Back to resultsSocial Media Intervention to Stop Nicotine and Cannabis Vaping Among Adolescents
Primary Purpose
Vaping
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Media Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Vaping focused on measuring Nicotine Dependence, Social Media
Eligibility Criteria
Inclusion Criteria:
- English literacy
- Age between 13-17 years
- Indicate they use social media "most" (>= 4) days per week
- Have vaped at least once per week in the past 30 days (90 percent of participants)
- Access to a computer or mobile phone with photo capability to verify abstinence from vaping
- Indicate they are considering quitting or are interested in quitting with the next 6 months or within the next 30 days
- Currently reside in California
Exclusion Criteria:
- No English literacy
- Age under 13 or over 17
- Insufficient social media use (3 or fewer days per week)
- Have not vaped at least once per week in past 30 days
- No access to computer or mobile phone with photo capability to verify abstinence from vaping
- Not considering or interested in quitting vaping in the next 30 days or 6 months;
- Not a California resident
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Vaping Intervention
Control Condition
Arm Description
The vaping intervention will be implemented on Instagram. Participants in the treatment condition will be assigned to groups on Instagram, where they will receive up to 3 posts per day for 30 days. Groups are facilitated by a trained Guide, working with the Principal Investigator, Co-Investigators and a Pediatrician on demand if additional expertise or clinical advice is needed. Participants will be educated about signs of nicotine dependence and if they express interest in pharmacotherapy will be encouraged to access this through their personal healthcare providers. The Instagram groups will provide educational and social support, troubleshooting and advice about nicotine replacement therapy (NRT) or other forms of treatment.
Participants in the control condition will be directed to the Truth Initiative e-cigarette texting quit program. This innovative and free text message program was created with input from teens, college students and young adults who have attempted to, or successfully, quit e-cigarettes using text coaching methods
Outcomes
Primary Outcome Measures
Point Prevalent Abstinence (PPA) from vaping
7-day point prevalence abstinence (PPA) from all tobacco products will be assessed over the course of the study. Participants reporting no vaping in the past 7 days will be coded as abstinent. Those reporting 7-day abstinence and not using nicotine replacement therapy will be mailed saliva cotinine test kit and saliva tetrahydrocannabinol (THC) test kit for biochemical verification of abstinence.
Point Prevalent Abstinence (PPA) from vaping
7-day point prevalence abstinence (PPA) from all tobacco products will be assessed over the course of the study. Participants reporting no vaping in the past 7 days will be coded as abstinent. Those reporting 7-day abstinence and not using nicotine replacement therapy will be mailed saliva cotinine test kit and saliva tetrahydrocannabinol (THC) test kit for biochemical verification of abstinence.
Point Prevalent Abstinence (PPA) from vaping
7-day point prevalence abstinence (PPA) from all tobacco products will be assessed over the course of the study. Participants reporting no vaping in the past 7 days will be coded as abstinent. Those reporting 7-day abstinence and not using nicotine replacement therapy will be mailed saliva cotinine test kit and saliva tetrahydrocannabinol (THC) test kit for biochemical verification of abstinence.
Secondary Outcome Measures
Change in the number of participants with reduction in vaping
Reduction in vaping is defined as a decline in vaping frequency by 50 percent (%) or more.
Change in the number of vape quit attempts
The number of quit attempts will be recorded at each assessment.
Number of participants with at least 1 quit attempt
The number of participants whom achieved at least one quit attempt during the full assessment time period will be reported.
Change in response on Stages of Change Questionnaire
The participants readiness to quit will be measured using the Stages of Change questionnaire - single item, which asks "Are you seriously thinking of quitting smoking?" Answers range from 'Yes, within the next 30 days', 'Yes, within the next 6 months', and 'No, not thinking of quitting'.
Change in the score on the Thoughts About Abstinence (TAA) Questionnaire
The adapted Thoughts About Abstinence Questionnaire (Hall et al., 1991) is a 3 item self-report questionnaire that measures: 1) desire to quit smoking, 2) expected success at quitting, 3) expected difficulty of quitting on 10-point Likert scales (e.g., 1=no desire to quit/lowest expectation/lowest level of difficulty to 10 = extreme desire to quit/highest expectation of success/highest expected difficulty)
Change in the scores on the Ways of Quitting questionnaire (WOQ)
The WOQ is a 28-item self-report instrument assessing adolescent smoking cessation strategies. For each WOQ item, respondents indicate whether they have used a given strategy (yes/no) and, if used, how helpful it was perceived to be on a five-point Likert-type scale (1= "Not helpful" to 5="Extremely helpful") with regard to several categories: Social support, Seeking assistance, Avoidance, Reduction, Substitution, Medication, Distraction, and Quit all at once (single item).
Full Information
NCT ID
NCT04707911
First Posted
January 11, 2021
Last Updated
June 1, 2023
Sponsor
University of California, San Francisco
Collaborators
Tobacco Related Disease Research Program, HopeLab Foundation, Rescue Agency
1. Study Identification
Unique Protocol Identification Number
NCT04707911
Brief Title
Social Media Intervention to Stop Nicotine and Cannabis Vaping Among Adolescents
Official Title
Social Media Intervention to Stop Nicotine and Cannabis Vaping Among Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 18, 2021 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Tobacco Related Disease Research Program, HopeLab Foundation, Rescue Agency
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Social media based intervention to support teens in their efforts to quit vaping.
