Focus of the Study is Smoking Cessation and PreventionNCT07895784
Effectiveness Of Project EX: A Classroom-Based Smoking Prevention And Cessation Intervention Program
A study testing Project EX in people with Focus of the Study is Smoking Cessation and Prevention and Smoking Prevention, run by University of Karachi at 1 site in Pakistan.
Trial summary
The goal of this intervention is to learn if Project EX helps in prevention and cessation of smoking in adolescents. The main question it aims to answer is: 1. To evaluate whether students in the Project EX Intervention Group would demonstrate immediate, post and six-month effects as compared to Standard Care Control… Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus of the Study is Smoking Cessation and Prevention, Smoking Prevention
- What is being tested?
- Project EX
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Nov 2026to 28 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
The sample selection will be done using following inclusion/ exclusion criteria:
- Only those public and private schools will be included who will give consent for implementation of Project Ex.
- At the time of the selection process, schools with an active, on-going health education programe with tobacco control as a key component would be excluded.
- Only those adolescents will be included whose families will give consent to participate in study.
- Adolescents with an age range of 14 years to 18 years would be included.
- Adolescent who currently smoke and those who are non-smokers would both be included.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this intervention is to learn if Project EX helps in prevention and cessation of smoking in adolescents. The main question it aims to answer is:
- To evaluate whether students in the Project EX Intervention Group would demonstrate immediate, post and six-month effects as compared to Standard Care Control Group
Researchers will compare Intervention Group with compared to Standard Care Control Group to see the effect of intervention.
Participants will receive the intervention Fill pre, post and 6 month follow-up forms.
- Being tested
- Project EX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project EXBehavioural
Project EX consists of 8 sessions, each 40-45 minutes in length. The lessons are designed to be delivered over a 6 week period. Generally two sessions are provided per week for two weeks, followed by one session per week for the subsequent 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Intervention Group will receive the intervention which is Project EX Receives: Behavioral: Project EX |
| Standard care control | No intervention | Standard care control Group will not receive the intervention which is Project EX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Mean motivation to quit tobacco use Score .
Measured with self-report items on the likelihood of motivation to quit in the future. Lower scores indicate greater motivation to quit.
Measured: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Change from Baseline in Mean Smoking Intention Score.
Measured with self-report items on the likelihood of smoking in the future. Lower scores indicate greater intention to smoke.
Measured: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Change from Baseline in Mean Tobacco norm attitude Score
Scale assessing perceived acceptability of tobacco use among peers. Lower scores indicate more favorable attitudes toward tobacco use.
Measured: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Change from Baseline in Mean Self control Score
Scale assessing self control items. Higher scores indicate greater self-control.
Measured: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Change from Baseline in Mean depression Score
Measured with the Center for Epidemiologic Studies Depression Scale (CES-D). Higher scores indicate more depressive symptoms.
Measured: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Change from Baseline in Smoking-Related Knowledge
Measured the health consequences of smoking. Higher scores indicate greater knowledge.
Measured: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Change from Baseline in Endorsement of Tobacco Use Myths
Measured on common misconceptions about tobacco use.
Measured: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Change from Baseline in Tobacco Use Behavior
Measured with self-report items on frequency and amount of tobacco use (cigarettes and other tobacco products) in the past 30 days. Higher scores indicate greater tobacco use.
Measured: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Change from Baseline in Quit Attempts
Measured with self-report items on whether, and how many times, students who use tobacco tried to quit since the previous assessment.
Measured: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Change from Baseline in Coping
Measured with items assessing ways of coping with stress and difficult situations without tobacco use. This scale's items are divided into good coping and bad coping
Measured: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Change from Baseline in Sense of Coherence
Measured with self reported scale assessing the extent to which students see life as comprehensible, manageable, and meaningful.
Measured: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Change from Baseline in Exposure to Tobacco-Related Programming and Tobacco Advertising
Measured with self-report items on exposure to anti-tobacco programs or messages and to pro-tobacco advertisements or promotions. Higher scores indicate greater exposure.
Measured: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start10 Nov 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion28 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus of the Study is Smoking Cessation and PreventionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The Quasi Experimental Pretest-Posttest Non-Equivalent Control Group (between-subject design).
