Personalized Integrated Alcohol and Sexual Assault Prevention Among College Students
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Positive Change (+Change), A healthy lifestyles attention control, Positive Change (+Change) Plus Booster.
- Who it may be relevant to
- Registry conditions: Alcohol Drinking, Sexual Assault. Basic parameters: 18 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
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).
Interventions
- 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. - 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. - Behavioral Positive Change (+Change) Plus Booster
Positive Change (+Change) Plus Booster
Primary outcome measures
- Changes in Alcohol use [Time frame: 3-, 6-, 9-, and 12-months]
- Changes in Sexual Assault Victimization [Time frame: 3-, 6-, 9-, and 12-months]
- Changes in Bystander Intervention [Time frame: 3-, 6-, 9-, and 12-months]
- Changes in Sexual Assault Perpetration [Time frame: 3-, 6-, 9-, and 12-months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Georgia State University — Atlanta
Identifiers
NCT: NCT05281874 · GeorgiaSU