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出境医 / 临床实验 / Text Message Quit Vaping Intervention for Adolescents

Text Message Quit Vaping Intervention for Adolescents

Study Description
Brief Summary:
This research study, conducted by Truth Initiative, will help us learn how text messaging can help adolescents between 13 and 17 years of age quit vaping.

Condition or disease Intervention/treatment Phase
Vaping Cessation, Tobacco Behavioral: This is Quitting Other: Assessment only control Not Applicable

Detailed Description:
The Teen Quit Vaping Study (QVS Teen)'s primary aim is to conduct a fully powered comparative effectiveness trial to evaluate the effectiveness of a quit vaping text message program in promoting abstinence from e-cigarettes among young users aged 13-17. This study is a 3-arm randomized controlled trial conducted among young users aged 13-17 recruited through online channels. Participants will be randomized to a quit vaping text message intervention, an assessment-only control condition, and a minimal contact control condition and followed for 7 months to roughly correspond to 6-months post-treatment. The secondary aim is to examine potential mediators of program effectiveness, including treatment engagement and changes in self-efficacy and perceived social support for quitting.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Participants are not explicitly told they are in the control group, although they may deduce their assignment from presence or lack of regular text message intervention.

Research staff doing data collection will not be aware of the random assignments and all participants will receive the same follow-up assessments regardless of assignment.
Primary Purpose: Treatment
Official Title: Text Message Quit Vaping Intervention for Adolescents
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: This is Quitting

Participants will be enrolled to receive messages from This is Quitting.

Users receive one age-appropriate message per day tailored to their enrollment date or quit date, which can be set and reset via text message. Those not ready to quit receive 4 weeks of messages focused on building skills and confidence. Users who set a quit date receive messages for a week preceding it and 8 weeks afterward that include encouragement and support, skill- and self-efficacy building exercises, coping strategies, and information about the risks of vaping, benefits of quitting, and cutting down to quit. Keywords COPE, STRESS, SLIP, and MORE provide on-demand support.

 Behavioral: This is Quitting
Text message-based intervention for quit vaping support.
Assessment only control
After an initial enrollment message, participants will be contacted monthly to assess e-cigarette use. At the end of the study data collection period, they will receive information on how to sign up for This is Quitting if they are interested in the program.
 Other: Assessment only control
Assessment only
No Intervention: Minimal contact control
After an initial enrollment message, participants will not receive any contact except for the data collection for 1 and 7 month follow-up assessments. At the end of the study data collection period, they will receive information on how to sign up for This is Quitting if they are interested in the program.
Outcome Measures
Primary Outcome Measures :
  1. Self-reported 30-day Point Prevalence Abstinence [ Time Frame: 7 months post enrollment ]
    In the past 30 days, did you vape at all, even a puff of someone else's?


Secondary Outcome Measures :
  1. 30-day Point Prevalence Abstinence [ Time Frame: 1 month post enrollment ]
    In the past 30 days, did you vape at all, even a puff of someone else's?

  2. Number of Quit Attempts [ Time Frame: 1 and 7 months post enrollment ]
    Since you joined the study a month ago/In the last 6 months, how many times have you stopped vaping - not even a puff - for one day or longer because you were trying to quit for good?

  3. Changes in Daily E-cigarette Use Frequency [ Time Frame: 1 and 7 months post enrollment ]
    On average, how many puffs/hits on your vape do you take on a typical day?

  4. Changes in Confidence in Quitting E-cigarettes [ Time Frame: 1 and 7 months post enrollment ]
    How confident are you that you can quit vaping? Response on a scale of 1-5


Eligibility Criteria
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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 13-17
  • Past 30-day use of e-cigarettes containing nicotine
  • Interest in quitting e-cigarette use in the next 30 days
  • US residence

Exclusion Criteria:

  • Failure to confirm mobile number after initial sign-up
Contacts and Locations

Contacts
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Contact: Chief of Innovations 202-525-6473 vapestudy@truthinitiative.org

