Biomarker Feedback Intervention
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-23
SponsorPenn State University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Younger than 18 at baseline
Not fluent in English
No Internet access
Trial design
Design model
Parallel
Treatments tested in this trial
eCHECKUP TO GO (eCTG)
BehavioralA 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
eCHECKUPTOGO + brief personalized alcohol biomarker feedback intervention (eCTG + TAC)
BehavioralParticipants 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: eCHECKUP TO GO (eCTG)Experimental treatment 1 intervention
Group B: eCHECKUPTOGO + brief personalized biomarker feedback intervention (eCTG + TAC)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 6 months2
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.
Time frame
Baseline, 6 months3
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.
Time frame
Baseline, 6 monthsSecondary outcomes
1
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.
Time frame
Baseline, 6 months2
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).
Time frame
Baseline, 6 monthsSponsors and contacts
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Source ClinicalTrials.gov
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