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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04253158
Other study ID # 1011
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2011
Est. completion date May 31, 2016

Study information

Verified date January 2020
Source Prevention Strategies, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 3859
Est. completion date May 31, 2016
Est. primary completion date May 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Educational standard
Behavioral intervention aimed at increasing knowledge about alcohol and other drugs.
Educational standard and Harm prevention
Behavioral intervention aimed at increasing knowledge about alcohol and other drugs increasing intentions to use harm prevention strategies.
Educational standard and Expectancies
Behavioral intervention aimed at increasing knowledge about alcohol and other drugs and shifting alcohol-related expectancies.
Expectancies and Harm prevention
Behavioral intervention aimed at correcting erroneous norms about alcohol use and shifting alcohol-related expectancies.
Educational standard and Normative perceptions
Behavioral intervention aimed at increasing knowledge about alcohol and other drugs and correcting erroneous norms about alcohol use.
Normative perceptions and Harm prevention
Behavioral intervention aimed at correcting erroneous norms about alcohol use and increasing intentions to harm prevention strategies.
Educational 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.
Normative 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Prevention Strategies, LLC

Outcome

Type Measure Description Time frame Safety issue
Primary 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. past 30-day
Primary 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. past 30-day
Primary 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. past 30-day
Primary 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. past 30-day
Secondary 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. past 30-day
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