Clinical trial Recruiting at 3 sites Interventional Ages 18 and up

Smoking cessation for parents with health navigator support to tackle social needs

Official title: A Randomized Controlled Trial of a Smoking Cessation Intervention Including Health Navigators to Address Unmet Social Needs of Parents Who Smoke

Run by St. Justine's Hospital · NCT06651684 · Data updated 2026-11-12

We’re testing a program that helps parents quit smoking and also addresses their social challenges to reduce kids’ exposure to secondhand smoke.

More Smoking Cessation trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment1000 (estimated)
SponsorSt. Justine's Hospital
Academic / other
Locations3 sites (Montreal, Quebec and 2 other locations)
StatusRecruiting
StartedMarch 26, 2026
Main results expectedFebruary 2029
Study endsFebruary 2030
Registry record updatedJuly 24, 2026
Trial IDNCT06651684 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are parents or legal guardians of children 0-17 who smoke and report at least one social risk and can communicate in French or English.

Probably not a fit

Participants without detectable social barriers or who do not smoke may not benefit from the program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial tests a combined approach in real-world pediatric clinics to help parents quit smoking and address unmet social needs using a health navigator. Eligible participants are parents or guardians of children under 18 with at least one social risk, recruited from two Montreal-area centers. Participants are randomized to receive a structured smoking cessation intervention plus health navigation to resolve social barriers, versus usual care. The study aims to measure quit rates and changes in child secondhand smoke exposure, alongside engagement with social services. Enrollment targets 1,000 participants over 2.5 years.

Why it matters

Potential benefit: If successful, the program could improve child health by reducing secondhand smoke exposure and helping families access social supports.

How similar studies have gone: Prior work shows mixed success with integrated behavioral and social support approaches; this trial tests a combined strategy in a real-world setting.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Parents or legal guardians aged ≥18 years, with child(ren) aged 0-17 years, attending a regular scheduled medical appointment in one of the study sites.
* Pregnant patients aged ≥18 years who are parents or legal guardians of child(ren) aged 0-17 years coming in for an prenatal appointment.
* Smokers with at least one self-reported social risk as assessed by validated screening questions on the domains employment, housing stability, ability to pay for utilities, financial resource strain, food security, transportation, childcare, parent education and health literacy.
* Sufficiently proficient in French or English to understand and complete study questionnaires.

Exclusion Criteria:

* Families presenting at the clinic for an urgent medical issue.
* Parents without at least one social risk.
* If both parents smoke, only one parent will be eligible to participate.

Where it's running

  • Maisonneuve-Rosemont Hospital
    Montreal, Quebec, Canada
    Recruiting
  • Pediatric Clinic of the CHU Sainte-Justine
    Montreal, Quebec, Canada
    Recruiting
  • Pierre-Le Gardeur Hospital
    Montreal, Quebec, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.