SmokingPhase 1NCT06839729
Addressing Parental Tobacco Use in Somali Immigrant Families: Adapting an Evidence-Based Intervention in Primary Care
A Phase 1 study testing CEASE+ in people with Smoking and Smoking Cessation, run by University of Minnesota.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Cessation
- What is being tested?
- CEASE+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 31 Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Addressing Parental Tobacco Use in Somali Immigrant Families: Adapting an Evidence-based Intervention in Pediatric 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.
Read the 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.
- Conditions
- Smoking, Smoking Cessation
- Being tested
- CEASE+
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEASE+Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CEASE+ | Experimental | Clinician- and/or staff-delivered messaging and tobacco cessation resources to Somali parents who smoke Receives: Behavioral: CEASE+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of parents who received motivational intervention
The proportion of parents who report receipt of this tobacco cessation resource (dichotomous - yes/no)
Measured: 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)
Measured: 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)
Measured: baseline
Proportion of parents who received a quitline referral
The proportion of parents who report receipt of this tobacco
cessation resource (dichotomous - yes/no)
Measured: baseline
Percent completion of adapted protocol content
The mean percent completion of adapted protocol participants
Measured: baseline
Mean duration of telephone call
The mean duration of the coaching call (minutes)
Measured: 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
Measured: 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
Measured: baseline, 3 months
Survey completion rate verification
The proportion of questions completed relative
Measured: baseline, 3 months
Mean duration of telephone survey
The mean duration of telephone survey calls at baseline and 3 month follow up
Measured: baseline, 3 months
Participation rate of recruitment (approached)
The proportion of participants recruited over the proportion of
participants approached
Measured: baseline
Participation rate of recruitment (eligible)
The proportion of participants recruited over the proportion of participants who are eligible based on a positive household
Measured: Baseline
Retention of participants for follow-up
The proportion of participants who remain in the study at the 3 month follow up time point
Measured: 3 month follow up
Abstinence verification participation
The proportion of participants reporting abstinence at 3 months who submit a sample for iCO biochemical verification
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 3 month followup
Secondary outcomes (5)
Parental cigarette smoking abstinence
7-day point prevalence abstinence of combustible
Measured: 3 month follow up
Total tobacco product abstinence
7-day point prevalence abstinence of all tobacco products including shisha, cigars, chew, e-cigarettes
Measured: 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
Measured: 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.)
Measured: 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
Measured: baseline and 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- April Wilhelm, MD, MPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839729
- Sponsor's protocol ID
- FMCH-2024-33169
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Parental Tobacco Use in Somali Immigrant Families: Adapting an Evidence-based Intervention in Pediatric Primary Care
- ClinicalTrials.gov ID
- NCT06839729
- Acronym / sponsor ID
- FMCH-2024-33169
- Conditions
- Smoking, Smoking Cessation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CEASE+ | Experimental | Behavioral: CEASE+Clinician- and/or staff-delivered messaging and tobacco cessation resources to Somali parents who smoke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Inability or unwillingness to participate in implementing CEASE+
- Employees or students of the research team
- Having participated in Aim 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CEASE+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. | Behavioural | CEASE+ |
Primary outcome
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)
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)
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)
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)
Percent completion of adapted protocol content
Time frame: baseline
The mean percent completion of adapted protocol participants
Mean duration of telephone call
Time frame: baseline
The mean duration of the coaching call (minutes)
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
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
Survey completion rate verification
Time frame: baseline, 3 months
The proportion of questions completed relative
Mean duration of telephone survey
Time frame: baseline, 3 months
The mean duration of telephone survey calls at baseline and 3 month follow up
Participation rate of recruitment (approached)
Time frame: baseline
The proportion of participants recruited over the proportion of participants approached
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
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
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
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)
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)
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)
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)
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)
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)
5 secondary outcomes
Parental cigarette smoking abstinence
Time frame: 3 month follow up
Total tobacco product abstinence
Time frame: 3 month follow up
Change in cigarette smoking heaviness
Time frame: baseline and 3 month follow up
Change in the frequency of other tobacco use
Time frame: baseline and 3 month follow up
Change in the presence of smoke-free home/car rules
Time frame: baseline and 3 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
April Wilhelm, MD, MPH principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CEASE+ in people with Smoking and Smoking Cessation, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact April Wilhelm, MD, MPH (612-625-1654, awilhelm@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of parents who received motivational intervention (time frame: baseline). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.