Addressing Parental Tobacco Use in Somali Immigrant Families: Adapting an Evidence-Based Intervention in Primary Care

Addressing Parental Tobacco Use in Somali Immigrant Families: Adapting an Evidence-based Intervention in Pediatric Primary Care

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Smoking; Smoking Cessation
• Intervention / Treatment: Behavioral: CEASE+

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: April Wilhelm, MD, MPH; Phone Number: 612-625-1654; Email: awilhelm@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CEASE+; Clinician- and/or staff-delivered messaging and tobacco cessation resources to Somali parents who smoke

Behavioral: CEASE+; The intervention will be delivered by the clinician to smoking parents who attend the office visit and to smoking parents not present at the visit via resources sent home with a non-smoking parent. If the smoking parent is present in clinic, the intervention consists of a brief, clinician- delivered motivational intervention that includes messaging around the risks of household smoking, verbal recommendation for establishing home/car smoke-free rules, a printed prescription for nicotine replacement therapy and quitline information, and messaging on the benefits of cessation and a quitline referral. If the smoking parent is not present in clinic, the intervention will include clinician-delivered messaging to the non-smoking parent to share CEASE+ resources with the parent who smokes and an invitation for the parent who smokes to participate in a single call delivered by a culturally-/linguistically-congruent community health worker to connect them to CEASE+ resources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of parents who received motivational intervention	The proportion of parents who report receipt of this tobacco cessation resource (dichotomous - yes/no)	baseline
Proportion of parents who received a verbal recommendation for smoke- free home/care rules	The proportion of parents who report receipt of this tobacco cessation resource (dichotomous - yes/no)	baseline
Proportion of parents who received nicotine replacement therapy (NRT)	The proportion of parents who report receipt of this tobacco cessation resource (dichotomous - yes/no)	baseline
Proportion of parents who received a quitline referral	The proportion of parents who report receipt of this tobacco cessation resource (dichotomous - yes/no)	baseline
Percent completion of adapted protocol content	The mean percent completion of adapted protocol participants	baseline
Mean duration of telephone call	The mean duration of the coaching call (minutes)	baseline
Change in parental smoker utilization of NRT	The change in the proportion of parental smoker utilization of NRT between baseline and 3 month follow up	baseline, 3months
Change in parental smoker utilization of quitline referrals	The change in the proportion of parental smoker utilization of quitline referrals between baseline and 3 month follow	baseline, 3 months
Survey completion rate verification	The proportion of questions completed relative	baseline, 3 months
Mean duration of telephone survey	The mean duration of telephone survey calls at baseline and 3 month follow up	baseline, 3 months
Participation rate of recruitment (approached)	The proportion of participants recruited over the proportion of participants approached	baseline
Participation rate of recruitment (eligible)	The proportion of participants recruited over the proportion of participants who are eligible based on a positive household	Baseline
Retention of participants for follow-up	The proportion of participants who remain in the study at the 3 month follow up time point	3 month follow up
Abstinence verification participation	The proportion of participants reporting abstinence at 3 months who submit a sample for iCO biochemical verification	3 month followup
Mean participant satisfaction with CEASE+ materials	Mean participant satisfaction score measured with 5-point Likert scale score (0 = strongly dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, 4=strongly satisfied)	baseline
Mean participant satisfaction with in-clinic motivational intervention	Mean participant satisfaction score measured with 5-point Likert scale score (0 = strongly dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, 4=strongly satisfied)	baseline
Mean participant satisfaction with telephone- call delivered motivational intervention	Mean participant satisfaction score measured with 5-point Likert scale score (0 = strongly dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, 4=strongly satisfied)	baseline
Mean participant satisfaction with CEASE+ messaging	Mean participant satisfaction score measured with 5-point Likert scale score (0 = strongly dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, 4=strongly satisfied)	baseline
Mean participant satisfaction with study procedures (baseline)	Mean participant satisfaction score measured with 5-point Likert scale score (0 = strongly dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, 4=strongly satisfied)	Baseline
Mean participant satisfaction with study procedures (follow up)	Mean participant satisfaction score measured with 5-point Likert scale score (0 = strongly dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, 4=strongly satisfied)	3 month followup

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parental cigarette smoking abstinence	7-day point prevalence abstinence of combustible	3 month follow up
Total tobacco product abstinence	7-day point prevalence abstinence of all tobacco products including shisha, cigars, chew, e-cigarettes	3 month follow up
Change in cigarette smoking heaviness	Change in the heaviness of cigarette smoking score from baseline to 3 month follow up using the Heaviness of Smoking index measure	baseline and 3 month follow up
Change in the frequency of other tobacco use	Change from baseline and 3 months in the proportion of parental smoker reported use of other forms of tobacco as a combined measure (i.e., e-cigarettes, hookah, cigars, etc.)	baseline and 3 month follow up
Change in the presence of smoke-free home/car rules	Change from baseline to 3 month follow up in the proportion of participants who report the presence of smoke-free home/car rules using a 2-item measure "House Rules about	baseline and 3 month follow up

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: April Wilhelm, MD, MPH, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: February 16, 2025
• First Posted (Actual): February 21, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking; Smoking Cessation
• Other Study ID Numbers: FMCH-2024-33169

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No