RecruitingNot ApplicableNCT06651684

Smoking Cessation Intervention Including Health Navigators to Address Unmet Social Needs of Parents Who Smoke

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


Sponsor

St. Justine's Hospital

Enrollment

1,000 participants

Start Date

Mar 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Background: The goal of this study is to address parental smoking and social adversity, which can present an obstacle for smoking cessation, in order to decrease childhood exposure to second-hand cigarette smoke. To address these factors, this study includes a smoking cessation intervention for parents and legal guardians recruited in pediatric clinics (CanCEASE), as well as the support of a Health Navigator (HN) to work with the participant towards the resolution or mitigation of unmet social needs. Participants: The research team will recruit one thousand participants from pediatric outpatient clinics within two healthcare centres in and around the city of Montreal, Canada, over the course of 2.5 years. Eligible persons are parents and legal guardians, of any sex and gender, accompanying children under 18 to their scheduled medical appointments, and who report at least one social risk in selected areas (i.e., employment, housing stability, ability to pay for utilities, financial resource strain, food security, transportation, childcare, parent education and health literacy). Participants must also be 18 years old or older with sufficient proficiency in French or English to complete the interviews and questionnaires. In households in which both parents smoke, only one will be eligible to participate, but smoking cessation information will be offered to both. Families presenting at the clinic for an urgent medical issue are not eligible to participate. Intervention: Participants will be divided into control group (care as usual with CanCEASE at the end of the study period) and intervention (CanCEASE + Health navigator). All participants will complete questionnaires at Baseline, 6 and 12 months. The intervention group will receive CanCEASE at the end of each questionnaire. Controls will receive CanCEASE at 12 months. The intervention group will have the possibility to meet with the HNs and will be invited to commit to at least two sessions (i.e.: evaluation and a follow up), with the option to book more time as needed. Aims and hypotheses: Examining how effective the combination of CanCEASE with HN support is in helping parents with unmet social needs quit smoking. Investigators will also examine the effects of the intervention on status of unmet social needs, if the intervention was implemented as planned and well accepted by clinics and participants, and what is the cost of the intervention for each person who quits smoking.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria3

  • 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.

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Interventions

BEHAVIORALCanCEASE with Health Navigator

CanCEASE is a digital intervention to identify parents who smoke, assess their motivation and willingness to quit, as well as to provide direct linkage to evidence-based smoking interventions, including effective behavioural and pharmacological resources that can be used alone or in combination. Participants will have the choice to receive CanCEASE at three timepoints (0, 6 and 12 months). CanCEASE will be combined with an offer of support sessions with a Health Navigator. Health Navigators will be research personnel hired specifically for this study and trained formally in health navigation, tobacco cessation counseling and strategies to address unmet social needs. The investigators will leverage knowledge and experience of two ongoing RCTs of HNs in pediatrics to inform training strategies.


Locations(3)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Pediatric Clinic of the CHU Sainte-Justine

Montreal, Quebec, Canada

Pierre-Le Gardeur Hospital

Montreal, Quebec, Canada

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NCT06651684


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