+Change: Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students

Sponsor
Georgia State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05281874
Collaborator
Arizona State University (Other)
3,300
3
45.5

Study Details

Study Description

Brief Summary

Heavy episodic drinking and sexual assault are problematic on college campuses. This study includes a randomized controlled trial of Positive Change (+Change), an integrated alcohol and sexual assault prevention program, compared to an attention-matched control condition across two universities in reducing alcohol use, sexual assault victimization, sexual assault perpetration, and increasing sexual assault bystander intervention. This study will also test the efficacy of +Change plus Booster session, an identical version of +Change delivered 6 months after the baseline, compared to +Change alone in long-term reductions in alcohol use, sexual assault victimization, sexual assault perpetration, and increases in sexual assault bystander intervention. This research is the next step of a NIAAA-funded planning grant (R34AA025691).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Positive Change (+Change)
  • Behavioral: A healthy lifestyles attention control
  • Behavioral: Positive Change (+Change) Plus Booster
N/A

Detailed Description

Aim 1: Test the efficacy of Positive Change (+Change) among college students in each risk group (cisgender heterosexual men; cisgender heterosexual women; LGBTQ). Students aged 18-25 who engage in heavy episodic drinking will be recruited from 2 large public universities (n = 3,300) and will be randomly assigned to +Change, +Change plus +Booster, or an attention control. Alcohol use, sexual assault (victimization and perpetration), and bystander intervention will be assessed at baseline, 3-, 6-, 9-, and 12-month follow-ups.

H1a: +Change conditions (+Change and +Change plus Booster) will result in less alcohol use, less sexual assault (victimization and perpetration), and more bystander intervention compared to the control condition at 3-month follow-up and maintained at 6 months.

H1b: +Change plus booster at 6-months will maintain less alcohol use, less sexual assault (victimization and perpetration), and more bystander intervention compared to +Change over 9- and 12-month follow-ups (i.e., less decay of change).

Aim 2: Investigate theoretical mechanisms through which +Change conditions impact alcohol use (e.g., descriptive drinking norms, drinking to cope with minority stress for LGBTQ students), sexual assault victimization and perpetration (e.g., sexual assault-related norms, sexual assault resistance self-efficacy, hypergender ideology), and bystander intervention (e.g., bystander intervention self-efficacy).

Exploratory Aim: Examine +Change efficacy among LGBTQ subgroups (lesbian, gay, bisexual, trans, non-binary gender, gender queer, queer/questioning, intersex, asexual).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Participants and principal investigator will be masked to intervention conditions.
Primary Purpose:
Prevention
Official Title:
Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students
Anticipated Study Start Date :
Aug 15, 2022
Anticipated Primary Completion Date :
May 31, 2026
Anticipated Study Completion Date :
May 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control

A healthy lifestyles attention control will be used as the control condition. We will match the control and intervention conditions on content (text, pictures, number of pages); type (interactive vs. psychoeducation); and average completion time.

Behavioral: A healthy lifestyles attention control
A healthy lifestyles attention control will be used as the control condition. We will match the control and intervention conditions on content (text, pictures, number of pages); type (interactive vs. psychoeducation); and average completion time.

Experimental: Positive Change (+Change)

This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. It targets alcohol, sexual assault victimization risk, sexual assault perpetration, and bystander intervention. It is tailored by gender and sexual orientation.

Behavioral: Positive Change (+Change)
This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. It targets alcohol, sexual assault victimization risk, sexual assault perpetration, and bystander intervention. It is tailored by gender and sexual orientation.

Experimental: Positive Change (+Change) Plus Booster

This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault. It targets alcohol, sexual assault victimization risk, sexual assault perpetration, and bystander intervention. It is tailored by gender and sexual orientation. It is provided at baseline and a booster at 6 months.

Behavioral: Positive Change (+Change) Plus Booster
Positive Change (+Change) Plus Booster

Outcome Measures

Primary Outcome Measures

  1. Changes in Alcohol use [3-, 6-, 9-, and 12-months]

    Number of drinks will be assessed using the daily drinking questionnaire. Higher scores indicate higher alcohol use.

  2. Changes in Sexual Assault Victimization [3-, 6-, 9-, and 12-months]

    Sexual assault victimization severity will be assessed using the Sexual Experiences Survey. Responses are rated on a 4-point scale. Higher scores indicate higher sexual assault victimization.

  3. Changes in Bystander Intervention [3-, 6-, 9-, and 12-months]

    Bystander intervention behavior will be assessed using the 44-item Bystander Behavior Scale. Responses are rated on a 3-point scale. Higher scores indicate higher bystander intervention behaviors.

  4. Changes in Sexual Assault Perpetration [3-, 6-, 9-, and 12-months]

    Sexual assault perpetration severity will be assessed using the 23-item Sexual Strategies Survey. Participants check all items that apply. Higher scores indicate higher sexual assault perpetration.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Georgia State University
  • Arizona State University

Investigators

  • Principal Investigator: Amanda Gilmore, PhD, Georgia State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amanda Gilmore, Assistant Professor, Georgia State University
ClinicalTrials.gov Identifier:
NCT05281874
Other Study ID Numbers:
  • GeorgiaSU
First Posted:
Mar 16, 2022
Last Update Posted:
Mar 16, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 16, 2022