A Program to Protect Young Children From Tobacco Smoke Exposure

Study Overview
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Brief Summary
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The goal of this research project is to develop and evaluate an intervention to reduce young child tobacco smoke exposure

Detailed Description
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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. Pilot (Phase II) A pilot of the planned intervention was conducted with 29 families. A before - and - after design was used, without a control group. The main endpoint was child exposure to tobacco smoke as measured by hair nicotine. Secondary endpoints included child exposure to tobacco smoke as measured by parental reports, family smoking in home or car, home air nicotine, child illnesses, and use of health services. [Randomized Controlled Trial (Phase III) (Note: a separate registration number is being sought for this phase) The investigators plan to implement and evaluate the intervention using a randomized controlled trial with an estimated 120 participants. The primary response variable will be child tobacco smoke exposure as measured by hair nicotine. The control group will be offered the intervention at the end of the study (eg, a randomize-to-wait-list design). ] An effective program for child tobacco smoke exposure reduction could serve as a prototype for reducing child tobacco smoke exposure.

Official Title
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A Program to Protect Young Children From Tobacco Smoke Exposure

Conditions
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Child Exposure to Tobacco Smoke

Intervention / Treatment
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* Behavioral: Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants received the behavioral intervention, which was designed to motivate parents to protect their children from tobacco smoke exposure | Behavioral: Intervention<br>* 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 (PM2.5 was measured using a Sidepak and/or a Dylos monitoring device, and air nicotine was measured using passive air nicotine dosimeters); (c) Feedback on child's exposure via hair nicotine; (d) a website designed especially for the project [parents.org.il];and (e) various self-help materials, including a booklet, a magnet about TSE, and air fresheners.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child exposure to tobacco smoke - hair nicotine | Child exposure to tobacco smoke as assessed by hair nicotine level | Baseline, 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child exposure to tobacco smoke - parental report | Child exposure to tobacco smoke as measured by parental report | Baseline, 6 months post-intervention | 
| Child health status | Incidence of respiratory events as reported by parents | Baseline, 6 months post-intervention (continuous) | 
| Respirable Small Particle (RSPs - PM2.5) level in home | Measurement of RSPs in the home over a 24-hour period | Baseline, 1 month post-intervention | 
| Air nicotine | Passive nicotine dosimeters were used for 1 7-day period in the home | Baseline, 6 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tobacco smoke exposure, Secondhand smoke exposure, Passive smoking, Child health, Prevention, Tobacco control, Motivational Interviewing, Air quality, Pilot Study