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

NCT06839729 | Not Yet Recruiting Phase 1

• 1 other identifier: FMCH-2024-33169
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Smoking; Smoking Cessation

Outcome Measures

Primary Outcomes (20)

• 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 Outcomes (5)

• Parental cigarette smoking abstinence

  3 month follow up

• Total tobacco product abstinence

  3 month follow up

• Change in cigarette smoking heaviness

  baseline and 3 month follow up

• Change in the frequency of other tobacco use

  baseline and 3 month follow up

• Change in the presence of smoke-free home/car rules

  baseline and 3 month follow up

Study Arms (1)

CEASE+

EXPERIMENTAL

Clinician- and/or staff-delivered messaging and tobacco cessation resources to Somali parents who smoke

Behavioral: CEASE+

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.

CEASE+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

MeSH Terms

Conditions

Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Study Officials

• April Wilhelm, MD, MPH

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

April Wilhelm, MD, MPH

CONTACT

612-625-1654; awilhelm@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: February 21, 2025
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02