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Alcohol and Violence Prevention for College Students (ASAP)

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ClinicalTrials.gov Identifier: NCT04089137
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : October 2, 2019
Sponsor:
Collaborators:
Arizona State University
Medical University of South Carolina
Rhode Island Hospital
Information provided by (Responsible Party):
Amanda Gilmore, Georgia State University

Tracking Information
First Submitted Date  ICMJE August 27, 2019
First Posted Date  ICMJE September 13, 2019
Last Update Posted Date October 2, 2019
Actual Study Start Date  ICMJE March 15, 2018
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
  • Sexual Experiences Survey - Short Form Perpetration [ Time Frame: up to 90 days ]
    35 items total. Participants indicate the number of times that they did each act ranging from 0 (never) to 3 (3 or more times), with total scores ranging from 0 to 105 with greater scores indicating more perpetration. The mutually exclusive scoring system will be used. The goal is to count people only once according to the most severe act perpetrated.
  • Sexual Experiences Survey - Short Form Victimization [ Time Frame: up to 90 days ]
    35 items total, with total scores ranging from 0 to 105, with higher scores indicating more self-reported sexual assault victimization. The mutually exclusive scoring system will be used. The goal is to count people only once according to the most severe act experienced.
  • Alcohol Quantity Frequency Index [ Time Frame: up to 90 days ]
    Scale Range- Frequency: 0 to 4 (with increasing responses indicating increased frequency of alcohol use). Quantity: 0 to 5 (with higher numbers indicating higher use of alcohol) The maximum and minimum number of drinks that could be consumed is calculated for each combined quantity (the highest response category for the quantity question was allocated a score of 10) and frequency category. The mean of these two values represents the average number of standard drinks consumed/week. For example, three or four, two or three times a week is scored as nine standard drinks/week An additional question was utilized to assess heavy episodic drinking, "over the past month, how many times have you had 4 or more drinks for women, or 5 or more drinks for men, over a 2-hour period?" Responses ranged from: (min=0; max=undefined) Scores of 1 or higher indicated past-month heavy episodic drinking, with higher scores indicating increased frequency
  • Daily Drinking Questionnaire [ Time Frame: up to 90 days ]
    Participants indicate the number of drinks they consumed on each day of the week, during an average week (min=0; max=undefined). Frequency and quantity can be calculated based on participant scores Frequency: ranged from 0-7, with higher scores indicating increased frequency of drinking Quantity: ranged from 0 to undefined (max), based on the number of drinks consumed on day of the average week, with higher scores indicating increased quantity of drinking.
  • Drinking Context Scale [ Time Frame: up tp 90 days ]
    Scores for each item ranged from 1 (extremely low) to 5 (extremely high), with higher scores indicating increased probability of excessive drinking. The total scale includes 23 items, where summed scores range from 23 (minimum) to 115 (maximum). Subscale: Convivial Drinking (10 items) scores ranged from 10 (minimum) to 50 (maximum), with higher scores indicating increased likelihood of excessive drinking Subscale: Personal/Intimate Drinking (8 items) scores ranged from 8 (minimum) to 40 (maximum), with higher scores indicating increased likelihood of engaging in excessive drinking Subscale: Negative Coping (5 items) scores ranged from 5 (minimum) to 25 (maximum), with higher scores indicating increased likelihood of engaging in excessive drinking
  • Illinois Rape Myth Acceptance Scale [ Time Frame: up tp 90 days ]
    Scale Range: 45 items, scores ranging from 1 (minimum) to 7 (maximum) for each of the items, with total scores ranging from 45 (minimum) to 315 (maximum). Higher scores represented higher agreement with each statement, meaning higher scores indicating higher agreement with rape myth acceptance.
  • Drinking Norms Rating Form [ Time Frame: up to 90 days ]
    Scale Range: Participants indicated their perception of how much the typical-student of their gender consumes on each day of the week (min=0; max=undefined) Perception of frequency and quantity can be calculated based on participant score Frequency: range
  • Protective Behavioral Strategies [ Time Frame: up to 90 days ]
    Scale Range: 1 (minimum) to 5 (maximum); 25 items (total); ranging from 25 to 125, with higher scores indicating increased use of protective behavioral strategies Subscale: Limiting/Stopping Drinking (17 items). Scores ranged from 17 (minimum) to 85 (maximum), with higher scores indicating higher use of limiting/stopping drinking strategies Subscale: Manner of Drinking (5-items) Scores ranged from 5 (minimum) to 25 (maximum), with higher scores indicating increased use of manner of drinking strategies Subscale: Serious Harm Reduction (3 items) Scores ranged from 3 (minimum) to 15 (maximum), with higher scores indicating increased use of serious harm reduction drinking strategies
  • Sexual-Related Alcohol Expectancies [ Time Frame: up tp 90 days ]
    Scale Range: 18 items total, with scores total scores ranging from 18 to 108, with higher scores indicating higher sexual-related alcohol expectancies Subscale: Sexual Enhancement (5 items) scores ranged from 5 (minimum) to 30 (maximum), with higher scores indicating higher sexual-related alcohol expectancies for this domain. Subscale: Sexual Risk Taking (5 items) scores ranged from 5 (minimum) to to 30 (maximum), with higher scores indicating higher sexual-related alcohol expectancies for this domain. Subscale: Disinhibition (8 items), with scores ranging from 8 (minimum) to 48 (maximum), with higher scores indicating higher sexual-related alcohol expectancies for this domain.
  • Hypergender Ideology Scale [ Time Frame: up to 90 days ]
    Scale Range: 57 items total, with scores for each item ranging from 1 (minimum) to 6 (maximum), with total scale scores ranging from 57 (minimum) to 342 (maximum), with higher scores indicating higher endorsement of hypergender ideologies.
  • Bystander Behaviors Scale [ Time Frame: up to 90 days ]
    Scale Range: 51 items (total), with response options ranging from 0 (minimum) to 1 (maximum) for each of the items, with total scores ranging from 0 (minimum) to 51 (maximum), with higher scores indicating higher levels of past two-month engagement in prosocial behavior.
  • Intent to Help Scale [ Time Frame: up to 90 days ]
    Scale Range: 51 items (total), with response options ranging from 1 (minimum) to 5 (maximum), with total scores ranging from 51 (minimum) to 255 (maximum), with greater scores indicating higher intentions of intervening among peers.
  • Bystander Efficacy Scale [ Time Frame: up to 90 days ]
    Scale Range: 14 items total were included in this scale, with response options ranging from 0 % (minimum) to 100% (maximum) for each of the 14 items. Scores for this scale are created by subtracting the MEAN of these 14 items from 100 to create a scale of perceived ineffectiveness.
  • Bystander Attitudes Scale [ Time Frame: up to 90 days ]
    Scale Range: 51 items (total), with response options ranging from 1 (minimum) to 5 (maximum), for each item, with total scores ranging from 51 (minimum) to 255 (maximum), with higher scores indicating greater levels of prosocial attitudes. Scores for this scale are creating by summing responses across items
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
  • Alcohol use [ Time Frame: up to 90 days ]
    Average drinks per week and engagement in heavy episodic drinking will be used to assess alcohol use. This will be assessed using the daily drinking questionnaire
  • Sexual assault bystander intervention behavior [ Time Frame: up to 90 days ]
    Bystander intervention will be assessed using the Bystander Behavior Scale (BBS)
  • Sexual assault perpetration [ Time Frame: up to 90 days ]
    We will assess sexual assault perpetration using the Sexual Experiences Survey modified to assess the past 90 days (follow-up period)
  • Sexual assault victimization [ Time Frame: up to 90 days ]
    We will assess sexual assault victimization using the Sexual Experiences Survey modified to assess the past 90 days (follow-up period)
Change History Complete list of historical versions of study NCT04089137 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alcohol and Violence Prevention for College Students
Official Title  ICMJE Alcohol and Violence Prevention for College Students
Brief Summary Heavy episodic drinking and sexual assault (SA) are problematic on college campuses. This project will adapt already developed interventions targeting alcohol use and SA to a mHealth format and involve content that incorporates federal guidelines and CDC recommendations to integrate both bystander intervention and risk reduction content with new innovative personalized content for each risk group (cis-gender heterosexual men, cis-gender heterosexual women, and sexual/gender minorities). Alpha testing with key stakeholders, an open pilot trial, and a randomized pilot trial will be conducted to establish acceptability and to estimate sample size for a larger randomized controlled trial.
Detailed Description

