NCT04467034

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
1.3 years until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

7 months

First QC Date

May 21, 2020

Last Update Submit

August 19, 2022

Conditions

Keywords

childrenyoung adultstobaccoeducationhealthsmokingprevention

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    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.

    Change from baseline to follow-up at approximately 40 weeks post-baseline

Study Arms (2)

Receives Stanford tobacco education curriculum

EXPERIMENTAL

Stanford Tobacco Prevention Toolkit is administered.

Behavioral: Stanford Tobacco Prevention Toolkit curriculum

Does not receive Stanford tobacco education curriculum

NO INTERVENTION

Receives another curriculum or no tobacco education.

Interventions

Stanford Toolkit curriculum delivered as a 5-session course in a school classroom setting.

Receives Stanford tobacco education curriculum

Eligibility Criteria

Age11 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Middle school and high school students

You may not qualify if:

  • Non English-speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Related Links

MeSH Terms

Conditions

Health BehaviorSmoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

May 21, 2020

First Posted

July 10, 2020

Study Start

October 15, 2021

Primary Completion

April 30, 2022

Study Completion

May 31, 2022

Last Updated

August 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations