Responses to Message Source and Presentation Using Psychophysiology

Identifying and Examining the Effects of Source and Presentation on Responses to Electronic Cigarette Public Education Messages in Young Adult Vapers and Non-vapers - Part 2

The goal of this clinical trial is to use psychophysiological methods to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape.

Study Overview

• Status: Completed
• Conditions: Vaping
• Intervention / Treatment: Other: Expert, one-sided; Other: Expert, two-sided; Other: Peer, one-sided; Other: Peer, two-sided

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • UMass Chan Medical School Shaw Building

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Ages 18-24
• Fluent in English
• Either vaping in the past 30 days or not having vaped in the past 30 days but susceptible to vaping
• Self-reported abstinence of combusted tobacco or marijuana at time of visit

Exclusion Criteria:

• Ages below 18 or above 24
• Not fluent in English
• Not confirmed self-reported abstinence of combusted tobacco or marijuana at time of visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Expert, one-sided; Participants assigned to the expert, one-sidedness condition will receive one-sided e-cigarette messages from an expert source.	Other: Expert, one-sided; Participants will view a brief description of an expert source and see one-sided e-cigarette education messages.
Experimental: Expert, two-sided; Participants assigned to the expert, two-sidedness condition will receive two-sided e-cigarette messages from an expert source.	Other: Expert, two-sided; Participants will view a brief description of an expert source and see two-sided e-cigarette education messages.
Experimental: Peer, one-sided; Participants assigned to the peer, one-sidedness condition will receive one-sided e-cigarette messages from a peer source.	Other: Peer, one-sided; Participants will view a brief description of a peer source and see one-sided e-cigarette education messages.
Experimental: Peer, two-sided; Participants assigned to the peer, two-sidedness condition will receive two-sided e-cigarette messages from a peer source.	Other: Peer, two-sided; Participants will view a brief description of a peer source and see two-sided e-cigarette education messages.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Attention	Visual attention was assessed by measuring dwell time, which is the length of time participants spent on looking at the specific areas of interest (AOIs) collected in miliseconds. Dwell time values were collected for 18 messages, and aggregated to provide the average dwell time scores for each arm. This was done for each vaping status (current vapers and susceptible non-vapers). Higher dwell time scores indicate higher visual attention, indicating better message outcomes.	The entire duration of message from beginning of its delivery to the completion of viewing, up to 45 minutes.
Allocation of Cognitive Resources	Heart rate values were collected in beats per minute (BPM) on a per-second basis during the presentation of each 18 distinct messages as well as during the immediately preceding black screen (baseline) for each message. Descriptive statistics were used to summarize changes in the BPM values during the message exposure period by comparing the BPM values collected during each message second to the BPM values collected during the immediately preceding baseline period. These change scores were then averaged across all messages within each study arm to generate a mean BPM value per condition, and this was done for each vaping status (current vapers and susceptible non-vapers). Lower BPM values reflect greater cognitive response, therefore indicate better message outcomes.	Baseline and immediately after viewing all the messages (approximately 45 minutes).
Arousal	Galvanic Skin Response (GSR) values were recorded in microsiemens on a per-second basis during the presentation of each 18 distinct messages as well as during the immediately preceding black screen (baseline) for each message. Descriptive statistics were used to summarize changes in GSR values by comparing each message response to its preceding baseline period. These change scores were then averaged across all messages within each study arm to generate a mean GSR score per condition, and this was done for each vaping status group (current vapers and susceptible non-vapers). Higher GSR values reflect greater physiological arousal, and indicate better message outcomes.	Baseline and immediately after viewing all the messages (approximately 45 minutes).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attitudes	Participants' self-reported vaping attitudes were measured by using a five-point bipolar scale using 7 subscale items assessing whether participants thought vaping was enjoyable, healthy, safe, fun, smart, cool, and attractive on a scale from 1 (negative attitudes) to 5 (positive attitudes). Items were summed and averaged to create a single composite score, and this was done for each arm for each vaping status. Higher scores indicate more positive e-cigarette attitudes, therefore worse outcomes.	After exposure to all messages, approximately up to 45 minutes.
Behavioral Intentions	Participants' vaping intentions was measured by using a 3 subscale items assessing participants' intentions to vape: soon/anytime during the next year/would use offered by one of their best friends, on a scale from 1 (Definitely not) to 5 (Definitely yes). Items were summed and averaged to create a single composite score. This was done for each vaping status (current vapers and susceptible non-vapers). Higher scores indicate greater vaping intentions, therefore indicating worse outcome.	After exposure to all messages, approximately up to 45 minutes.

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Donghee N Lee, PhD, University of Massachusetts, Worcester

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2024
• Primary Completion (Actual): June 10, 2024
• Study Completion (Actual): June 10, 2024

Study Registration Dates

• First Submitted: January 17, 2024
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00001223; 1K99CA281094-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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