600 Participants Needed

Behavioral Intervention for Risky Behaviors in College Students

Recruiting at 2 trial locations
AE
Overseen ByAnne E Ray, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Anne E Ray
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this 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.

Research Team

AE

Anne E Ray, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for first-year college students at the University of Kentucky or UNT-Denton, aged 18-20, who have had a recent binge drinking episode and are sexually active but not in a monogamous relationship. It's not open to those pregnant, planning pregnancy, currently reducing substance use via treatment, or unable to consent.

Inclusion Criteria

Status as first-year college student at University of Kentucky or UNT-Denton

Exclusion Criteria

Currently in treatment to reduce alcohol or other substance use
I am unable or unwilling to agree to participate in this study.
Pregnant or planning to become pregnant
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Baseline Assessment

Participants complete a baseline survey during the first week of the semester

1 week
1 visit (in-person or virtual)

Intervention

Participants receive the PFI+CDF intervention with weekly dynamic feedback over 12 weeks

12 weeks
Weekly feedback (virtual)

Follow-up

Participants are monitored for changes in alcohol-related sexual behavior and other outcomes

13 months
Follow-up surveys at 1, 2, 3, 6, and 13 months

Treatment Details

Interventions

  • Cross-tailored Dynamic Feedback
  • Dynamic Feedback on General Health Behaviors
  • Personalized Feedback Intervention
Trial Overview The study tests an integrated feedback program aimed at reducing alcohol misuse and risky sexual behavior among college students. It combines personalized feedback with dynamic weekly updates based on daily behavior assessments over a period of 12 weeks.
Participant Groups
4Treatment groups
Experimental Treatment
Active Control
Group I: PFI-only with no diary surveysExperimental Treatment1 Intervention
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 II: PFI+GHI with diary surveysExperimental Treatment2 Interventions
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 III: PFI+CDF with diary surveysExperimental Treatment2 Interventions
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 IV: ControlActive Control1 Intervention
Participants in this condition get no intervention and do not complete weekend diary surveys.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Anne E Ray

Lead Sponsor

Trials
2
Recruited
660+

University of North Texas Health Science Center

Collaborator

Trials
41
Recruited
20,800+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials
865
Recruited
1,091,000+

Klein Buendel, Inc.

Industry Sponsor

Trials
41
Recruited
20,000+
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