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Enrolling by Invitation

NCT Number: NCT05281874

Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students

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).

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Key information

Conditions

Alcohol Drinking Behavior Drinking Behavior Sexual Assault

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia State University

Atlanta, Georgia, 30303, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive Change (+Change)

Behavioral

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.

A healthy lifestyles attention control

Behavioral

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.

Positive Change (+Change) Plus Booster

Behavioral

Positive Change (+Change) Plus Booster

Primary outcomes

  1. Changes in Alcohol use

    Time frame: 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

    Time frame: 3-, 6-, 9-, and 12-months

    Sexual assault victimization severity will be assessed using a modified version of the Sexual Experiences Survey. Responses are rated on number of times each experience occurred (0, 1, 2, 3+). Higher scores indicate higher sexual assault victimization.

  3. Changes in Bystander Intervention

    Time frame: 3-, 6-, 9-, and 12-months

    Bystander intervention behavior will be assessed using the 44-item Bystander Behavior Scale to assess engaging in bystander behavior with friends. Responses indicate if the participant engaged in each bystander behavior with a friend or not, or if they had no opportunity to engage in the behavior. Higher scores indicate higher bystander intervention behaviors.

  4. Changes in Sexual Assault Perpetration

    Time frame: 3-, 6-, 9-, and 12-months

    Sexual assault perpetration severity will be assessed using a modified version of the Sexual Strategies Survey. Participants check all items that apply. Higher scores indicate higher sexual assault perpetration.

Sponsors and collaborators

Lead sponsor

Georgia State University

Other

Collaborators

  • Arizona State University

Registry information

Acronym: +Change

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2022
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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