NCT07129265

Brief Summary

The purpose of this study is to develop an electronic cigarette (e-cigarette) counter-marketing lesson for adolescents. The lesson will involve short videos designed to improve adolescents' cognition of e-cigarette marketing in the retail environment with the overall goal of reducing their susceptibility to use, intent to use, and actual use of e-cigarettes. Through this study, the study team will identify and refine the key messages that would make this lesson acceptable, feasible to implement, and effective in altering e-cigarette-related perceptions and potentially behaviors.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
12mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress44%
Aug 2025Apr 2027

Study Start

First participant enrolled

August 4, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 5, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

1.7 years

First QC Date

August 5, 2025

Last Update Submit

August 11, 2025

Conditions

Keywords

e-cigarettevapingtobacconicotineadolescentcounter-marketingdigital contentdigital education interventions

Outcome Measures

Primary Outcomes (1)

  • Development of an e-cigarette counter-marketing lesson focused on the retail environment

    Key messages and message-delivery strategy will be developed, potentially comprising of short-form videos. The study team will ask working group members to rank draft messages and strategies for delivery in addition to eliciting qualitative information.

    At 6 months

Other Outcomes (14)

  • Feasibility: Preferred recruitment advertisement

    Baseline (pre-focus group)

  • Acceptability: Relevance to population(s)

    During baseline focus group

  • Acceptability: Desired improvements

    During baseline focus group

  • +11 more other outcomes

Study Arms (2)

Working group members

10 members of the expert working group: 2 middle school students, 2 high school students, 2 young adults, 1 educator, 1 parent, and 4 curriculum design expert

Other: Working group

Focus group participants

36 adolescent/young adult participants

Other: Focus group

Interventions

Participants will: 1) take a 10-min demographic survey; 2) join 3 x 60-min working group meetings in which they will review preliminary results, collaborate on curriculum design, and provide feedback; and 3) respond to prompts in 3 emails (approx 5-10 mins each).

Working group members

Participants will take a 10-min demographic survey and join 1 x 30-min focus group meeting in which they will provide feedback on the curriculum in development.

Focus group participants

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will include individuals residing in the U.S. There will be 10 members of the expert working group (2 middle, 2 high school students, 2 young adults, 1 educator, 1 parent, and 4 curriculum design experts). There will be 36 adolescent and young adult participants of the focus groups.

You may qualify if:

  • Youth participants:
  • Middle school students may be 13-15 years
  • High schoolers may be 16-18 years
  • Young adults may be 19-29 years
  • Provide a phone number for at least one backup contact (e.g, parent/guardian)
  • Curriculum design experts:
  • Experience of at least 1 year in tobacco prevention or relevant public health field
  • Parent:
  • Parent of a child who has e-cigarette use history or is currently using (preferred, but not essential)
  • Educator:
  • Currently employed as teacher at a middle/high school All participants
  • Provide their cell phone number and email address
  • Fluent in English

You may not qualify if:

  • Express inability to participate consistently across study working group meetings.
  • FOCUS GROUP PARTICIPANTS
  • Adolescents and young adults ages 13-21 years
  • Fluent in English
  • Provide their cell phone number and email address
  • Provide a phone number for at least one backup contact

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

VapingAdolescent Behavior

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

SmokingBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty Researcher

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 19, 2025

Study Start

August 4, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

De-identified participant survey data will be made available.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
De-identified data will be made available only after study publication (between 14-24 months after the end of the study).
Access Criteria
The Principal Investigator will provide data to those who indicate that they have received approval from an Institutional Review Board (IRB) or appropriate ethics committee, and execute a data use/sharing agreement.

Locations