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Not yet recruitingNCT07895784Updated Oct 26, 2026

Effectiveness Of Project EX: A Classroom-Based Smoking Prevention And Cessation Intervention Program

An interventional study of Project EX in Focus of the Study is Smoking Cessation and Prevention and Smoking Prevention, sponsored by University of Karachi. Not yet recruiting at 1 site in Pakistan. Open to participants aged 14 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by University of Karachi · Not applicable, Interventional, and Other

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Non-randomized
Ages
14 Years to 18 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Focus of the Study is Smoking Cessation and Prevention
  • Smoking Prevention
03

In context

Smoking

1,509 studies on the registry are indexed under Smoking; 193 are open to participants now.

This study's planned enrollment of 600 is above the median of 115 across 1,164 interventional studies indexed under Smoking.

Browse Smoking studies →

Lead sponsor

University of Karachi is the lead sponsor of 37 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    Intervention Group will receive the intervention which is Project EX

    Behavioral: Project EX

  • No intervention
    Standard care control

    Standard care control Group will not receive the intervention which is Project EX

Interventions

  • BehavioralProject EX

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)

  2. 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.

    Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)

  3. 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.

    Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)

  4. Change from Baseline in Mean Self control Score

    Scale assessing self control items. Higher scores indicate greater self-control.

    Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)

  5. Change from Baseline in Mean depression Score

    Measured with the Center for Epidemiologic Studies Depression Scale (CES-D). Higher scores indicate more depressive symptoms.

    Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)

  6. Change from Baseline in Smoking-Related Knowledge

    Measured the health consequences of smoking. Higher scores indicate greater knowledge.

    Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)

  7. Change from Baseline in Endorsement of Tobacco Use Myths

    Measured on common misconceptions about tobacco use.

    Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)

  8. 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.

    Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)

  9. 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.

    Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)

  10. 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

    Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)

  11. 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.

    Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)

  12. 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.

    Time frame: Baseline, 6 weeks (post-intervention), and 6 months (follow-up)

07

Study locations

1 site
  • Imcbg-7/2
    Islamabad, Capital Territory, Pakistan
08

References and documents

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.

Of 401 non-industry interventional studies with no phase under Smoking, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 4 months is below that.

Counting every sponsor, half of 456 studies reached it within 23 months; a quarter within 8 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2026
First posted
Oct 26, 2026
StartEst.
Nov 10, 2026
Primary completionEst.
Mar 30, 2027
CompletionEst.
May 28, 2027
Last update
Oct 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07895784
Lead sponsor
University of Karachi
Responsible party
Naseem Akhtar (PhD Scholar, University of Karachi) — Principal investigator
First posted
Oct 26, 2026
Start date
Nov 10, 2026 (estimated)
Primary completion
Mar 30, 2027 (estimated)
Completion
May 28, 2027 (estimated)
Last update
Oct 26, 2026

Study contacts

Naseem Akhtar, PhD scholar
Contact
naseempsy@gmail.com
00923106090031
Naseem Akhtar, PhD Scholar
principal investigator · Institute of clinical psychology, University of Karachi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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