A Program to Protect Young Children From Tobacco Smoke Exposure
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Tel Aviv University
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Child exposure to tobacco smoke - hair nicotine
Study Overview
Brief Summary
The goal of this research project is to develop and evaluate an intervention to reduce young child tobacco smoke exposure
Detailed Description
Goals The primary goal of this research is to develop and test a theory-based intervention which will reduce tobacco smoke exposure (TSE) of young children. A secondary goal is to increase knowledge of measurement of TSE in young children, and explore the relationship between early TSE, illness, and health care utilization. The study is being conducted in several stages: Developmental (Phase I), Pilot (Phase II), and Trial (Phase III). This registration pertains to Phase II of this trial.
Developmental Stage (Phase I)
This stage includes the following: Systematic reviews of the literature on the topics of encouraging i. parental cessation, ii.reducing child tobacco smoke exposure (TSE), and iii.reducing tobacco smoke air pollution in homes; consultations with experts worldwide; conduct of interviews with parents (n=65) and professionals (n=15) to understand parental perceptions of tobacco smoke exposure, and barriers to protection of children from TSE; and development of an initial intervention program. This stage draws on a social marketing approach and employs in-depth interviews to identify barriers to behavior change and relevant behavior-change recommendations, tailored to the intervention population, and to test the acceptability of program components.
Intervention Program
The intervention consisted of the following elements: (a) Three motivational interviews, scheduled for baseline, one month, and three months; (b) Feedback on air quality in the home (from a Sidepak and/or a Dylos monitoring device, and from passive air nicotine dosimeters); (c) Feedback on child's exposure via hair samples analyzed for nicotine; (d) a website designed especially for the project [22];and (e) various self-help materials, including a booklet, a magnet about TSE, and air fresheners.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- — to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •At least one parent was a current smoker. The child was of the appropriate age (<8 years of age). The child had sufficient hair growth for hair samples. A parent gave consent for participation in the research. The parent can communicate in Hebrew.
Exclusion Criteria
- •One of above conditions not met
Arms & Interventions
Intervention
Participants received the behavioral intervention, which was designed to motivate parents to protect their children from tobacco smoke exposure
Intervention: Intervention (Behavioral)
Outcomes
Primary Outcomes
Child exposure to tobacco smoke - hair nicotine
Time Frame: Baseline, 6 months post-intervention
Child exposure to tobacco smoke as assessed by hair nicotine level
Secondary Outcomes
- Child health status(Baseline, 6 months post-intervention (continuous))
- Respirable Small Particle (RSPs - PM2.5) level in home(Baseline, 1 month post-intervention)
- Child exposure to tobacco smoke - parental report(Baseline, 6 months post-intervention)
- Air nicotine(Baseline, 6 months post-intervention)
Investigators
Laura Rosen
Chair, Dept. of Health Promotion, School of Public Health, Sackler Faculty of Medicine
Tel Aviv University