Integrative Alcohol and Risky Sex Feedback for College Students
Study Details
Study Description
Brief Summary
Alcohol misuse and related risky sexual behaviors are a significant public health concern among college students. Two-thirds of students are current drinkers, at least 1 in 3 report past month binge drinking (5+ drinks in a row), and 1 in 10 report high intensity drinking (10+ drinks in a row). Greater student alcohol consumption and heavy drinking on a given day is linked to increased sexual activity and RSB (e.g., unprotected sex, sex with casual partners). This puts students at risk for negative health outcomes (e.g., STIs) and is a pathway to sexual victimization and escalated drinking. The first few weeks of college, or the 'red zone,' present a critical window of opportunity to intervene for escalated alcohol use and associated risks, which can result in a potentially high public health and clinical impact. However, individual-level prevention strategies for college students tend to focus on students' alcohol use patterns and consequences more broadly, with little to no integration of content on the relationship between alcohol use and risky sexual behaviors, an important gap in the literature and a priority area for NIAAA. Our team previously established short-term efficacy of a personalized feedback intervention (PFI), a gold standard intervention approach, with integrated content on alcohol and risky sexual behaviors. We propose a cross-tailored dynamic feedback (CDF) intervention as an extension of the integrated PFI, which leverages technology to incorporate daily assessments of student behavior and provide them with dynamic weekly feedback to amplify the integrated PFI effects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The project utilizes a multisite, hybrid type 1 effectiveness-implementation study design to (1) evaluate the impact of CDF for at-risk first-year college students and (2) identify implementation factors critical to its success to facilitate future scale-up in campus settings. The first aim is to conduct a multi-level stakeholder-engaged adaptation of the integrated alcohol and risky sex PFI through the development and inclusion of CDF. The second aim is to conduct a randomized controlled trial (RCT) of the enhanced intervention (PFI+CDF) in a sample of 600 first-year college students who report recent binge drinking and are sexually active. Our primary hypothesis is that participants who receive the PFI+CDF intervention will report less alcohol use, fewer risky sexual behaviors, and fewer consequences relative to those who receive a PFI supplemented with generic health information at follow-up (1, 2, 3, 6, and 13 months). Participants (N=600 total, 300 per site) will be randomized to 1 of 4 groups: (1) PFI+CDF with weekend diary surveys, (2) PFI+GHI with weekend diary surveys, (3) PFI-only, no weekend diary surveys, and (4) assessment-only control, no weekend diary surveys. All participants will complete a baseline survey during the first week of the semester, be randomly assigned to condition, and complete follow-up surveys at 1, 2, 3, 6, and 13 months. This staggered design allows for comparison of the enhanced PFI+CDF relative to the PFI+GHI condition, which may be consistent with a "treatment-as-usual" comparison group (e.g., of the universities that have adopted an evidence-guided alcohol intervention program for their campus, many currently deliver commercialized alcohol-focused PFIs to incoming first-year students). Providing weekly GHI in the comparison condition allows for an equal number of "exposures" between the more intensive conditions (PFI+CDF vs. PFI+GHI), analogous to an attention control group, offering a clearer understanding of the overall impact of the PFI+CDF adaptation. The inclusion of two PFI conditions, one with weekend diary assessments and one without allows us to control for potential assessment reactivity that might result from the diary-style assessment approach. Overall, this design is intended to allow a separation of the "true" intervention effect of the CDF above and beyond the effect of assessment reactivity. The PFI-only vs. assessment-only control group comparison will provide a test of basic efficacy of the integrated PFI that has been adapted based on stakeholder feedback. Our third aim seeks to identify factors critical to PFI+CDF implementation in campus settings through conducting focus groups with a subset of students from the RCT and with local and national systems-level stakeholders. The intervention has strong potential for widespread dissemination and targets a group at high risk for alcohol misuse and RSB.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PFI+CDF with diary surveys Participants in this condition receive a Personalized Feedback Intervention (PFI) and Cross-tailored Dynamic Feedback (CDF) related to alcohol use and related sexual behavior. They also complete weekend diary surveys in which they are asked to self-report on weekend behaviors. |
Behavioral: Cross-tailored Dynamic Feedback
Dynamic, technology-delivered weekly feedback on weekend diary self-reports of first-year college student behavior related to alcohol use and related sexual behaviors.
Behavioral: Personalized Feedback Intervention
Technology-delivered personalized feedback on first-year college student behavior related to alcohol use and related sexual behaviors.
|
| Experimental: PFI+GHI with diary surveys Participants in this condition receive a Personalized Feedback Intervention (PFI) related to alcohol use and related sexual behavior, and generic health information (GHI). They also complete weekend diary surveys in which they are asked to self-report on weekend behaviors. |
Behavioral: Personalized Feedback Intervention
Technology-delivered personalized feedback on first-year college student behavior related to alcohol use and related sexual behaviors.
|
| Experimental: PFI-only with no diary surveys Participants in this condition receive a Personalized Feedback Intervention (PFI) related to alcohol use and related sexual behavior. They do not complete weekend diary surveys. |
Behavioral: Personalized Feedback Intervention
Technology-delivered personalized feedback on first-year college student behavior related to alcohol use and related sexual behaviors.
|
| No Intervention: Control Participants in this condition get no intervention and do not complete weekend diary surveys. |
Outcome Measures
Primary Outcome Measures
- Change in self-reported alcohol use quantity [Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months]
Typical number of drinks consumed on each day of week in the last month
- Change in self-reported heavy episodic drinking [Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months]
Number of heavy drinking episodes (4+ drinks female, 5+ drinks male) in the last month
- Change in self-reported high intensity drinking [Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months]
Number of high intensity drinking episodes (8+ drinks female, 10+ drinks male) in the last month
- Change in self-reported sexual behavior frequency [Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months]
How often participants reported having sex (including oral, vaginal or anal) in the last month
- Change in self-reported quantity of sex partners [Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months]
Number of casual sex partners in the last month
- Change in self-reported condom use [Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months]
Number of times condom was used during sex in the last month
- Change in self-reported alcohol-related sexual behavior frequency [Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months]
Number of times alcohol was consumed during or before sex in the last month
- Change in self-reported alcohol-related sexual behavior quantity [Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months]
Number of alcoholic beverages consumed before sex in the last month
Eligibility Criteria
Criteria
Inclusion Criteria:
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status as first-year college student at University of Kentucky or UNT-Denton
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18-20 years old
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one binge drinking episode within the past 30 days (4+/5+ drinks for women/men in one sitting)
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sexually active, defined as having oral, anal, or vaginal sex within the past 12 months
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not in a monogamous relationship (defined as single, not dating, or dating, not serious)
Exclusion Criteria:
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the inability or unwillingness to give informed, voluntary consent to participate
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not meeting inclusion criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Kentucky | Lexington | Kentucky | United States | 40506 |
| 2 | University of North Texas | Denton | Texas | United States | 76203 |
Sponsors and Collaborators
- Anne E Ray
- University of North Texas Health Science Center
- Klein Buendel, Inc.
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
- Principal Investigator: Anne E Ray, PhD, University of Kentucky
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R01AA028246
- R01AA028246