Social Media Intervention to Stop Nicotine and Cannabis Vaping Among Adolescents

June 18, 2024 updated by: University of California, San Francisco
Social media based intervention to support teens in their efforts to quit vaping.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a randomized controlled trial of a social media intervention to support teens in their efforts to quit vaping.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. English literacy
  2. Age between 13-21 years
  3. Indicate they use social media "most" (>= 4) days per week
  4. Have vaped at least once per week in the past 30 days (90 percent of participants)
  5. Access to a computer or mobile phone with photo capability to verify abstinence from vaping
  6. Indicate they are considering quitting or are interested in quitting with the next 6 months or within the next 30 days
  7. Currently reside in California

Exclusion Criteria:

  1. No English literacy
  2. Age under 13 or over 21
  3. Insufficient social media use (3 or fewer days per week)
  4. Have not vaped at least once per week in past 30 days
  5. No access to computer or mobile phone with photo capability to verify abstinence from vaping
  6. Not considering or interested in quitting vaping in the next 30 days or 6 months;
  7. Not a California resident

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Vaping Intervention
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.
Behavioral: Social Media Intervention
Social media based intervention using Instagram with up to 3 posts per day for 30 days
No Intervention: Control Condition
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Point Prevalent Abstinence (PPA) from vaping
Time Frame: 1 month
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.
1 month
Point Prevalent Abstinence (PPA) from vaping
Time Frame: 3 months
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.
3 months
Point Prevalent Abstinence (PPA) from vaping
Time Frame: 6 months
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the number of participants with reduction in vaping
Time Frame: Up to 6 months
Reduction in vaping is defined as a decline in vaping frequency by 50 percent (%) or more.
Up to 6 months
Change in the number of vape quit attempts
Time Frame: Up to 6 months
The number of quit attempts will be recorded at each assessment.
Up to 6 months
Number of participants with at least 1 quit attempt
Time Frame: Up to 6 months
The number of participants whom achieved at least one quit attempt during the full assessment time period will be reported.
Up to 6 months
Change in response on Stages of Change Questionnaire
Time Frame: Up to 6 months
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'.
Up to 6 months
Change in the score on the Thoughts About Abstinence (TAA) Questionnaire
Time Frame: Up to 6 months
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)
Up to 6 months
Change in the scores on the Ways of Quitting questionnaire (WOQ)
Time Frame: Up to 6 months
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).
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
HopeLab Foundation
Tobacco Related Disease Research Program
Rescue Agency

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pamela Ling, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • T31IR1910 (Other Grant/Funding Number: Tobacco Related Diseases Research Program)
  • 21633 (Other Identifier: University of California, San Francisco)
  • NCI-2021-11423 (Registry Identifier: NCI Clinical Trials Reporting Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings