Behavior, HealthNCT04467034
Evaluation of The Stanford Tobacco Prevention Toolkit
A study testing Stanford Tobacco Prevention Toolkit curriculum in people with Behavior, Health and Behavior, Smoking, run by Stanford University at 1 site in United States.
Trial summary
The Stanford Tobacco Prevention Toolkit is a free online curriculum developed for use by educators and health professionals in providing tobacco-specific prevention education to middle and high school students. Read more about this study
- Who is it for?
- Ages 11 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Health, Behavior, Smoking
- What is being tested?
- Stanford Tobacco Prevention Toolkit curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Middle school and high school students
Who cannot join
- Non English-speakers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial to Evaluate The Stanford Tobacco Prevention Toolkit
The Stanford Tobacco Prevention Toolkit is a free online curriculum developed for use by educators and health professionals in providing tobacco-specific prevention education to middle and high school students. The aims of this study are to determine: (1) whether the Curriculum is effective in changing middle and high school students' resistance to using tobacco as well as knowledge of, attitudes towards, and intentions to use different tobacco products; and (2) whether the Curriculum is effective in changing middle and high school students' actual use of tobacco in the short-term.
- Conditions
- Behavior, Health, Behavior, Smoking
- Being tested
- Stanford Tobacco Prevention Toolkit curriculum
- Keywords
- children, young adults, tobacco, education, health, smoking, prevention
- Medical subject headings
- Health Behavior, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stanford Tobacco Prevention Toolkit curriculumBehavioural
Stanford Toolkit curriculum delivered as a 5-session course in a school classroom setting.
| Study group | Role | What they receive |
|---|---|---|
| Receives Stanford tobacco education curriculum | Experimental | Stanford Tobacco Prevention Toolkit is administered. Receives: Behavioral: Stanford Tobacco Prevention Toolkit curriculum |
| Does not receive Stanford tobacco education curriculum | No intervention | Receives another curriculum or no tobacco education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in resistance to use of tobacco products scaled score as measured by investigator-originated survey
This survey measures change in resistance to use of tobacco products with questions related to the participant's intention to use tobacco.
Measured: Change from baseline to follow-up at approximately 40 weeks post-baseline
Secondary outcomes (3)
Change in skills for refusal of tobacco products scaled score as measured by investigator-originated survey
This survey measures change in skills to refuse tobacco use with questions related to the participant's susceptibility to tobacco use, self-efficacy and self-confidence.
Measured: Change from baseline to follow-up at approximately 40 weeks post-baseline
Change in knowledge of tobacco products scaled score as measured by investigator-originated survey
This survey measures knowledge of tobacco products with questions related to the participant's knowledge of ingredients, of nicotine levels, of potential health outcomes.
Measured: Change from baseline to follow-up at approximately 40 weeks post-baseline
This survey measures use of tobacco products with questions related to the participant's ever tobacco use, past 30-day tobacco use, and past 7-day tobacco use.
Investigator-originated survey survey measures (questions) assess ever tobacco use, past 30-day tobacco use, past 7-day tobacco use This outcome measure assesses tobacco products use.
Measured: Change from baseline to follow-up at approximately 40 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start15 Oct 2021 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion31 May 2022 (estimated)
Why it stopped: Schools were unable to participate due the COVID-19 pandemic, which shifted educational priorities and therefore impeded school-based recruiting efforts. No participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, HealthStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Responsible party
- Principal investigator, Bonnie Halpern-Felsher, Stanford University
- Investigators
- Bonnie L Halpern-Felsher, Principal investigator, Stanford School of Medicine, Department of PediatricsMichael Baiocchi, Principal investigator, Stanford School of Medicine, Department of Epidemiology and Population Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467034
- Sponsor's protocol ID
- 54817
- Status last verified
- Aug 2022
- First submitted
- 21 May 2020
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Evaluate The Stanford Tobacco Prevention Toolkit
- ClinicalTrials.gov ID
- NCT04467034
- Acronym / sponsor ID
- 54817
- Conditions
- Behavior, Health, Behavior, Smoking
- Keywords
- children, young adults, tobacco, education, health, smoking, prevention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Schools were unable to participate due the COVID-19 pandemic, which shifted educational priorities and therefore impeded school-based recruiting efforts. No participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Tobacco Related Disease Research Program
- Study start
- 15 Oct 2021 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Stanford Tobacco Prevention Toolkit is a free online curriculum developed for use by educators and health professionals in providing tobacco-specific prevention education to middle and high school students. The aims of this study are to determine: (1) whether the Curriculum is effective in changing middle and high school students' resistance to using tobacco as well as knowledge of, attitudes towards, and intentions to use different tobacco products; and (2) whether the Curriculum is effective in changing middle and high school students' actual use of tobacco in the short-term.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receives Stanford tobacco education curriculum | Experimental | Behavioral: Stanford Tobacco Prevention Toolkit curriculumStanford Tobacco Prevention Toolkit is administered. |
| Does not receive Stanford tobacco education curriculum | No intervention | –Receives another curriculum or no tobacco education. |
Who may qualify
- Ages
- 11 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Middle school and high school students
Key exclusion criteria (1 listed)
- Non English-speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stanford Tobacco Prevention Toolkit curriculumStanford Toolkit curriculum delivered as a 5-session course in a school classroom setting. | Behavioural | Receives Stanford tobacco education curriculum |
Primary outcome
Change in resistance to use of tobacco products scaled score as measured by investigator-originated survey
Time frame: Change from baseline to follow-up at approximately 40 weeks post-baseline
This survey measures change in resistance to use of tobacco products with questions related to the participant's intention to use tobacco.
3 secondary outcomes
Change in skills for refusal of tobacco products scaled score as measured by investigator-originated survey
Time frame: Change from baseline to follow-up at approximately 40 weeks post-baseline
Change in knowledge of tobacco products scaled score as measured by investigator-originated survey
Time frame: Change from baseline to follow-up at approximately 40 weeks post-baseline
This survey measures use of tobacco products with questions related to the participant's ever tobacco use, past 30-day tobacco use, and past 7-day tobacco use.
Time frame: Change from baseline to follow-up at approximately 40 weeks post-baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Stanford Tobacco Prevention ToolkitLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonnie L Halpern-Felsher principal investigator
Stanford School of Medicine, Department of Pediatrics
Michael Baiocchi principal investigator
Stanford School of Medicine, Department of Epidemiology and Population Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stanford Tobacco Prevention Toolkit curriculum in people with Behavior, Health and Behavior, Smoking, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in resistance to use of tobacco products scaled score as measured by investigator-originated survey (time frame: Change from baseline to follow-up at approximately 40 weeks post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.