Online Program for Quitting Smoking

Overseen By Divya Ramamurthi

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Non-English speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an online program, Healthy Futures: Alternative-to-Suspension Curriculum, can help high school students quit using tobacco or nicotine products. Participants include students who currently use these products or want to quit. Schools will either implement this program immediately or continue with their usual methods for a period before switching to the program. High school students who have used tobacco or nicotine and want to stop are well-suited for this trial. As an unphased trial, this study offers students the opportunity to participate in innovative research that could assist them in quitting tobacco or nicotine products.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on quitting tobacco and nicotine use.

What prior data suggests that this program is safe for students?

Research has shown that the Healthy Futures: Alternative-to-Suspension Curriculum is a safe and well-received educational program. This online course helps students quit using tobacco and nicotine products. It employs techniques like motivational interviewing and cognitive behavioral therapy, which have proven safe and effective in encouraging positive behavioral changes.

No reports of problems or safety issues have emerged with this program, as it serves as an educational tool rather than a medical treatment. The course is self-paced and includes interactive materials, providing a flexible and engaging resource for students. It offers a supportive environment without any risk of physical harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Healthy Futures: Alternative-to-Suspension Curriculum because it offers a unique approach to helping students quit smoking. Unlike traditional methods that might focus on punishment or standard counseling, this program integrates educational content directly into school settings, providing an alternative to suspension for students caught using tobacco. By embedding the program in schools, it can reach students in a supportive environment, promoting a healthier lifestyle while keeping them engaged in their education. The program's long-term engagement, lasting three years, also allows for sustained support, which is crucial for lasting behavior change.

What evidence suggests that the Healthy Futures: Alternative-to-Suspension Curriculum is effective for quitting smoking?

Research has shown that the Healthy Futures: Alternative-to-Suspension Curriculum, a treatment option in this trial, can help students stop using tobacco and nicotine. This online program employs methods such as motivational interviewing and cognitive behavioral therapy (CBT) to support students. Studies have found that similar programs can improve students' understanding and attitudes about tobacco use. Early results suggest that students who participate in this curriculum often reduce or quit tobacco use. By offering resources and education, Healthy Futures provides a supportive way for students to change their habits without the negative effects of suspension. ^{1 2 3 6 7}

Who Is on the Research Team?

Bonnie Halpern-Felsher, Ph.D

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for high school students who are currently using tobacco or nicotine products and may be interested in quitting. There's no specific exclusion criteria provided, so it seems open to any student willing to participate.

Inclusion Criteria

I am between 14-18 years old and agree to join the study.

I agree to possibly use a new care approach instead of the standard one.

Agree that teachers, counselors, or other school personnel will schedule an online survey prior to and after implementation of Healthy Futures: Alternative-to-Suspension or current standard of care with students caught using e-cigarettes or other tobacco products and with students self-reporting use of those products and seeking help to quit

Exclusion Criteria

I am a teenager aged 14-18 and do not speak English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Students receive the Healthy Futures: Alternative-to-Suspension Curriculum

3 years

Ongoing online curriculum

Follow-up

Participants are monitored for changes in tobacco/nicotine use and intentions

2.5 years

Surveys at baseline, 1 year, 1.5 years, 2 years, and 2.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Futures: Alternative-to-Suspension Curriculum

Trial Overview The trial is testing the 'Healthy Futures: Alternative-to-Suspension' online curriculum designed to educate students about tobacco/nicotine use and help them quit. It measures changes in their knowledge, attitudes, intentions, and actual usage of these substances.

How Is the Trial Designed?

Group I: Stanford REACH Lab Healthy Futures Curriculum Experimental Treatment 1 Intervention

At the start of Year 1, schools will be randomized in a 1:1 ratio to either receive 'Stanford REACH Lab's Healthy Futures: Alternative-to-Suspension Curriculum' or 'delay-in-treatment (standard of care)'. Students in these schools who are found using tobacco/nicotine or who want to quit these products will be administered the Healthy Futures: Alternative-to-Suspension curriculum for 3 years.

