NCT04253158

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,859

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2016

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

4.8 years

First QC Date

January 27, 2020

Last Update Submit

February 3, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • PROTECTIVE BEHAVIORAL STRATEGIES SCALE-20 (adapted - PBSS-20)

    past 30-day

Study Arms (8)

Educational standard

EXPERIMENTAL

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

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.

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.

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.

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.

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.

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.

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.

Behavioral: Normative perceptions, Expectancies, and Harm Prevention

Interventions

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

Educational standard

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

Educational standard and Harm prevention

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

Educational standard and Expectancies

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

Expectancies and Harm prevention

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

Educational standard and Normative perceptions

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

Normative perceptions and Harm prevention

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

Educational standard, Normative Perceptions, and Expectancies

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

Normative perceptions, Expectancies, and Harm Prevention

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alcohol DrinkingHarm Reduction

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2020

First Posted

February 5, 2020

Study Start

September 1, 2011

Primary Completion

May 31, 2016

Study Completion

May 31, 2016

Last Updated

February 5, 2020

Record last verified: 2020-01