Locations
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United States, District of Columbia
Truth Initiative Recruiting
Washington, District of Columbia, United States, 20001
Sponsors and Collaborators
Truth Initiative
Tracking Information
First Submitted Date  ICMJE June 4, 2021
First Posted Date  ICMJE June 9, 2021
Last Update Posted Date October 25, 2021
Actual Study Start Date  ICMJE October 1, 2021
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2021) 		Self-reported 30-day Point Prevalence Abstinence [ Time Frame: 7 months post enrollment ]
In the past 30 days, did you vape at all, even a puff of someone else's?
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2021)
  • 30-day Point Prevalence Abstinence [ Time Frame: 1 month post enrollment ]
    In the past 30 days, did you vape at all, even a puff of someone else's?
  • Number of Quit Attempts [ Time Frame: 1 and 7 months post enrollment ]
    Since you joined the study a month ago/In the last 6 months, how many times have you stopped vaping - not even a puff - for one day or longer because you were trying to quit for good?
  • Changes in Daily E-cigarette Use Frequency [ Time Frame: 1 and 7 months post enrollment ]
    On average, how many puffs/hits on your vape do you take on a typical day?
  • Changes in Confidence in Quitting E-cigarettes [ Time Frame: 1 and 7 months post enrollment ]
    How confident are you that you can quit vaping? Response on a scale of 1-5
Original Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2021)
  • 30-day Point Prevalence Abstinence [ Time Frame: 1 month post enrollment ]
    In the past 30 days, did you vape at all, even a puff of someone else's?
  • Number of Quit Attempts [ Time Frame: 1 and 7 months post enrollment ]
    Since you joined the study a month ago/In the last 6 months, how many times have you stopped vaping - not even a puff - for one day or longer because you were trying to quit for good?
  • Changes in E-cigarette Use [ Time Frame: 1 and 7 months post enrollment ]
    How many days per week do you vape? On average, how many puffs/hits on your vape do you take on a typical day?
  • Changes in Confidence in Quitting E-cigarettes [ Time Frame: 1 and 7 months post enrollment ]
    How confident are you that you can quit vaping? Response on a scale of 1-5
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Text Message Quit Vaping Intervention for Adolescents
Official Title  ICMJE Text Message Quit Vaping Intervention for Adolescents
Brief Summary This research study, conducted by Truth Initiative, will help us learn how text messaging can help adolescents between 13 and 17 years of age quit vaping.
Detailed Description The Teen Quit Vaping Study (QVS Teen)'s primary aim is to conduct a fully powered comparative effectiveness trial to evaluate the effectiveness of a quit vaping text message program in promoting abstinence from e-cigarettes among young users aged 13-17. This study is a 3-arm randomized controlled trial conducted among young users aged 13-17 recruited through online channels. Participants will be randomized to a quit vaping text message intervention, an assessment-only control condition, and a minimal contact control condition and followed for 7 months to roughly correspond to 6-months post-treatment. The secondary aim is to examine potential mediators of program effectiveness, including treatment engagement and changes in self-efficacy and perceived social support for quitting.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Participants are not explicitly told they are in the control group, although they may deduce their assignment from presence or lack of regular text message intervention.

Research staff doing data collection will not be aware of the random assignments and all participants will receive the same follow-up assessments regardless of assignment.

Primary Purpose: Treatment
Condition  ICMJE
  • Vaping
  • Cessation, Tobacco
Intervention  ICMJE
  • Behavioral: This is Quitting
    Text message-based intervention for quit vaping support.
  • Other: Assessment only control
    Assessment only
Study Arms  ICMJE
  • Experimental: This is Quitting

    Participants will be enrolled to receive messages from This is Quitting.

    Users receive one age-appropriate message per day tailored to their enrollment date or quit date, which can be set and reset via text message. Those not ready to quit receive 4 weeks of messages focused on building skills and confidence. Users who set a quit date receive messages for a week preceding it and 8 weeks afterward that include encouragement and support, skill- and self-efficacy building exercises, coping strategies, and information about the risks of vaping, benefits of quitting, and cutting down to quit. Keywords COPE, STRESS, SLIP, and MORE provide on-demand support.

    Intervention: Behavioral: This is Quitting
  • Assessment only control
    After an initial enrollment message, participants will be contacted monthly to assess e-cigarette use. At the end of the study data collection period, they will receive information on how to sign up for This is Quitting if they are interested in the program.
    Intervention: Other: Assessment only control
  • No Intervention: Minimal contact control
    After an initial enrollment message, participants will not receive any contact except for the data collection for 1 and 7 month follow-up assessments. At the end of the study data collection period, they will receive information on how to sign up for This is Quitting if they are interested in the program.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2021) 		3000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2022
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 13-17
  • Past 30-day use of e-cigarettes containing nicotine
  • Interest in quitting e-cigarette use in the next 30 days
  • US residence

Exclusion Criteria:

  • Failure to confirm mobile number after initial sign-up
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Chief of Innovations 202-525-6473 vapestudy@truthinitiative.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04919590
Other Study ID Numbers  ICMJE TruthInitiativeQVSTeen
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: IPD are not available to other researchers. For access to deidentified dataset, please contact study administrator for more information.
Responsible Party Truth Initiative
Study Sponsor  ICMJE Truth Initiative
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Truth Initiative
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP