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Integrative Alcohol and Risky Sex Feedback for College Students

NCT ID: NCT05011903

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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The project utilizes a multisite, hybrid type 1 effectiveness-implementation study design to (1) evaluate the impact of CDF for 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. The 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. The 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.

Conditions

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Alcohol Drinking in College Sexual Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Cross-tailored Dynamic Feedback

Intervention Type 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

Intervention Type BEHAVIORAL

Technology-delivered personalized feedback on first-year college student behavior related to alcohol use and related sexual behaviors.

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.

Group Type EXPERIMENTAL

Personalized Feedback Intervention

Intervention Type 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

Intervention Type BEHAVIORAL

Dynamic, technology-delivered weekly feedback on weekend diary self-reports of first-year college student behavior related to general health behaviors.

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.

Group Type EXPERIMENTAL

Personalized Feedback Intervention

Intervention Type BEHAVIORAL

Technology-delivered personalized feedback on first-year college student behavior related to alcohol use and related sexual behaviors.

Control

Participants in this condition get no intervention and do not complete weekend diary surveys.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Personalized Feedback Intervention

Technology-delivered personalized feedback on first-year college student behavior related to alcohol use and related sexual behaviors.

Intervention Type BEHAVIORAL

Dynamic Feedback on General Health Behaviors

Dynamic, technology-delivered weekly feedback on weekend diary self-reports of first-year college student behavior related to general health behaviors.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* status as first-year college student at University of Kentucky or UNT-Denton
* 18-20 years old

* currently in treatment to reduce alcohol or other substance use
* pregnant or planning to become pregnant

Exclusion Criteria

* the inability or unwillingness to give informed, voluntary consent to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Texas Health Science Center

OTHER

Sponsor Role collaborator

Klein Buendel, Inc.

INDUSTRY

Sponsor Role collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Anne E Ray

OTHER

Sponsor Role lead

Responsible Party

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Anne E Ray

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anne E Ray, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

University of North Texas Health Science Center at Fort Worth

Fort Worth, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Anne E Ray, PhD

Role: CONTACT

Phone: 8592184944

Email: [email protected]

Facility Contacts

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Anne E Ray, PhD

Role: primary

Eun-Young Mun, PhD

Role: primary

References

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Ray AE, Mun EY, Lewis MA, Litt DM, Stapleton JL, Tan L, Buller DB, Zhou Z, Bush HM, Himelhoch S. Cross-Tailoring Integrative Alcohol and Risky Sexual Behavior Feedback for College Students: Protocol for a Hybrid Type 1 Effectiveness-Implementation Trial. JMIR Res Protoc. 2023 Mar 20;12:e43986. doi: 10.2196/43986.

Reference Type DERIVED
PMID: 36716301 (View on PubMed)

Other Identifiers

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R01AA028246

Identifier Type: NIH

Identifier Source: secondary_id

View Link

62769

Identifier Type: -

Identifier Source: org_study_id