An Intervention to Protect Young Children From Tobacco Smoke Exposure

The primary goal of this research is to evaluate the effectiveness of an intervention for parents to reduce tobacco smoke exposure of young children

Study Overview

• Status: Unknown
• Conditions: Passive Smoking
• Intervention / Treatment: Behavioral: Behavioral Early; Behavioral: Behavioral Late

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 3

Contacts and Locations

Study Locations

• Israel
  • Ramat Aviv, Israel, 69978
    • Tel Aviv University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 exclusion criteria

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; Participants will receive an intervention which includes motivational interviewing, biochemical feedback, air quality feedback, phone calls, and social media
Other: Control Regular; 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; 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
Other: Control Expanded; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Laura J. Rosen
• Collaborators: Tel Aviv University; Flight Attendant Medical Research Institute (FAMRI); Hebrew University; Asaf HaRofeh Hospital
• Investigators: Principal Investigator: Laura J Rosen, PhD, Tel Aviv University; Study Director: David M Zucker, PhD, Hebrew University

Publications and helpful links

General Publications

• Rosen L, Zucker D, Guttman N, Brown N, Bitan M, Rule A, Berkovitch M, Myers V. Protecting Children From Tobacco Smoke Exposure: A Randomized Controlled Trial of Project Zero Exposure. Nicotine Tob Res. 2021 Nov 5;23(12):2003-2012. doi: 10.1093/ntr/ntab106.
• Myers V, Shiloh S, Zucker DM, Rosen LJ. Changing Exposure Perceptions: A Randomized Controlled Trial of an Intervention with Smoking Parents. Int J Environ Res Public Health. 2020 May 12;17(10):3349. doi: 10.3390/ijerph17103349.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: August 4, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (Estimate): August 15, 2016

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 0143-16ASF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No