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NCT Number: NCT06839729

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

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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Proportion of parents who received motivational intervention

    Time frame: baseline

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

  2. Proportion of parents who received a verbal recommendation for smoke- free home/care rules

    Time frame: baseline

    The proportion of parents who report receipt of this tobacco

    cessation resource (dichotomous - yes/no)

  3. Proportion of parents who received nicotine replacement therapy (NRT)

    Time frame: baseline

    The proportion of parents who report receipt of this tobacco

    cessation resource (dichotomous - yes/no)

  4. Proportion of parents who received a quitline referral

    Time frame: baseline

    The proportion of parents who report receipt of this tobacco

    cessation resource (dichotomous - yes/no)

  5. Percent completion of adapted protocol content

    Time frame: baseline

    The mean percent completion of adapted protocol participants

  6. Mean duration of telephone call

    Time frame: baseline

    The mean duration of the coaching call (minutes)

  7. Change in parental smoker utilization of NRT

    Time frame: baseline, 3months

    The change in the proportion of parental smoker utilization of NRT between baseline and 3 month follow up

  8. Change in parental smoker utilization of quitline referrals

    Time frame: baseline, 3 months

    The change in the proportion of parental smoker utilization of quitline referrals between baseline and 3 month follow

  9. Survey completion rate verification

    Time frame: baseline, 3 months

    The proportion of questions completed relative

  10. Mean duration of telephone survey

    Time frame: baseline, 3 months

    The mean duration of telephone survey calls at baseline and 3 month follow up

  11. Participation rate of recruitment (approached)

    Time frame: baseline

    The proportion of participants recruited over the proportion of

    participants approached

  12. Participation rate of recruitment (eligible)

    Time frame: Baseline

    The proportion of participants recruited over the proportion of participants who are eligible based on a positive household

  13. Retention of participants for follow-up

    Time frame: 3 month follow up

    The proportion of participants who remain in the study at the 3 month follow up time point

  14. Abstinence verification participation

    Time frame: 3 month followup

    The proportion of participants reporting abstinence at 3 months who submit a sample for iCO biochemical verification

  15. Mean participant satisfaction with CEASE+ materials

    Time frame: baseline

    Mean participant satisfaction score measured with 5-point Likert scale score (0 = strongly dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, 4=strongly satisfied)

  16. Mean participant satisfaction with in-clinic motivational intervention

    Time frame: baseline

    Mean participant satisfaction score measured with 5-point Likert scale score (0 = strongly dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, 4=strongly satisfied)

  17. Mean participant satisfaction with telephone- call delivered motivational intervention

    Time frame: baseline

    Mean participant satisfaction score measured with 5-point Likert scale score (0 = strongly dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, 4=strongly satisfied)

  18. Mean participant satisfaction with CEASE+ messaging

    Time frame: baseline

    Mean participant satisfaction score measured with 5-point Likert scale score (0 = strongly dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, 4=strongly satisfied)

  19. Mean participant satisfaction with study procedures (baseline)

    Time frame: Baseline

    Mean participant satisfaction score measured with 5-point Likert scale score (0 = strongly dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, 4=strongly satisfied)

  20. Mean participant satisfaction with study procedures (follow up)

    Time frame: 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 outcomes

  1. Parental cigarette smoking abstinence

    Time frame: 3 month follow up

    7-day point prevalence abstinence of combustible

  2. Total tobacco product abstinence

    Time frame: 3 month follow up

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

  3. Change in cigarette smoking heaviness

    Time frame: 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

  4. Change in the frequency of other tobacco use

    Time frame: 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.)

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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

April Wilhelm, MD, MPH

CONTACT

[email protected]

612-625-1654

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
Feb 21, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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