An Online Intervention to Reduce E-cigarette Use and Cigarette Smoking Risk in Adolescents
2026년 5월 31일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
연구 유형
중재적
등록 (추정된)
150
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Denise Tran, Ph.D.
- 전화번호: 17145487785
- 이메일: denise.tran@med.usc.edu
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Days vaped in the past 7 days
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Vaping Quit Attempts
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2027년 3월 30일
연구 완료 (추정된)
2027년 3월 30일
연구 등록 날짜
최초 제출
2026년 5월 21일
QC 기준을 충족하는 최초 제출
2026년 5월 31일
처음 게시됨 (실제)
2026년 6월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 31일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- T35IP9813
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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.
IPD 공유 기간
Data will be available beginning 9 months and ending 36 months following article publication upon approval.
IPD 공유 액세스 기준
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.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .