An Online Intervention to Reduce E-cigarette Use and Cigarette Smoking Risk in Adolescents
31 de mayo de 2026 actualizado por: Denise Tran, University of Southern California
An Online Intervention to Reduce E-cigarette Use and Potential for Cigarette Smoking in Adolescents
The goal of this clinical trial is to learn if a brief digital intervention can reduce e-cigarette use and prevent cigarette smoking initiation in teenagers ages 12-17. The main questions it aims to answer are:
- Compared to the control condition, does the intervention reduce e-cigarette use frequency in teenagers?
- Compared to the control condition, does the intervention reduce risk to start smoking cigarettes in teenagers? Researchers will compare the digital intervention to see if it leads to greater reductions in e-cigarette use and smoking risk than a waitlist control condition.
Participants will complete 5 brief online surveys across 12 weeks, and some will be selected to do a post-intervention virtual interview. In this interview, participants will be asked to share their opinions about the intervention and identify areas that need refinement.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
150
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Denise Tran, Ph.D.
- Número de teléfono: 17145487785
- Correo electrónico: denise.tran@med.usc.edu
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- be between the ages of 12 to 17
- be able to read English
- be a current resident of California
- report vaping at least one day per week in the past month
- report no history of cigarette use at screening and baseline
- have access to a computer or mobile device with internet access
Exclusion Criteria:
- currently receiving nicotine cessation services
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Digital vaping intervention
Virtual Intervention for Behavioral Empowerment (VIBE) is a one-time 30-minute online intervention that incorporates Personalized Normative Feedback (PNF) for vaping and smoking, motivational enhancement to encourage healthy behavior change, and vaping and smoking-related harms education.
Lastly, strategies recommended for nicotine cessation are presented.
This intervention can be completed in one sitting or split into multiple sessions and is delivered via an interactive website.
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The intervention contains Personalized Normative Feedback (PNF), motivational interviewing (MI), and education about vaping and smoking harms.
The program begins with the MI-based portion, which includes exploration of their experienced health and personal consequences of vaping and potential reasons for and motivation for shifting vaping behaviors (e.g., to save money, to be free from addiction).
Second, the education portion involves presentation of the actual harms posed by e-cigarettes to clarify any misperceptions of the negative effects of vaping and nicotine exposure in teens.
Next, users are presented with the PNF portion.
In the PNF portion, participants receive feedback about their perceptions of peer vaping by presenting their typical behavior/attitude alongside their perceptions of others' behavior/attitude alongside the actual norm of the behavior/attitude.
Lastly, strategies recommended for nicotine cessation are presented.
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Sin intervención: Waitlist control
Those in the control arm will be waitlisted and given the option to access VIBE (the intervention) at the end of study.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Days vaped in the past 7 days
Periodo de tiempo: Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
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Participants will report the number of days they vaped in the past 7 days.
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Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
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Times vape is picked up per day
Periodo de tiempo: Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
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Participants will report the number of times they picked up their device to vape per day in the past 7 days.
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Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
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Smoking Susceptibility
Periodo de tiempo: Past 7 day smoking susceptibility measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
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Smoking susceptibility will be assessed with the 4-item Expanded Susceptibility to Smoking Index, with the following responses: Definitely not, Probably not, Probably yes, and Definitely yes.
This is a binary outcome.
If a respondent answers "definitely not" to all four questions, they are categorized as not susceptible.
Any other response on any item flags the respondent as susceptible.
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Past 7 day smoking susceptibility measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Vaping Quit Attempts
Periodo de tiempo: Vaping quit attempts in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Quit attempts will be measured with questions asking for the number of quit attempts lasting at least 1 day since the last assessment.
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Vaping quit attempts in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Vaping Descriptive Normative Perceptions
Periodo de tiempo: Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Participants will report their beliefs regarding the percentage of teens who vaped, number of days individuals their age vaped, the number of times others their age picked up their vaping device per day in the past 30 days,
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Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Vaping Injunctive Normative Perceptions
Periodo de tiempo: Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Participants will report how much they believe others their age approve (or disapprove) of vaping using a 5-point Likert scale (responses options: Strongly disapprove to Strongly approve).
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Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Smoking Descriptive Normative Perceptions
Periodo de tiempo: Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Participants will report their beliefs about the percentage of teens who have smoked, the number of days others their age smoked in the past 30 days, and the quantity of cigarettes others their age smoked per day in the past 30 days.
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Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Smoking Injunctive Normative Perceptions
Periodo de tiempo: Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Participants will report how much they believe others their age approve (or disapprove) of cigarette smoking using a 5-point Likert scale (responses options: Strongly disapprove to Strongly approve).
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Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Quitting vaping self-efficacy
Periodo de tiempo: Self-efficacy in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Self-efficacy will be assessed by 2 adapted items that originally assessed self-efficacy to quit smoking.
Participants rate their confidence about quitting vaping "someday" and "in the next 6 months."
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Self-efficacy in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Motivation to Quit Vaping
Periodo de tiempo: Motivation to quit in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Motivation will be assessed by asking participants whether they were seriously thinking about quitting vaping with responses ranging from 1 = No, I am not thinking about quitting to 5 = Yes, I want to quit during the next 30 days.
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Motivation to quit in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
30 de marzo de 2027
Finalización del estudio (Estimado)
30 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
21 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
31 de mayo de 2026
Publicado por primera vez (Actual)
3 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- T35IP9813
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Individual participant data that underlie the results reported in this study, after de-identification, will be shared.
The Study Protocol and Statistical Analysis Plan will also be available.
Data will be available beginning 9 months and ending 36 months following article publication to researchers who provide a methodologically sound proposal to achieve the aims in the approved proposal.
Proposals must be approved by the Principal Investigator.
Please submit requests and usage plans to deniset@usc.edu.
Marco de tiempo para compartir IPD
Data will be available beginning 9 months and ending 36 months following article publication upon approval.
Criterios de acceso compartido de IPD
De-identified individual participant data will be shared with external researchers who submit a scientifically meritorious research proposal and a comprehensive Statistical Analysis Plan (SAP).
Data may be utilized for any secondary analysis or meta-analysis that contributes to public health knowledge.
Requests will be evaluated directly by the Principal Investigator.
Access is conditional upon the signing of a standard institutional Data Sharing Agreement.
Data files will be securely shared via email attachment or secure cloud download.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .