Evaluation of The Stanford Tobacco Prevention Toolkit

Sponsor

Stanford University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04467034

Collaborator

Tobacco Related Disease Research Program (Other)

Enrollment

Location

Arms

7.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Behavior, Health Behavior, Smoking	Behavioral: Stanford Tobacco Prevention Toolkit curriculum	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

A Randomized Controlled Trial to Evaluate The Stanford Tobacco Prevention Toolkit

Anticipated Study Start Date :

Oct 15, 2021

Anticipated Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

May 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in resistance to use of tobacco products scaled score as measured by investigator-originated survey [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.

Secondary Outcome Measures

Change in skills for refusal of tobacco products scaled score as measured by investigator-originated survey [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 in knowledge of tobacco products scaled score as measured by investigator-originated survey [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.
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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Middle school and high school students

Exclusion Criteria:

Non English-speakers

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94304

Sponsors and Collaborators

Stanford University
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