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

Georgia State University

Status: Invitation-only

Conditions: Sexual Assault; Alcohol Drinking

Treatments: Behavioral: A healthy lifestyles attention control; Behavioral: Positive Change (+Change) Plus Booster; Behavioral: Positive Change (+Change)

Study type: Interventional

Funder types: Other

Identifiers

NCT05281874

GeorgiaSU

Details and patient eligibility

About

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).

Full 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).

Enrollment: 3,300 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,300 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: A healthy lifestyles attention control

Positive Change (+Change)

Experimental group

Description:

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.

Treatment:

Behavioral: Positive Change (+Change)

Positive Change (+Change) Plus Booster

Experimental group

Description:

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.

Treatment:

Behavioral: Positive Change (+Change) Plus Booster