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

Phase 1

Not yet recruiting

• Conditions: Smoking; Smoking Cessation

• Registration Number: NCT06839729
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study First Submitted: 2025-01-23
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-16
• Last Update Submitted: 2025-02-16
• Study First Posted: 2025-02-21
• Last Update Posted: 2025-02-21
• Study Start: 2027-01-01
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Parental cigarette smoking abstinence	3 month follow up	7-day point prevalence abstinence of combustible
Total tobacco product abstinence	3 month follow up	7-day point prevalence abstinence of all tobacco products including shisha, cigars, chew, e-cigarettes
Change in cigarette smoking heaviness	baseline and 3 month follow up	Change in the heaviness of cigarette smoking score from baseline to 3 month follow up using the Heaviness of Smoking index measure
Change in the frequency of other tobacco use	baseline and 3 month follow up	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.)
Change in the presence of smoke-free home/car rules	baseline and 3 month follow up	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