An Online Intervention to Reduce E-cigarette Use and Cigarette Smoking Risk in Adolescents
2026年5月31日 更新者：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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
150
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Denise Tran, Ph.D.
- 電話番号：17145487785
- メール：denise.tran@med.usc.edu
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
|
介入なし：Waitlist control
Those in the control arm will be waitlisted and given the option to access VIBE (the intervention) at the end of study.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Days vaped in the past 7 days
時間枠：Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
|
Participants will report the number of days they vaped in the past 7 days.
|
Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
|
|
Times vape is picked up per day
時間枠：Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
|
Participants will report the number of times they picked up their device to vape per day in the past 7 days.
|
Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
|
|
Smoking Susceptibility
時間枠：Past 7 day smoking susceptibility measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
|
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.
|
Past 7 day smoking susceptibility measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Vaping Quit Attempts
時間枠：Vaping quit attempts in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
Quit attempts will be measured with questions asking for the number of quit attempts lasting at least 1 day since the last assessment.
|
Vaping quit attempts in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
|
Vaping Descriptive Normative Perceptions
時間枠：Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
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,
|
Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
|
Vaping Injunctive Normative Perceptions
時間枠：Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
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).
|
Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
|
Smoking Descriptive Normative Perceptions
時間枠：Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
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.
|
Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
|
Smoking Injunctive Normative Perceptions
時間枠：Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
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).
|
Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
|
Quitting vaping self-efficacy
時間枠：Self-efficacy in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
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."
|
Self-efficacy in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
|
Motivation to Quit Vaping
時間枠：Motivation to quit in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
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.
|
Motivation to quit in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2027年3月30日
研究の完了 (推定)
2027年3月30日
試験登録日
最初に提出
2026年5月21日
QC基準を満たした最初の提出物
2026年5月31日
最初の投稿 (実際)
2026年6月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月3日
QC基準を満たした最後の更新が送信されました
2026年5月31日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- T35IP9813
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
Data will be available beginning 9 months and ending 36 months following article publication upon approval.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。