An Intervention to Protect Young Children From Tobacco Smoke Exposure
Overview
- Phase
- Phase 3
- Sponsor
- Laura J. Rosen
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Change in child exposure to tobacco smoke as assessed by log hair nicotine
Overview
Brief Summary
The primary goal of this research is to evaluate the effectiveness of an intervention for parents to reduce tobacco smoke exposure of young children
Detailed Description
The primary aim of this intervention is to reduce exposure of children to tobacco smoke, through an intervention program designed to help parents better perceive exposure and its harms, and to provide tools for assisting them in protecting children. Secondary aims are to understand the relationships between parentally-reported and objectively measured child tobacco smoke exposure, to assess the relationship between tobacco smoke exposure and health and health care utilization, and to better understand parental perceptions of tobacco smoke exposure (PPE) and parental perceptions of risk (PPR) from tobacco smoke exposure. The effectiveness of the intervention will be evaluated using a randomized controlled trial.
This RCT is a continuation of previous work. Originally the entire research project, which included a Pilot Study and a Randomized Controlled Trial (RCT) was registered as NCT01335178. Upon completion of the Pilot Study, we closed NCT01335178 and opened a new one for the RCT with the current registration number.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 8 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- •There are no additional exclusion criteria
Outcomes
Primary Outcomes
Change in child exposure to tobacco smoke as assessed by log hair nicotine
Time Frame: Baseline and 6 months post-enrollment
A small amount of hair will be taken from the child's head near the scalp and sent to a laboratory for analysis
Secondary Outcomes
- Change in smoking practices in the car as reported by parents(Baseline and 6 months post-enrollment)
- Child health services utilization(6 months post-enrollment)
- Change in parentally-reported child exposure to tobacco smoke, intervention and expanded control groups(Baseline and 6 months post-enrollment)
- Parental perceptions of risk due to smoking, intervention versus control group(6 months post-enrollment)
- Parental perceptions of tobacco smoke exposure, intervention versus control group(6 months post-enrollement)
- Correlations between parentally-reported exposure and child log hair nicotine(6 months)
- Change in smoking practices in the home as reported by parents(Baseline and 6 months post-enrollment)
- Change in parental perceptions of tobacco smoke exposure, intervention and expanded control groups(Baseline and 6 months post-enrollment)
- Change in parentally-reported number of cigarettes smoked(Baseline and 6 months post-enrollment)
- Change in parental perceptions of risk due to smoking, intervention and expanded control groups(Baseline and 6 months post-enrollment)
- Child health(6 months post-enrollment)
- Change in child exposure to tobacco smoke as assessed by parental report(Baseline and 6 months post-enrollment)
- Change in parental smoking(Baseline and 6 months post-enrollment)
Investigators
Laura J. Rosen
Senior Lecturer and Chair, Dept. of Health Promotion
Tel Aviv University