Clinical trial NCT06839729: Addressing Parental Tobacco Use in Somali Immigrant Families: Adapting an Evidence-Based Intervention in Primary Care
Official title: Addressing Parental Tobacco Use in Somali Immigrant Families: Adapting an Evidence-based Intervention in Pediatric Primary Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Smoking
Smoking Cessation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will modify an existing evidence-based parental tobacco cessation intervention (the Clinical Effort Against Secondhand Smoke Exposure, or CEASE) delivered in pediatric primary care clinics to address shared tobacco use determinants and barriers to smoking cessation treatment among Somali Americans, an immigrant population facing significant combustible tobacco use disparities.

Detailed description: Smoking is a significant and growing concern within U.S. Somali immigrant populations, who experience unique barriers to accessing and using tobacco treatments developed for the general population. Household smoking exposes Somali families to second- and thirdhand smoke with related negative health consequences and influences children's tobacco use beliefs and future behaviors. This study will modify and then pilot test an existing evidence-based parental tobacco cessation intervention (the Clinical Effort Against Secondhand Smoke Exposure, or CEASE) delivered in pediatric primary care clinics to address shared tobacco use determinants and barriers to smoking cessation treatment among Somali Americans. This new intervention, CEASE+, will increase access to and utilization of tobacco cessation treatment for Somali parents through brief clinician- and staff-delivered messaging and tobacco cessation resources. The project will take place in two phases. In phase 1, the investigators will modify the existing intervention to develop CEASE+ by conducting focus groups with Somali parents who smoke and non-smokers who live with adults who smoke and with the help of a community advisory board. In phase 2, we will conduct a pilot study of the new intervention, CEASE+, with Somali parents in 2 pediatric primary care clinics (n=50 parents who smoke). Primary outcomes will include feasibility and acceptability of CEASE+ intervention components and study procedures.

Secondary outcomes will include cigarette smoking abstinence and total tobacco abstinence at 3 months and changes in cigarette smoking heaviness between baseline and 3 months.

Eligibility criteria: Inclusion Criteria:

* age over 18 years
* self-reported 1 st or 2 nd generation Somali identity
* parent or legal guardian at least one pediatric patient within the MHF system
* self-reported use of combustible cigarettes (even a puff) in the past 30 days
* access to a telephone

Exclusion Criteria:

Clinician or staff participant:

* Inability or unwillingness to participate in implementing CEASE+
* Employees or students of the research team

Parent participant:

* Having participated in Aim 1

Primary outcomes:
measure: Proportion of parents who received motivational intervention
timeFrame: baseline
measure: Proportion of parents who received a verbal recommendation for smoke- free home/care rules
timeFrame: baseline
measure: Proportion of parents who received nicotine replacement therapy (NRT)
timeFrame: baseline
measure: Proportion of parents who received a quitline referral
timeFrame: baseline
measure: Percent completion of adapted protocol content
timeFrame: baseline
measure: Mean duration of telephone call
timeFrame: baseline
measure: Change in parental smoker utilization of NRT
timeFrame: baseline, 3months
measure: Change in parental smoker utilization of quitline referrals
timeFrame: baseline, 3 months
measure: Survey completion rate verification
timeFrame: baseline, 3 months
measure: Mean duration of telephone survey
timeFrame: baseline, 3 months
measure: Participation rate of recruitment (approached)
timeFrame: baseline
measure: Participation rate of recruitment (eligible)
timeFrame: Baseline
measure: Retention of participants for follow-up
timeFrame: 3 month follow up
measure: Abstinence verification participation
timeFrame: 3 month followup
measure: Mean participant satisfaction with CEASE+ materials
timeFrame: baseline
measure: Mean participant satisfaction with in-clinic motivational intervention
timeFrame: baseline
measure: Mean participant satisfaction with telephone- call delivered motivational intervention
timeFrame: baseline
measure: Mean participant satisfaction with CEASE+ messaging
timeFrame: baseline
measure: Mean participant satisfaction with study procedures (baseline)
timeFrame: Baseline
measure: Mean participant satisfaction with study procedures (follow up)
timeFrame: 3 month followup
Secondary outcomes:
measure: Parental cigarette smoking abstinence
timeFrame: 3 month follow up
measure: Total tobacco product abstinence
timeFrame: 3 month follow up
measure: Change in cigarette smoking heaviness
timeFrame: baseline and 3 month follow up
measure: Change in the frequency of other tobacco use
timeFrame: baseline and 3 month follow up
measure: Change in the presence of smoke-free home/car rules
timeFrame: baseline and 3 month follow up
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: April Wilhelm, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: