Integrative Alcohol and Risky Sex Feedback for College Students

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Anne E Ray
Study ID
NCT05011903
Status
Not Yet Recruiting

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Conditions

  • Alcohol Drinking in College
  • Sexual Behavior

Eligibility Criteria

Sex
ALL
Age
18 Years - 20 Years
Healthy Volunteers
Accepted

Interventions

  • Cross-tailored Dynamic Feedback — BEHAVIORAL
    Dynamic, technology-delivered weekly feedback on weekend diary self-reports of first-year college student behavior related to alcohol use and related sexual behaviors.
  • Personalized Feedback Intervention — BEHAVIORAL
    Technology-delivered personalized feedback on first-year college student behavior related to alcohol use and related sexual behaviors.
  • Dynamic Feedback on General Health Behaviors — BEHAVIORAL
    Dynamic, technology-delivered weekly feedback on weekend diary self-reports of first-year college student behavior related to general health behaviors.

Study Details

Alcohol misuse and related risky sexual behaviors are significant health concerns for college students. Two-thirds of students are current drinkers, at least 1 in 3 report past month heavy episodic drinking (5+ drinks in a row), and 1 in 10 report high intensity drinking (10+ drinks in a row). Increased student alcohol use and heavy drinking are linked to increased sexual activity and related risky behaviors (e.g., unprotected sex, sex with casual partners). This puts students at risk for negative health outcomes (e.g., STIs - sexually transmitted infections) and is also a pathway to sexual victimization and escalated drinking. The first few weeks of college, known as the 'red zone,' provide an opportunity to intervene at time when these behaviors increase. However, most prevention programs for college students tend to focus on student alcohol use and have little to no integration of content on the relationship between alcohol use and risky sexual behaviors. This is an important gap in the literature and a priority area for NIAAA. The research team established the short-term efficacy of a personalized feedback intervention (PFI), a gold standard intervention approach, with integrated content on alcohol and risky sexual behaviors. In this study, we propose to extend our integrated PFI to include a cross-tailored dynamic feedback (CDF) component. The CDF component will use technology to incorporate daily assessments of student behavior and provide students with dynamic weekly feedback over 12 weeks. The goal is to increase the effectiveness of the integrated PFI and to create a program that is easily implemented on college campuses.

Key Dates

Start date
Apr 1, 2026
Status verified
Feb 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • 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.
  • 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.
  • 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.
  • No Intervention: Control
    Participants in this condition get no intervention and do not complete weekend diary surveys.

Primary Outcome Measure

Change in self-reported alcohol-related sexual behavior frequency [ Time Frame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40506
Anne E Ray, PhD
[email protected]
8592184944
Anne E Ray, PhD (PRINCIPAL_INVESTIGATOR)
Jerod L Stapleton, PhD (SUB_INVESTIGATOR)
Seth Himelhoch, PhD (SUB_INVESTIGATOR)
Heather Bush, PhD (SUB_INVESTIGATOR)
University of North Texas Health Science Center at Fort WorthFort WorthTexas76107
Eun-Young Mun, PhD
[email protected]
8177355158
Eun-Young Mun, PhD (PRINCIPAL_INVESTIGATOR)
Melissa A Lewis, PhD (SUB_INVESTIGATOR)
Zhengyang Zhou, PhD (SUB_INVESTIGATOR)
Dana M. Litt, PhD (SUB_INVESTIGATOR)
Lin Tan, PhD (SUB_INVESTIGATOR)

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