Integrative Alcohol and Risky Sex Feedback for College Students

November 29, 2023 updated by: Anne E Ray

Cross-Tailoring Integrative Alcohol and Risky Sex Feedback for College Students: A Hybrid Type 1 Effectiveness-Implementation Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University of Kentucky
        • Contact:
        • Principal Investigator:
          • Anne E Ray, PhD
        • Sub-Investigator:
          • Jerod L Stapleton, PhD
        • Sub-Investigator:
          • Seth Himelhoch, PhD
        • Sub-Investigator:
          • Heather Bush, PhD
    • Texas
      • Fort Worth, Texas, United States, 76107
        • University of North Texas Health Science Center at Fort Worth
        • Contact:
        • Principal Investigator:
          • Eun-Young Mun, PhD
        • Sub-Investigator:
          • Melissa A Lewis, PhD
        • Sub-Investigator:
          • Zhengyang Zhou, PhD
        • Sub-Investigator:
          • Dana M. Litt, PhD
        • Sub-Investigator:
          • Lin Tan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 20 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • the inability or unwillingness to give informed, voluntary consent to participate
  • not meeting inclusion criteria
  • currently in treatment to reduce alcohol or other substance use
  • pregnant or planning to become pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-reported alcohol-related sexual behavior frequency
Time Frame: 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
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported alcohol-related sexual behavior quantity
Time Frame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Number of alcoholic beverages consumed before sex in the last month
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported alcohol-related hook-ups
Time Frame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Number of alcohol-related hook-ups experienced in the last month
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported alcohol-related sexual behavior consequences
Time Frame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Number of alcohol-related sexual consequences experienced in the last month
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-reported alcohol use quantity
Time Frame: 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
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported heavy episodic drinking
Time Frame: 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
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported quantity of sex partners
Time Frame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Number of casual sex partners in the last month
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Change in self-reported condom use
Time Frame: Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Number of times condom was used during sex in the last month
Baseline, 1-month, 2-month, 3-months, 6-months, and 13-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anne E Ray

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Klein Buendel, Inc.
University of North Texas Health Science Center

Investigators

  • Principal Investigator: Anne E Ray, PhD, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

August 10, 2021

First Submitted That Met QC Criteria

August 16, 2021

First Posted (Actual)

August 18, 2021

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 62769
  • R01AA028246 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available to qualified researchers after the main findings are published in a peer-reviewed journal upon request. All data sharing will comply with local, state, and federal laws and regulations, including HIPAA Privacy and Security Rules. Data will be de-identified before presentations and publications, as well as any datasets shared with qualified researchers.

IPD Sharing Time Frame

To be determined.

IPD Sharing Access Criteria

To be determined.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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