Specific aims are as follows:

Aim 1 (Stage IA): Modify Alcohol and Sexual Assault Prevention (ASAP) content to an eHealth format to include personalized content for each risk group (1. cisgender heterosexual men; 2. cisgender heterosexual women; and 3. sexual and gender minorities).

Aim 1a: Assess normative behaviors (n = 500) regarding alcohol use and SA for feedback.

Aim 1b: Adapt and assess initial acceptability of a workbook version of the intervention content among key stakeholders (college administrators and students from each risk group [n=5 from each group]).

Aim 2 (Stage IB): Open Pilot Trial. Obtain usability of ASAP among 30 students who engage in HED (10 from each risk group) in an open pilot trial.

Aim 3 (Stage IB): A pilot to assess effect size and variability for planning a randomized trial in the future. Randomize students who engage in HED to ASAP or control condition to observe preliminary effect sizes and estimate the variability using a 3-month follow-up. Sample size was determined to estimate the variability within a reasonable margin of error. This calculation also accounted the low base rates of SA and 20% attrition. This led to a sample size of 162 students (n=54 from each risk group).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will receive an online intervention targeting alcohol misuse and sexual assault among college students. This will include a personalized normative feedback approach. In the first part of the study, there will be an open pilot (1 arm) and in the second part of the study there will be a control condition (2 arms - intervention + control)
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Alcohol Drinking
  • Sexual Assault
Intervention  ICMJE Behavioral: ASAP (Alcohol and Sexual Assault Prevention)
This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault.
Study Arms  ICMJE
  • No Intervention: Control
    This is an assessment only control condition.
  • Experimental: ASAP (Alcohol and Sexual Assault Prevention)
    This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault.
    Intervention: Behavioral: ASAP (Alcohol and Sexual Assault Prevention)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 11, 2019)
192
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2021
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-25 years old
  • Current student at university of study
  • Valid email address at university of study
  • Endorse engaging in heavy episodic drinking at least once in the past month on the screening survey

Exclusion Criteria:

  • There are no exclusion criteria other than not meeting inclusion criteria
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04089137
Other Study ID Numbers  ICMJE H20066
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No sharing of individual participant data, only de-identified data.
Responsible Party Amanda Gilmore, Georgia State University
Study Sponsor  ICMJE Georgia State University
Collaborators  ICMJE
  • Arizona State University
  • Medical University of South Carolina
  • Rhode Island Hospital
Investigators  ICMJE Not Provided
PRS Account Georgia State University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP