Addressing Parental Tobacco Use in Somali Immigrant Families: Adapting an Evidence-Based Intervention in Primary Care
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Minnesota
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Inability or unwillingness to participate in implementing CEASE+
Employees or students of the research team
Having participated in Aim 1
Trial design
Design model
Single group
Treatments tested in this trial
CEASE+
BehavioralThe 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: CEASE+Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of parents who received motivational intervention
The proportion of parents who report receipt of this tobacco cessation resource (dichotomous - yes/no)
Time frame
baseline2
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
baseline3
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
baseline4
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
baselineSecondary outcomes
1
Parental cigarette smoking abstinence
7-day point prevalence abstinence of combustible
Time frame
3 month follow up2
Total tobacco product abstinence
7-day point prevalence abstinence of all tobacco products including shisha, cigars, chew, e-cigarettes
Time frame
3 month follow up3
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 up4
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 upLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: