Evaluation of The Stanford Tobacco Prevention Toolkit

August 19, 2022 updated by: Bonnie Halpern-Felsher, Stanford University

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • 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 Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University

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

Ages Eligible for Study

11 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Middle school and high school students

Exclusion Criteria:

  • Non English-speakers

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Receives Stanford tobacco education curriculum
Stanford Tobacco Prevention Toolkit is administered.
Behavioral: Stanford Tobacco Prevention Toolkit curriculum
Stanford Toolkit curriculum delivered as a 5-session course in a school classroom setting.
No Intervention: Does not receive Stanford tobacco education curriculum
Receives another curriculum or no tobacco education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to follow-up at approximately 40 weeks post-baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
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 knowledge of tobacco products with questions related to the participant's knowledge of ingredients, of nicotine levels, of potential health outcomes.
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
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.
Change from baseline to follow-up at approximately 40 weeks post-baseline

Collaborators and Investigators

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

Sponsor

Stanford University

Collaborators

Tobacco Related Disease Research Program

Investigators

  • Principal Investigator: Bonnie L Halpern-Felsher, Stanford School of Medicine, Department of Pediatrics
  • Principal Investigator: Michael Baiocchi, Stanford School of Medicine, Department of Epidemiology and Population Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Anticipated)

October 15, 2021

Primary Completion (Anticipated)

April 30, 2022

Study Completion (Anticipated)

May 31, 2022

Study Registration Dates

First Submitted

May 21, 2020

First Submitted That Met QC Criteria

July 7, 2020

First Posted (Actual)

July 10, 2020

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 54817

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.

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