An Intervention to Protect Young Children From Tobacco Smoke Exposure

Phase 3

• Conditions: Passive Smoking

• Registration Number: NCT02867241
• Lead Sponsor: Laura J. Rosen

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 Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-11
• Study First Posted: 2016-08-15
• Primary Completion: 2018-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-17
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

There are no additional exclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Child health services utilization	6 months post-enrollment	Number of visits to physicians or emergency care services
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
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
Change in parentally-reported number of cigarettes smoked	Baseline and 6 months post-enrollment	Reported number of cigarettes smoked by parents daily
Correlations between parentally-reported exposure and child log hair nicotine	6 months	Pearson correlations
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 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
Child health	6 months post-enrollment	Number of child illnesses related to tobacco smoke exposure
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 parental smoking	Baseline and 6 months post-enrollment	Parental quit rates
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)

Trial Locations

Locations (1)

Tel Aviv University; 🇮🇱 Ramat Aviv, Israel