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

Phase 1Not Yet RecruitingNCT06839729

University of Minnesota50 enrolled

Overview

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.

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

Allocation

Purpose

OTHER

Masking

NONE

Conditions

Smoking Smoking Cessation

Interventions

CEASE+BEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of parents who received motivational intervention

The proportion of parents who report receipt of this tobacco cessation resource (dichotomous - yes/no)

Time frame: 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)

Time frame: 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)

Time frame: baseline

Proportion of parents who received a quitline referral

The proportion of parents who report receipt of this tobacco cessation resource (dichotomous - yes/no)

Time frame: baseline

Percent completion of adapted protocol content

The mean percent completion of adapted protocol participants

Time frame: baseline

Mean duration of telephone call

The mean duration of the coaching call (minutes)

Time frame: 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

Time frame: 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

Central Contacts

April Wilhelm, MD, MPH

CONTACT

612-625-1654 awilhelm@umn.edu

Data from ClinicalTrials.gov

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Secondary Outcomes

Parental cigarette smoking abstinence

7-day point prevalence abstinence of combustible

Time frame: 3 month follow up

Total tobacco product abstinence

7-day point prevalence abstinence of all tobacco products including shisha, cigars, chew, e-cigarettes

Time frame: 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

Time frame: 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.)

Time frame: 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

Time frame: baseline and 3 month follow up