Biomarker Feedback Intervention

An Examination of the Feasibility of a Brief Personalized Alcohol Biomarker Feedback Intervention for High-risk College Students

The goal of the study is to examine alcohol use behaviors of young adults through the use of testing the feasibility of adding an innovative brief personalized alcohol biomarker feedback component (TAC feedback) to an existing efficacious personalized feedback intervention, eCHECKUP TO GO (eCTG), and how (if at all) the intervention impacts drinking behaviors in high-risk college students. The study will conduct a feasibility assessment of the TAC feedback component, and will also assess the effects of the eCTG + TAC at 6-months post-baseline relative to an eCTG only group.

Study Overview

• Status: Not yet recruiting
• Conditions: College Student Drinking; High Risk Drinking
• Intervention / Treatment: Behavioral: eCHECKUP TO GO (eCTG); Behavioral: eCHECKUPTOGO + brief personalized alcohol biomarker feedback intervention (eCTG + TAC)

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kimberly Mallett, PhD; Phone Number: 814-441-6398; Email: kmallett@psu.edu
• Study Contact Backup: Name: Rob Turrisi, PhD; Phone Number: 814-865-7808; Email: rturrisi@psu.edu

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • The Pennsylvania State University
      • Contact: Kimberly Mallett, PhD; Phone Number: 814-441-6398; Email: kmallett@psu.edu
      • Contact: Rob Turrisi, PhD; Phone Number: 814-865-7808; Email: rturrisi@psu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Between the ages of 18-23 at enrollment
• Endorse drinking 4+/5+ (women/men) on a typical Friday or Saturday in the past 3-months
• Report at least 1 alcohol-induced blackout in the past 3-months
• Willing to wear a TAC sensor for 14 days at Waves 1 and 2

Exclusion Criteria:

• Younger than 18 at baseline
• Not fluent in English
• No Internet access

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eCHECKUP TO GO (eCTG); A brief, web-based program designed by San Diego State University to reduce high-risk drinking by providing personalized normative feedback regarding alcohol use, risk factors, and risks associated with drinking and accurate information about alcohol	Behavioral: eCHECKUP TO GO (eCTG); A brief, web-based program designed by San Diego State University to reduce high-risk drinking by providing personalized normative feedback regarding alcohol use, risk factors, and risks associated with drinking and accurate information about alcohol
Experimental: eCHECKUPTOGO + brief personalized biomarker feedback intervention (eCTG + TAC); Participants will receive the eCHECKUPTOGO in addition to the transdermal alcohol concentration (TAC) personalized feedback. The TAC is a brief individually delivered intervention based on the principles of Motivational Interviewing and focuses on increasing students' motivation to reduce harmful drinking by drinking in a safer, less risky manner. Participants will receive information on their drinking (both from the TAC sensor and daily diary data). Participants will be asked about drinking events during the past 2 weeks (how reflective they were of typical patterns and if a night stood out as particularly negative). Students will receive information and visual representations about TAC rise rates and peaks, and then be shown how their drinking during the past 2 weeks maps onto those visuals.	Behavioral: eCHECKUPTOGO + brief personalized alcohol biomarker feedback intervention (eCTG + TAC); Participants will receive the eCHECKUPTOGO in addition to the transdermal alcohol concentration (TAC) personalized feedback. The TAC is a brief individually delivered intervention based on the principles of Motivational Interviewing and focuses on increasing students' motivation to reduce harmful drinking by drinking in a safer, less risky manner. Participants will receive information on their drinking (both from the TAC sensor and daily diary data). Participants will be asked about drinking events during the past 2 weeks (how reflective they were of typical patterns and if a night stood out as particularly negative). Students will receive information and visual representations about TAC rise rates and peaks, and then be shown how their drinking during the past 2 weeks maps onto those visuals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examine changes in Transdermal Alcohol Concentration (TAC) rise rate	TAC rise rate will be collected via the BACtrack Skyn wrist sensor, which measures transdermal alcohol concentration (TAC) in micrograms of ethanol per liter of air every 20 seconds to obtain biomarkers - rise rate is a TAC increase.	Baseline, 6 months
Examine changes in Transdermal Alcohol Concentration (TAC) peak intoxication level	TAC peak will be collected via the BACtrack Skyn wrist sensor, which measures transdermal alcohol concentration (TAC) in micrograms of ethanol per liter of air every 20 seconds to obtain biomarkers - peak is the maximum TAC recorded per day.	Baseline, 6 months
Examine high risk drinking days	Heavy episodic drinking (HED) days are recorded when women indicate drinking 4+ drinks in 2 hour window/men indicate drinking 5+ drinks in 2 hour window. High-intensity drinking (HID) days are recorded when women indicate drinking 8+ drinks in 2 hour window/men indicate drinking 10+ drinks in 2 hour window.	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examine negative consequences of alcohol use	Alcohol related consequences (e.g., said or done embarrassing things) from the past 3 months will be measured using the established Brief Young Adult Alcohol Consequences Questionnaire. Response options will be on a 5-point scale ranging from (0) No or not in the past 3 months to (4) 4 or more times. Consequences will also be measures during the daily surveys on a Yes/No response scale.	Baseline, 6 months
Examine Alcohol Use Disorder (AUD) symptoms	Alcohol use disorder symptoms will be measured using the Alcohol Use Disorder Module of the SCID-5 and will be via in-person interview at baseline (past 12-months) and 6-month (past 6-months).	Baseline, 6 months

Collaborators and Investigators

• Sponsor: Penn State University
• Investigators: Principal Investigator: Kimberly Mallett, PhD, The Pennsylvania State University

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): May 15, 2027

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: college student drinking
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking; Behavior; Alcohol Drinking in College; Organic Chemicals; Alcohols; Ethanol
• Other Study ID Numbers: STUDY00027939

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: As part of funding requirements, data collected will be submitted to the NIAAA Data Archive.
• IPD Sharing Access Criteria: Individuals will request access to the data via a data access request through the data archive.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No