Passive Smoking
Conditions
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.
Interventions
BEHAVIORALBehavioral Early
Participants will receive an intervention which includes motivational interviewing, biochemical feedback, air quality feedback, phone calls, and social media
BEHAVIORALBehavioral Late
After the close of the study, Participants will receive an intervention which includes motivational interviewing, biochemical feedback, air quality feedback, phone calls, and social media
Sponsors
Flight Attendant Medical Research Institute (FAMRI)
Hebrew University
Assaf-Harofeh Medical Center
Tel Aviv University
Laura J. Rosen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 8 Years
Healthy volunteers
Yes
Inclusion criteria
for RCT : 1. \- Families in which at least one parent smokes, and both parents combined smoke a minimum of 10 cigarettes per week 2. \- Parents willing to provide child hair samples 3. \- Hebrew speaking participants 4. \- Parents are willing to participate from time of entry for the coming 8 months .
Exclusion criteria
There are no additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in child exposure to tobacco smoke as assessed by log hair nicotine | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in smoking practices in the home as reported by parents | Baseline and 6 months post-enrollment | Smoking practices in the home as measured by a single question |
| Change in parental smoking | Baseline and 6 months post-enrollment | Parental quit rates |
| Change in parental perceptions of risk due to smoking, intervention and expanded control groups | Baseline and 6 months post-enrollment | Measurement of risk resulting in a single composite number using a validated questionnaire |
| Change in parental perceptions of tobacco smoke exposure, intervention and expanded control groups | Baseline and 6 months post-enrollment | Measurement of exposure perceptions resulting in a single composite number using a validated questionnaire |
| Child health | 6 months post-enrollment | Number of child illnesses related to tobacco smoke exposure |
| Child health services utilization | 6 months post-enrollment | Number of visits to physicians or emergency care services |
| Change in child exposure to tobacco smoke as assessed by parental report | Baseline and 6 months post-enrollment | Frequency of child exposure to tobacco smoke as measured by a single question |
| Change in parentally-reported number of cigarettes smoked | Baseline and 6 months post-enrollment | Reported number of cigarettes smoked by parents daily |
| Change in parentally-reported child exposure to tobacco smoke, intervention and expanded control groups | Baseline and 6 months post-enrollment | Detailed parental report on when and how often child is exposed to tobacco smoke, as summarized by composite scale |
| Parental perceptions of risk due to smoking, intervention versus control group | 6 months post-enrollment | Measurement of risk perceptions resulting in a single composite number using a validated questionnaire |
| Parental perceptions of tobacco smoke exposure, intervention versus control group | 6 months post-enrollement | Measurement of exposure perceptions resulting in a single composite number using a validated questionnaire |
| Correlations between parentally-reported exposure and child log hair nicotine | baseline | Pearson correlations |
| Change in smoking practices in the car as reported by parents | Baseline and 6 months post-enrollment | Frequency of smoking in the car (single question) |
Countries
Israel
Outcome results
None listed