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

Primary Purpose

Alcohol Drinking, Social Norms, Expectations

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational standard
Educational standard and Harm prevention
Educational standard and Expectancies
Expectancies and Harm prevention
Educational standard and Normative perceptions
Normative perceptions and Harm prevention
Educational standard, Normative Perceptions, and Expectancies
Normative perceptions, Expectancies, and Harm Prevention
Sponsored by
Prevention Strategies, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Drinking

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Educational standard

    Educational standard and Harm prevention

    Educational standard and Expectancies

    Expectancies and Harm prevention

    Educational standard and Normative perceptions

    Normative perceptions and Harm prevention

    Educational standard, Normative Perceptions, and Expectancies

    Normative perceptions, Expectancies, and Harm Prevention

    Arm Description

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

    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.

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

    The aim of this arm is shift alcohol-related expectancies and increase intentions to use harm prevention strategies.

    The aim of this arm is to increase knowledge about alcohol and other drug use and correct erroneous alcohol-related normative perceptions.

    The aim of this arm is to correct erroneous alcohol-related normative perceptions and increase intentions to use harm prevention strategies.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    January 27, 2020
    Last Updated
    February 3, 2020
    Sponsor
    Prevention Strategies, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04253158
    Brief Title
    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

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2011 (Actual)
    Primary Completion Date
    May 31, 2016 (Actual)
    Study Completion Date
    May 31, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Prevention Strategies, LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Drinking, Social Norms, Expectations, Harm Reduction

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    3859 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Educational standard
    Arm Type
    Experimental
    Arm Description
    The aim of this arm is to increase knowledge about alcohol and other drug use.
    Arm Title
    Educational standard and Harm prevention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Educational standard and Expectancies
    Arm Type
    Experimental
    Arm Description
    The aim of this arm is to increase knowledge about alcohol and other drug use and shift alcohol-related expectancies.
    Arm Title
    Expectancies and Harm prevention
    Arm Type
    Experimental
    Arm Description
    The aim of this arm is shift alcohol-related expectancies and increase intentions to use harm prevention strategies.
    Arm Title
    Educational standard and Normative perceptions
    Arm Type
    Experimental
    Arm Description
    The aim of this arm is to increase knowledge about alcohol and other drug use and correct erroneous alcohol-related normative perceptions.
    Arm Title
    Normative perceptions and Harm prevention
    Arm Type
    Experimental
    Arm Description
    The aim of this arm is to correct erroneous alcohol-related normative perceptions and increase intentions to use harm prevention strategies.
    Arm Title
    Educational standard, Normative Perceptions, and Expectancies
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Normative perceptions, Expectancies, and Harm Prevention
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Educational standard
    Intervention Description
    Behavioral intervention aimed at increasing knowledge about alcohol and other drugs.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Educational standard and Harm prevention
    Intervention Description
    Behavioral intervention aimed at increasing knowledge about alcohol and other drugs increasing intentions to use harm prevention strategies.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Educational standard and Expectancies
    Intervention Description
    Behavioral intervention aimed at increasing knowledge about alcohol and other drugs and shifting alcohol-related expectancies.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Expectancies and Harm prevention
    Intervention Description
    Behavioral intervention aimed at correcting erroneous norms about alcohol use and shifting alcohol-related expectancies.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Educational standard and Normative perceptions
    Intervention Description
    Behavioral intervention aimed at increasing knowledge about alcohol and other drugs and correcting erroneous norms about alcohol use.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Normative perceptions and Harm prevention
    Intervention Description
    Behavioral intervention aimed at correcting erroneous norms about alcohol use and increasing intentions to harm prevention strategies.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Educational standard, Normative Perceptions, and Expectancies
    Intervention Description
    Behavioral intervention aimed at increasing knowledge about alcohol and other drugs, correcting erroneous norms about alcohol use, and shifting alcohol-related expectancies.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Normative perceptions, Expectancies, and Harm Prevention
    Intervention Description
    Behavioral intervention aimed at correcting erroneous norms about alcohol use, shifting alcohol-related expectancies, and increasing intentions to use harm prevention strategies.
    Primary Outcome Measure Information:
    Title
    Descriptive norms: DRINKING NORMS RATING FORM (adapted DNRF)
    Description
    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
    Title
    Injunctive norms:DRINKING NORMS RATING FORM (adapted DNRF)
    Description
    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
    Title
    Negative expectancies: COMPREHENSIVE EFFECTS OF ALCOHOL Scale (adapted CEOA)
    Description
    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
    Title
    Positive expectancies: COMPREHENSIVE EFFECTS OF ALCOHOL Scale (adapted CEOA)
    Description
    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 Outcome Measure Information:
    Title
    PROTECTIVE BEHAVIORAL STRATEGIES SCALE-20 (adapted - PBSS-20)
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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