An Intervention to Protect Young Children From Tobacco Smoke Exposure

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Intervention to Protect Young Children From Tobacco Smoke Exposure

Conditions
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Passive Smoking

Intervention / Treatment
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* Behavioral: Behavioral Early
* Behavioral: Behavioral Late


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for RCT : - Families in which at least one parent smokes, and both parents combined smoke a minimum of 10 cigarettes per week - Parents willing to provide child hair samples - Hebrew speaking participants - Parents are willing to participate from time of entry for the coming 8 months . Exclusion Criteria: There are no additional exclusion criteria -

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Motivational interviews (3 visits) + supportive phone calls Feedback of child hair nicotine levels Feedback of home air quality (PM2.5) New Media (Website and/or Facebook with information and parental forum) | Behavioral: Behavioral Early<br>* Participants will receive an intervention which includes motivational interviewing, biochemical feedback, air quality feedback, phone calls, and social media<br>|
| Other: Control Regular<br>This group will get no intervention during the study period. Following the close of the study, participants in this group will receive a shortened version of the intervention (1 motivational interview, with feedback on child hair nicotine levels and feedback on home air quality (PM2.5)) | Behavioral: Behavioral Late<br>* 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<br>|
| Other: Control Expanded<br>This group will get no intervention during the study period. However, participants will fill out a detailed questionnaire on parental perceptions of exposure and risk, as well as questions on social norms, self-efficacy, and knowledge Following the close of the study, participants in this group will receive a shortened version of the intervention (1 motivational interview, with feedback on child hair nicotine levels and feedback on home air quality (PM2.5)) | Behavioral: Behavioral Late<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in child exposure to tobacco smoke as assessed by log hair nicotine | A small amount of hair will be taken from the child's head near the scalp and sent to a laboratory for analysis | Baseline and 6 months post-enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in child exposure to tobacco smoke as assessed by parental report | Frequency of child exposure to tobacco smoke as measured by a single question | Baseline and 6 months post-enrollment | 
| Change in smoking practices in the home as reported by parents | Smoking practices in the home as measured by a single question | Baseline and 6 months post-enrollment | 
| Change in parental smoking | Parental quit rates | Baseline and 6 months post-enrollment | 
| Change in parental perceptions of risk due to smoking, intervention and expanded control groups | Measurement of risk resulting in a single composite number using a validated questionnaire | Baseline and 6 months post-enrollment | 
| Change in parental perceptions of tobacco smoke exposure, intervention and expanded control groups | Measurement of exposure perceptions resulting in a single composite number using a validated questionnaire | Baseline and 6 months post-enrollment | 
| Child health | Number of child illnesses related to tobacco smoke exposure | 6 months post-enrollment | 
| Child health services utilization | Number of visits to physicians or emergency care services | 6 months post-enrollment | 
| Change in smoking practices in the car as reported by parents | Frequency of smoking in the car (single question) | Baseline and 6 months post-enrollment | 
| Change in parentally-reported number of cigarettes smoked | Reported number of cigarettes smoked by parents daily | Baseline and 6 months post-enrollment | 
| Change in parentally-reported child exposure to tobacco smoke, intervention and expanded control groups | Detailed parental report on when and how often child is exposed to tobacco smoke, as summarized by composite scale | Baseline and 6 months post-enrollment | 
| Parental perceptions of risk due to smoking, intervention versus control group | Measurement of risk perceptions resulting in a single composite number using a validated questionnaire | 6 months post-enrollment | 
| Parental perceptions of tobacco smoke exposure, intervention versus control group | Measurement of exposure perceptions resulting in a single composite number using a validated questionnaire | 6 months post-enrollement | 
| Correlations between parentally-reported exposure and child log hair nicotine | Pearson correlations | baseline | 
| Correlations between parentally-reported exposure and child log hair nicotine | Pearson correlations | 6 months |