Group II: Delay In Treatment Experimental Treatment 1 Intervention

At the start of Year 1, schools will be randomized in a 1:1 ratio to either receive 'Stanford REACH Lab's Healthy Futures: Alternative-to-Suspension Curriculum' or 'delay-in-treatment (standard of care).' Schools in this arm will receive a standard of care for one year. After year 1, the delay-in-treatment group will crossover to receive 'Stanford REACH Lab's Healthy Futures: Alternative-to-Suspension Curriculum until year 3 (receive intervention for years 2 and 3).

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

California School-Based Health Alliance

Collaborator

Trials

2

Recruited

3,100+

Published Research Related to This Trial

The Fax-to-Quit program in West Virginia successfully engaged pregnant smokers by connecting them with cessation services, with 25.9% of referred women enrolling in Quitline services, indicating a feasible approach to support smoking cessation during pregnancy.

The program highlights the importance of provider involvement and communication in facilitating referrals, suggesting that structured support can enhance access to quitting resources for pregnant women who smoke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Encouraging smoking cessation during pregnancy in West Virginia: using Fax-to-Quit as a cessation strategy. Tworek, C., Horn, KA., Anderson, RH., et al.[2013]

A train-the-trainer program for respiratory therapy faculty significantly improved their confidence and ability to teach tobacco cessation, with 97.4% of participants finding the training format effective for learning.

The initiative reached 270 faculty members from 248 respiratory therapy schools, leading to an anticipated median of 3 hours of tobacco cessation training for 1,248 students in the following academic year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an Interprofessional Tobacco Cessation Train-the-Trainer Program for Respiratory Therapy Faculty. Hudmon, KS., Vitale, FM., Elkhadragy, N., et al.[2023]

Citations

1. schoolhealthcenters.org schoolhealthcenters.org/wp-content/uploads/2023/11/Healthy-Futures_Effective-Alternatives-to-Suspension-11-1-23.pdf

Healthy Futures: Effective Alternatives to Suspension for ... Healthy Futures is a self-paced course for students using e-cigarettes, tobacco, or cannabis, using motivational interviewing and CBT, as an alternative to ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06483412

An Evaluation of the Tobacco Prevention Toolkit Healthy ... The Healthy Futures: Alternative-to-Suspension Curriculum is a free, online curriculum developed to educate students and provide them with resources to quit ...

3. med.stanford.edu med.stanford.edu/tobaccopreventiontoolkit/healthy-futures-nicotine.html

Healthy Futures Nicotine | Tobacco Prevention Toolkit Healthy Futures is an alternative-to-suspension program for students using tobacco, with self-paced and teacher-led curriculum, and quitting resources.

4. health.state.mn.us health.state.mn.us/communities/tobacco/ecigarettes/schools/suspension.html

Why Schools Should Implement Alternatives to Suspension ... Suspensions are harmful, linked to mental health issues, negative outcomes, and lower test scores. Alternatives can improve outcomes and ...

5. ctv.veeva.com ctv.veeva.com/study/an-evaluation-of-the-tobacco-prevention-toolkit-healthy-futures-alternative-to-suspension-vaping-in

An Evaluation of the Tobacco Prevention Toolkit Healthy Futures The investigation aims to estimate the extent to which Healthy Futures: Alternative-to-Suspension changes high school student's knowledge of, ...

6. www2.heart.org www2.heart.org/site/DocServer/AHA_Tobacco-Free_Schools_Toolkit.pdf

TOBACCO-FREE SCHOOLS TOOLKIT b. Healthy Futures: An Alternative-to-Suspension offers a flexible 1-, 2- or 4-hour online curriculum with activities and interactive materials.

7. med.stanford.edu med.stanford.edu/tobaccopreventiontoolkit/healthy-futures-nicotine/my-healthy-futures-nicotine.html

MY Healthy Futures - Nicotine | Tobacco Prevention Toolkit An Alternative-to-Suspension curriculum geared for students who have been caught using nicotine products, e-cigarettes, or any tobacco products.