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naseem Akhtar, University of Karachi
- Investigators
- Naseem Akhtar, PhD Scholar, Principal investigator, Institute of clinical psychology, University of Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895784
- Sponsor's protocol ID
- ICP-1(101)/7885
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding the sharing of IPD has not yet been made. This will be determined in consultation with the supervisor and will depend on participant consent and the ability to adequately de-identify the data.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Project EX: A Classroom-Based Smoking Prevention And Cessation Intervention Program
- ClinicalTrials.gov ID
- NCT07895784
- Acronym / sponsor ID
- ICP-1(101)/7885
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 28 May 2027 (estimated)
- First posted
- 26 Oct 2026 (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 goal of this intervention is to learn if Project EX helps in prevention and cessation of smoking in adolescents. The main question it aims to answer is:
- To evaluate whether students in the Project EX Intervention Group would demonstrate immediate, post and six-month effects as compared to Standard Care Control Group
Researchers will compare Intervention Group with compared to Standard Care Control Group to see the effect of intervention.
Participants will receive the intervention Fill pre, post and 6 month follow-up forms.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Quasi Experimental Pretest-Posttest Non-Equivalent Control Group (between-subject design).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Project EXIntervention Group will receive the intervention which is Project EX |
| Standard care control | No intervention | –Standard care control Group will not receive the intervention which is Project EX |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Project EXProject EX consists of 8 sessions, each 40-45 minutes in length. The lessons are designed to be delivered over a 6 week period. Generally two sessions are provided per week for two weeks, followed by one session per week for the subsequent 4 weeks. | Behavioural | Intervention Group |
Primary outcome
Change from Baseline in Mean motivation to quit tobacco use Score .
Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Measured with self-report items on the likelihood of motivation to quit in the future. Lower scores indicate greater motivation to quit.
Change from Baseline in Mean Smoking Intention Score.
Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Measured with self-report items on the likelihood of smoking in the future. Lower scores indicate greater intention to smoke.
Change from Baseline in Mean Tobacco norm attitude Score
Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Scale assessing perceived acceptability of tobacco use among peers. Lower scores indicate more favorable attitudes toward tobacco use.
Change from Baseline in Mean Self control Score
Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Scale assessing self control items. Higher scores indicate greater self-control.
Change from Baseline in Mean depression Score
Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Measured with the Center for Epidemiologic Studies Depression Scale (CES-D). Higher scores indicate more depressive symptoms.
Change from Baseline in Smoking-Related Knowledge
Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Measured the health consequences of smoking. Higher scores indicate greater knowledge.
Change from Baseline in Endorsement of Tobacco Use Myths
Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Measured on common misconceptions about tobacco use.
Change from Baseline in Tobacco Use Behavior
Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Measured with self-report items on frequency and amount of tobacco use (cigarettes and other tobacco products) in the past 30 days. Higher scores indicate greater tobacco use.
Change from Baseline in Quit Attempts
Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Measured with self-report items on whether, and how many times, students who use tobacco tried to quit since the previous assessment.
Change from Baseline in Coping
Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Measured with items assessing ways of coping with stress and difficult situations without tobacco use. This scale's items are divided into good coping and bad coping
Change from Baseline in Sense of Coherence
Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Measured with self reported scale assessing the extent to which students see life as comprehensible, manageable, and meaningful.
Change from Baseline in Exposure to Tobacco-Related Programming and Tobacco Advertising
Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)
Measured with self-report items on exposure to anti-tobacco programs or messages and to pro-tobacco advertisements or promotions. Higher scores indicate greater exposure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Sussman, S., Miyano, J., Rohrbach, L. A., Dent, C. W., \& Sun, P. (2007). Six-month and one-year effects of Project EX-4: A classroom-based smoking prevention and cessation intervention program. Addictive Behaviors, 32(12), 3005-3014.Link provided by the sponsor.
- Sidhu, A. K., Sussman, S., Tewari, A., Bassi, S., \& Arora, M. (2016). Project EX-India: A classroom-based tobacco use prevention and cessation intervention program. Addictive Behaviors, 53, 53-57.Link provided by the sponsor.
- Gonzálvez, M. T., Espada, J. P., Orgilés, M., Soto, D., \& Sussman, S. (2015). One-year effects of Project EX in Spain: A classroom-based smoking prevention and cessation intervention program. PLOS ONE, 10(6).Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. A decision regarding the sharing of IPD has not yet been made. This will be determined in consultation with the supervisor and will depend on participant consent and the ability to adequately de-identify the data.
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.
Naseem Akhtar, PhD Scholar principal investigator
Institute of clinical psychology, University of Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project EX in people with Focus of the Study is Smoking Cessation and Prevention and Smoking Prevention, run by University of Karachi at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 26 Oct 2026. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naseem Akhtar, PhD scholar (00923106090031, naseempsy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Mean motivation to quit tobacco use Score . (time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)). The study lists 12 primary outcomes in all. 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 26 Oct 2026.