Detailed Description
This study is a randomized controlled trial of a social media intervention to support teens in their efforts to quit vaping.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaping
Keywords
Nicotine Dependence, Social Media
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaping Intervention
Arm Type
Experimental
Arm Description
The vaping intervention will be implemented on Instagram. Participants in the treatment condition will be assigned to groups on Instagram, where they will receive up to 3 posts per day for 30 days. Groups are facilitated by a trained Guide, working with the Principal Investigator, Co-Investigators and a Pediatrician on demand if additional expertise or clinical advice is needed. Participants will be educated about signs of nicotine dependence and if they express interest in pharmacotherapy will be encouraged to access this through their personal healthcare providers. The Instagram groups will provide educational and social support, troubleshooting and advice about nicotine replacement therapy (NRT) or other forms of treatment.
Arm Title
Control Condition
Arm Type
No Intervention
Arm Description
Participants in the control condition will be directed to the Truth Initiative e-cigarette texting quit program. This innovative and free text message program was created with input from teens, college students and young adults who have attempted to, or successfully, quit e-cigarettes using text coaching methods
Intervention Type
Behavioral
Intervention Name(s)
Social Media Intervention
Intervention Description
Social media based intervention using Instagram with up to 3 posts per day for 30 days
Primary Outcome Measure Information:
Title
Point Prevalent Abstinence (PPA) from vaping
Description
7-day point prevalence abstinence (PPA) from all tobacco products will be assessed over the course of the study. Participants reporting no vaping in the past 7 days will be coded as abstinent. Those reporting 7-day abstinence and not using nicotine replacement therapy will be mailed saliva cotinine test kit and saliva tetrahydrocannabinol (THC) test kit for biochemical verification of abstinence.
Time Frame
1 month
Title
Point Prevalent Abstinence (PPA) from vaping
Description
7-day point prevalence abstinence (PPA) from all tobacco products will be assessed over the course of the study. Participants reporting no vaping in the past 7 days will be coded as abstinent. Those reporting 7-day abstinence and not using nicotine replacement therapy will be mailed saliva cotinine test kit and saliva tetrahydrocannabinol (THC) test kit for biochemical verification of abstinence.
Time Frame
3 months
Title
Point Prevalent Abstinence (PPA) from vaping
Description
7-day point prevalence abstinence (PPA) from all tobacco products will be assessed over the course of the study. Participants reporting no vaping in the past 7 days will be coded as abstinent. Those reporting 7-day abstinence and not using nicotine replacement therapy will be mailed saliva cotinine test kit and saliva tetrahydrocannabinol (THC) test kit for biochemical verification of abstinence.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in the number of participants with reduction in vaping
Description
Reduction in vaping is defined as a decline in vaping frequency by 50 percent (%) or more.
Time Frame
Up to 6 months
Title
Change in the number of vape quit attempts
Description
The number of quit attempts will be recorded at each assessment.
Time Frame
Up to 6 months
Title
Number of participants with at least 1 quit attempt
Description
The number of participants whom achieved at least one quit attempt during the full assessment time period will be reported.
Time Frame
Up to 6 months
Title
Change in response on Stages of Change Questionnaire
Description
The participants readiness to quit will be measured using the Stages of Change questionnaire - single item, which asks "Are you seriously thinking of quitting smoking?" Answers range from 'Yes, within the next 30 days', 'Yes, within the next 6 months', and 'No, not thinking of quitting'.
Time Frame
Up to 6 months
Title
Change in the score on the Thoughts About Abstinence (TAA) Questionnaire
Description
The adapted Thoughts About Abstinence Questionnaire (Hall et al., 1991) is a 3 item self-report questionnaire that measures: 1) desire to quit smoking, 2) expected success at quitting, 3) expected difficulty of quitting on 10-point Likert scales (e.g., 1=no desire to quit/lowest expectation/lowest level of difficulty to 10 = extreme desire to quit/highest expectation of success/highest expected difficulty)
Time Frame
Up to 6 months
Title
Change in the scores on the Ways of Quitting questionnaire (WOQ)
Description
The WOQ is a 28-item self-report instrument assessing adolescent smoking cessation strategies. For each WOQ item, respondents indicate whether they have used a given strategy (yes/no) and, if used, how helpful it was perceived to be on a five-point Likert-type scale (1= "Not helpful" to 5="Extremely helpful") with regard to several categories: Social support, Seeking assistance, Avoidance, Reduction, Substitution, Medication, Distraction, and Quit all at once (single item).
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
English literacy
Age between 13-21 years
Indicate they use social media "most" (>= 4) days per week
Have vaped at least once per week in the past 30 days (90 percent of participants)
Access to a computer or mobile phone with photo capability to verify abstinence from vaping
Indicate they are considering quitting or are interested in quitting with the next 6 months or within the next 30 days
Currently reside in California
Exclusion Criteria:
No English literacy
Age under 13 or over 21
Insufficient social media use (3 or fewer days per week)
Have not vaped at least once per week in past 30 days
No access to computer or mobile phone with photo capability to verify abstinence from vaping
Not considering or interested in quitting vaping in the next 30 days or 6 months;
Not a California resident
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Ling, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Social Media Intervention to Stop Nicotine and Cannabis Vaping Among Adolescents
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