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Behavioral Intervention for Risky Behaviors in College Students

N/A
Waitlist Available
Led By Anne E Ray, PhD
Research Sponsored by Anne E Ray
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18-20 years old
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
Awards & highlights

Study Summary

This trial will test a new intervention to help college students who drink alcohol to also avoid risky sexual behavior.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
As this intervention involves behavioral feedback rather than medication, traditional physical side effects are not expected; however, participants may experience psychological impacts from confronting their behaviors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 20 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1-month, 2-month, 3-months, 6-months, and 13-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1-month, 2-month, 3-months, 6-months, and 13-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ethanol
Change in self-reported alcohol-related sexual behavior consequences
Change in self-reported alcohol-related sexual behavior frequency
+1 more
Secondary outcome measures
Change in self-reported alcohol use quantity
Change in self-reported condom use
Change in self-reported heavy episodic drinking
+1 more

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Personalized Feedback Intervention
2010
Completed Phase 2
~970

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
791 Previous Clinical Trials
1,356,384 Total Patients Enrolled
11 Trials studying Binge Drinking
4,190 Patients Enrolled for Binge Drinking
Anne E RayLead Sponsor
University of North Texas Health Science CenterOTHER
39 Previous Clinical Trials
19,572 Total Patients Enrolled

Media Library

Cross-tailored Dynamic Feedback Clinical Trial Eligibility Overview. Trial Name: NCT05011903 — N/A
Binge Drinking Research Study Groups: PFI+CDF with diary surveys, PFI+GHI with diary surveys, PFI-only with no diary surveys, Control
Binge Drinking Clinical Trial 2023: Cross-tailored Dynamic Feedback Highlights & Side Effects. Trial Name: NCT05011903 — N/A
Cross-tailored Dynamic Feedback 2023 Treatment Timeline for Medical Study. Trial Name: NCT05011903 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it still feasible to join this investigation?

"According to clinicaltrials.gov, this medical trial has closed its patient recruitment phase as of October 14th 2022. Having initially been posted on August 1st 2023, it is no longer searching for participants; however there are 262 other studies actively recruiting right now."

Answered by AI

Does your research include elderly participants?

"The enrollment parameters of this clinical trial require that participants are between 18 and 20 years old."

Answered by AI

What is the primary goal of this research project?

"According to Klein Buendel, Inc., the prime metric of this study is an evaluation of how self-reported alcohol-related sexual behavior outcomes alter over time. Baseline, 1 month, 2 months and 3 month data will be collected as well as 6 and 13 month results. Supplementary parameters include a consideration of typical number of drinks consumed on each day in the preceding four weeks; heavy drinking episodes (4+ for females 5+ for males) from last 4 weeks; and condom use frequency during intercourse in the same period."

Answered by AI

Are there any conditions that would disqualify me from partaking in this research?

"This clinical trial is searching for 600 participants, aged 18-20, who have had experiences with college drinking."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
What site did they apply to?
University of Kentucky
What portion of applicants met pre-screening criteria?
Did not meet criteria
~400 spots leftby Jan 2027