Addressing Parental Tobacco Use in Somali Immigrant Families: Adapting an Evidence-based Intervention in Pediatric Primary Care
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Proportion of parents who received motivational intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
CEASE+
Clinician- and/or staff-delivered messaging and tobacco cessation resources to Somali parents who smoke
干预措施: CEASE+ (Behavioral)
结局指标
主要结局
Proportion of parents who received motivational intervention
时间窗: 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
时间窗: 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)
时间窗: baseline
The proportion of parents who report receipt of this tobacco cessation resource (dichotomous - yes/no)
Proportion of parents who received a quitline referral
时间窗: baseline
The proportion of parents who report receipt of this tobacco cessation resource (dichotomous - yes/no)
Percent completion of adapted protocol content
时间窗: baseline
The mean percent completion of adapted protocol participants
Mean duration of telephone call
时间窗: baseline
The mean duration of the coaching call (minutes)
Change in parental smoker utilization of NRT
时间窗: 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
时间窗: 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
时间窗: baseline, 3 months
The proportion of questions completed relative
Mean duration of telephone survey
时间窗: baseline, 3 months
The mean duration of telephone survey calls at baseline and 3 month follow up
Participation rate of recruitment (approached)
时间窗: baseline
The proportion of participants recruited over the proportion of participants approached
Participation rate of recruitment (eligible)
时间窗: 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
时间窗: 3 month follow up
The proportion of participants who remain in the study at the 3 month follow up time point
Abstinence verification participation
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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)
次要结局
- 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)