Behavioral Intervention for Risky Behaviors in College Students

Not yet recruiting at 2 trial locations

Overseen By Anne E Ray, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Anne E Ray

Disqualifiers: Substance use treatment, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help first-year college students reduce risky behaviors linked to alcohol use and sexual activity. The study will test three approaches to providing feedback: a personalized feedback intervention (PFI), PFI with dynamic feedback (CDF), and PFI with general health information (GHI). Participants will receive weekly feedback about their behaviors to determine which method is most effective. Ideal participants are new college students who have noticed their drinking habits might lead to risky situations. As an unphased trial, this study offers a unique opportunity for students to gain personalized insights and improve their health habits.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently in treatment to reduce alcohol or other substance use, you cannot participate.

What prior data suggests that this behavioral intervention is safe for college students?

Research has shown that the Personalized Feedback Intervention (PFI) is safe and effective. This proven method helps reduce heavy drinking among college students. Studies have found that personalized feedback can lower risky drinking without negative side effects.

The Cross-tailored Dynamic Feedback (CDF) builds on PFI by using technology to regularly provide students with feedback on their drinking and related behaviors. Although specific safety data for CDF is limited, its combination with PFI suggests it should also be safe. This method aims to make feedback more engaging and interactive.

For the Dynamic Feedback on General Health Behaviors, specific safety data is unavailable. However, since it provides general health information and is not a drug or medical procedure, it is unlikely to cause harm.

Overall, these behavioral interventions are non-invasive and involve sharing feedback and information, which are generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions because they offer a personalized approach to reducing risky behaviors among college students. Unlike traditional methods that might provide generalized advice, these treatments deliver tailored feedback based on individual behaviors, like alcohol use and sexual activity. The Cross-tailored Dynamic Feedback (CDF) and Personalized Feedback Intervention (PFI) stand out by using personal data to guide participants in making healthier choices. Additionally, the use of weekend diary surveys in some arms allows for real-time self-reflection, potentially leading to more immediate behavioral changes. This innovative approach could lead to more effective and engaging strategies for promoting safer habits in young adults.

What evidence suggests that this trial's treatments could be effective for reducing risky behaviors in college students?

Research has shown that personalized feedback interventions (PFI) can effectively reduce risky sexual behaviors related to alcohol use in college students. One study found that students who received web-based PFI drank about 1.5 fewer drinks per week. In this trial, participants in one arm will receive a combination of PFI and cross-tailored dynamic feedback (CDF), which includes daily behavior checks and weekly feedback, to enhance the effectiveness of PFI. Early results suggest that CDF helps students better control their drinking and related risky behaviors by providing personalized, timely information. Together, these strategies aim to reduce both alcohol use and risky sexual behaviors, potentially lowering negative health outcomes for college students. ^{1 2 6 7 8}

Who Is on the Research Team?

Anne E Ray, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: PFI-only with no diary surveys Experimental Treatment 1 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 surveys Experimental Treatment 2 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 surveys Experimental Treatment 2 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: Control Active Control 1 Intervention

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

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10131715/

Cross-Tailoring Integrative Alcohol and Risky Sexual ... The aims of this study are to (1) evaluate the impact of a brief PFI that integrates content on alcohol use and RSB and is adapted to include a ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05011903

Integrative Alcohol and Risky Sex Feedback for College ... 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 ...

3. reporter.nih.gov reporter.nih.gov/search/eTg0t6BWBE-Fdv5Tngm2wQ/project-details/11030721

RePORT RePORTER - National Institutes of Health (NIH) | PROJECT NARRATIVE Alcohol misuse and related risky sexual behavior are significant public health concerns among college students. This project involves (1) ...

4. uknowledge.uky.edu uknowledge.uky.edu/ukcares_facpub/80/

"Cross-Tailoring Integrative Alcohol and Risky Sexual Behavior ... Cross-Tailoring Integrative Alcohol and Risky Sexual Behavior Feedback for College Students: Protocol for a Hybrid Type 1 Effectiveness-Implementation Trial ...

5. researchgate.net researchgate.net/publication/367559011_Cross-Tailoring_Integrative_Alcohol_and_Risky_Sexual_Behavior_Feedback_for_College_Students_Protocol_for_a_Hybrid_Type_1_Effectiveness-Implementation_Trial

(PDF) Cross-Tailoring Integrative Alcohol and Risky Sexual ... Cross-Tailoring Integrative Alcohol and Risky Sexual Behavior Feedback for College Students: Protocol for a Hybrid Type 1 Effectiveness-Implementation Trial.

6. scholars.uky.edu scholars.uky.edu/en/projects/cross-tailoring-integrative-alcohol-and-risky-sex-feedback-for-co/

Cross-Tailoring Integrative Alcohol and Risky Sex Feedback ... PROJECT SUMMARY/ABSTRACT Alcohol misuse and related risky sexual behavior (RSB) are significant public health concerns among college students.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36716301/

Cross-Tailoring Integrative Alcohol and Risky Sexual ... Cross-Tailoring Integrative Alcohol and Risky Sexual Behavior Feedback for College Students: Protocol for a Hybrid Type 1 Effectiveness- ...

8. trial.medpath.com trial.medpath.com/clinical-trial/521a1da8dcd1e7ec/cross-tailoring-alcohol-risky-sex-feedback

Integrative Alcohol and Risky Sex Feedback for College ... 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 ...