An Intervention to Protect Young Children From Tobacco Smoke Exposure

NCT02867241 | Unknown Phase 3

• 1 other identifier: 0143-16ASF
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Passive Smoking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Change in child exposure to tobacco smoke as assessed by parental report

  Baseline and 6 months post-enrollment

• Change in smoking practices in the home as reported by parents

  Baseline and 6 months post-enrollment

• Change in parental smoking

  Baseline and 6 months post-enrollment

• Change in parental perceptions of risk due to smoking, intervention and expanded control groups

  Baseline and 6 months post-enrollment

• Change in parental perceptions of tobacco smoke exposure, intervention and expanded control groups

  Baseline and 6 months post-enrollment

Study Arms (3)

Intervention

EXPERIMENTAL

1. Motivational interviews (3 visits) + supportive phone calls 2. Feedback of child hair nicotine levels 3. Feedback of home air quality (PM2.5) 4. New Media (Website and/or Facebook with information and parental forum)

Behavioral: Behavioral Early

Control Regular

OTHER

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

Control Expanded

OTHER

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

Interventions

Behavioral Early BEHAVIORAL

Participants will receive an intervention which includes motivational interviewing, biochemical feedback, air quality feedback, phone calls, and social media

Intervention

Behavioral Late BEHAVIORAL

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

Control Expanded; Control Regular

Eligibility Criteria

• Age: Up to 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- 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 .

Sponsors & Collaborators

• Laura J. Rosen: lead
• Flight Attendant Medical Research Institute (FAMRI): collaborator
• Hebrew University: collaborator
• Assaf-Harofeh Medical Center: collaborator
• Tel Aviv University: collaborator

Study Sites (1)

Tel Aviv University

Ramat Aviv, 69978, Israel

Location

Related Publications (2)

• 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.

  PMID: 34021353 DERIVED

• 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.

  PMID: 32408551 DERIVED

Study Officials

• Laura J Rosen, PhD

  Tel Aviv University

  PRINCIPAL INVESTIGATOR

• David M Zucker, PhD

  Hebrew University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Lecturer and Chair, Dept. of Health Promotion

Study Record Dates

• First Submitted: August 4, 2016
• First Posted: August 15, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)