugs and correcting erroneous norms about alcohol use.
Normative perceptions and Harm preventionBehavioural
Behavioral intervention aimed at correcting erroneous norms about alcohol use and increasing intentions to harm prevention strategies.
Educational standard, Normative Perceptions, and ExpectanciesBehavioural
Behavioral intervention aimed at increasing knowledge about alcohol and other drugs, correcting erroneous norms about alcohol use, and shifting alcohol-related expectancies.
Normative perceptions, Expectancies, and Harm PreventionBehavioural
Behavioral intervention aimed at correcting erroneous norms about alcohol use, shifting alcohol-related expectancies, and increasing intentions to use harm prevention strategies.
| Study group | Role | What they receive |
|---|---|---|
| Educational standard | Experimental | The aim of this arm is to increase knowledge about alcohol and other drug use. Receives: Behavioral: Educational standard |
| Educational standard and Harm prevention | Experimental | 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. Receives: Behavioral: Educational standard and Harm prevention |
| Educational standard and Expectancies | Experimental | The aim of this arm is to increase knowledge about alcohol and other drug use and shift alcohol-related expectancies. Receives: Behavioral: Educational standard and Expectancies |
| Expectancies and Harm prevention | Experimental | The aim of this arm is shift alcohol-related expectancies and increase intentions to use harm prevention strategies. Receives: Behavioral: Expectancies and Harm prevention |
| Educational standard and Normative perceptions | Experimental | The aim of this arm is to increase knowledge about alcohol and other drug use and correct erroneous alcohol-related normative perceptions. Receives: Behavioral: Educational standard and Normative perceptions |
| Normative perceptions and Harm prevention | Experimental | The aim of this arm is to correct erroneous alcohol-related normative perceptions and increase intentions to use harm prevention strategies. Receives: Behavioral: Normative perceptions and Harm prevention |
| Educational standard, Normative Perceptions, and Expectancies | Experimental | 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. Receives: Behavioral: Educational standard, Normative Perceptions, and Expectancies |
| Normative perceptions, Expectancies, and Harm Prevention | Experimental | 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. Receives: Behavioral: Normative perceptions, Expectancies, and Harm Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: past 30-day
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.
Measured: past 30-day
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.
Measured: past 30-day
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.
Measured: 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.
Measured: past 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Sep 2011
- Primary completion31 May 2016
- Study completion31 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 3,859 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prevention Strategies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253158
- Sponsor's protocol ID
- 1011
- Status last verified
- Jan 2020
- First submitted
- 27 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug and Alcohol Prevention for College Athletes
- ClinicalTrials.gov ID
- NCT04253158
- Acronym / sponsor ID
- 1011
- Conditions
- Alcohol Drinking, Social Norms, Expectations, Harm Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,859 participants (actual)
- Lead sponsor
- Prevention Strategies, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2011 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 31 May 2016 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Educational standard | Experimental | Behavioral: Educational standardThe aim of this arm is to increase knowledge about alcohol and other drug use. |
| Educational standard and Harm prevention | Experimental | Behavioral: Educational standard and Harm preventionThe aim of this arm is to increase knowledge about alcohol and other drug use and increase intentions for the use of harm prevention strategies. |
| Educational standard and Expectancies | Experimental | Behavioral: Educational standard and ExpectanciesThe aim of this arm is to increase knowledge about alcohol and other drug use and shift alcohol-related expectancies. |
| Expectancies and Harm prevention | Experimental | Behavioral: Expectancies and Harm preventionThe aim of this arm is shift alcohol-related expectancies and increase intentions to use harm prevention strategies. |
| Educational standard and Normative perceptions | Experimental | Behavioral: Educational standard and Normative perceptionsThe aim of this arm is to increase knowledge about alcohol and other drug use and correct erroneous alcohol-related normative perceptions. |
| Normative perceptions and Harm prevention | Experimental | Behavioral: Normative perceptions and Harm preventionThe aim of this arm is to correct erroneous alcohol-related normative perceptions and increase intentions to use harm prevention strategies. |
| Educational standard, Normative Perceptions, and Expectancies | Experimental | Behavioral: Educational standard, Normative Perceptions, and ExpectanciesThe 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. |
| Normative perceptions, Expectancies, and Harm Prevention | Experimental | Behavioral: Normative perceptions, Expectancies, and Harm PreventionThe aim of this arm is to correct erroneous alcohol-related normative perceptions, shift alcohol-related expectancies, and increase intentions to use harm prevention strategies. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- equal to or less than 17 years of age
- greater than 25 years of age
- non-NCAA sponsored athlete
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational standardBehavioral intervention aimed at increasing knowledge about alcohol and other drugs. | Behavioural | Educational standard |
| Educational standard and Harm preventionBehavioral intervention aimed at increasing knowledge about alcohol and other drugs increasing intentions to use harm prevention strategies. | Behavioural | Educational standard and Harm prevention |
| Educational standard and ExpectanciesBehavioral intervention aimed at increasing knowledge about alcohol and other drugs and shifting alcohol-related expectancies. | Behavioural | Educational standard and Expectancies |
| Expectancies and Harm preventionBehavioral intervention aimed at correcting erroneous norms about alcohol use and shifting alcohol-related expectancies. | Behavioural | Expectancies and Harm prevention |
| Educational standard and Normative perceptionsBehavioral intervention aimed at increasing knowledge about alcohol and other drugs and correcting erroneous norms about alcohol use. | Behavioural | Educational standard and Normative perceptions |
| Normative perceptions and Harm preventionBehavioral intervention aimed at correcting erroneous norms about alcohol use and increasing intentions to harm prevention strategies. | Behavioural | Normative perceptions and Harm prevention |
| Educational standard, Normative Perceptions, and ExpectanciesBehavioral intervention aimed at increasing knowledge about alcohol and other drugs, correcting erroneous norms about alcohol use, and shifting alcohol-related expectancies. | Behavioural | Educational standard, Normative Perceptions, and Expectancies |
| Normative perceptions, Expectancies, and Harm PreventionBehavioral intervention aimed at correcting erroneous norms about alcohol use, shifting alcohol-related expectancies, and increasing intentions to use harm prevention strategies. | Behavioural | Normative perceptions, Expectancies, and Harm Prevention |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
PROTECTIVE BEHAVIORAL STRATEGIES SCALE-20 (adapted - PBSS-20)
Time frame: past 30-day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Educational standard, Educational standard and Harm prevention and Educational standard and Expectancies in people with Alcohol Drinking and Social Norms, run by Prevention Strategies, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive norms: DRINKING NORMS RATING FORM (adapted DNRF) (time frame: past 30-day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.