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Not yet recruiting NCT06839729

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

Phase I Interventional Smoking Smoking Cessation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CEASE+.
Who it may be relevant to
Registry conditions: Smoking, Smoking Cessation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

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.

Interventions

  • Behavioral 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 replacem

Primary outcome measures

  • Proportion of parents who received motivational intervention [Time frame: baseline]
  • Proportion of parents who received a verbal recommendation for smoke- free home/care rules [Time frame: baseline]
  • Proportion of parents who received nicotine replacement therapy (NRT) [Time frame: baseline]
  • Proportion of parents who received a quitline referral [Time frame: baseline]
  • Percent completion of adapted protocol content [Time frame: baseline]
  • Mean duration of telephone call [Time frame: baseline]
  • Change in parental smoker utilization of NRT [Time frame: baseline, 3months]
  • Change in parental smoker utilization of quitline referrals [Time frame: baseline, 3 months]
  • Survey completion rate verification [Time frame: baseline, 3 months]
  • Mean duration of telephone survey [Time frame: baseline, 3 months]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06839729 · FMCH-2024-33169

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