A Program to Protect Young Children From Tobacco Smoke Exposure

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Tel Aviv University
Sponsor:
Information provided by (Responsible Party):
Laura Rosen, Tel Aviv University
ClinicalTrials.gov Identifier:
NCT01335178
First received: April 12, 2011
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Child Exposure to Tobacco Smoke
Level of Tobacco Smoke in Home
Behavioral: Intervention
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Program to Protect Young Children From Tobacco Smoke Exposure

Resource links provided by NLM:


Further study details as provided by Tel Aviv University:

Primary Outcome Measures:
  • Child exposure to tobacco smoke - hair nicotine [ Time Frame: Baseline, 3 months, post-intervention, 6 months post-intervention ] [ Designated as safety issue: No ]
    Child exposure to tobacco smoke as assessed by hair nicotine level


Secondary Outcome Measures:
  • Child exposure to tobacco smoke - parental report [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]
    Child exposure to tobacco smoke as measured by parental report

  • Child health status [ Time Frame: 6 months post-intervention (continuous) ] [ Designated as safety issue: No ]
    Incidence of respiratory events as reported by parents

  • Respirable Small Particle (RSP) level in home [ Time Frame: Baseline, 1 month, 3 months ] [ Designated as safety issue: No ]
    Measurement of RSPs in the home over a 24-hour period


Estimated Enrollment: 240
Study Start Date: August 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Participants in the Intervention Group will receive the intervention after enrollment in the study.
Behavioral: Intervention
The planned intervention consists of: motivational interviews (in-person and by phone), biochemical feedback on child exposure to tobacco smoke and measurement of RSP levels in the home; and an interactive website.
No Intervention: Control
Participants in the Control Group will receive the intervention after the close of the study.

Detailed Description:

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).

Developmental Stage (Phase I)

This stage includes the following: Systematic reviews of the literature on the topics of encouraging parental cessation and reducing child tobacco smoke exposure; consultations with experts worldwide; conduct of interviews and focus groups with parents and professionals to understand parental perceptions of tobacco smoke exposure, and barriers to protection of children from TSE; development of an initial intervention program; and conduct of design workshops. This stage draws on a social marketing approach and employs in-depth interviews and focus groups in order to identify barriers for behavior change and relevant behavior-change recommendations, tailored to the intervention population, and to test the acceptability of program components.

Intervention Program

The planned intervention consists of: motivational interviews (in-person and by phone), biochemical feedback on child exposure to tobacco smoke and measurement of RSP levels in the home; and an interactive website.

Pilot (Phase II) A pilot of the planned intervention will be conducted with 50-100 families. A before - and - after design will be used, without a control group. The main endpoint is child exposure to tobacco smoke.

Randomized Controlled Trial (Phase III) The investigators plan to implement and evaluate the intervention using a randomized controlled trial with an estimated 240 participants. The primary response variable will be child tobacco smoke exposure. The control group will be offered the intervention at the end of the study (eg, a randomize-to-wait-list design). Child TSE will be measured using hair (nicotine or cotinine) or urinary cotinine , and parental report.

An effective program could be implemented nationally and sustainably in Israel and serve as a prototype for reducing child tobacco smoke exposure.

  Eligibility

Ages Eligible for Study:   2 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

At least one parent is a current smoker. The child is of the appropriate age (2-7 years of age). The child has sufficient hair growth for hair samples. A parent gives consent for participation in the research. The parent can communicate in Hebrew.

Exclusion Criteria:

  • One of above conditions not met
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335178

Contacts
Contact: Laura J Rosen, PhD 972-3-640-5717 rosenl@post.tau.ac.il
Contact: David M Zucker, PhD 972-2-5881291 mszucker@mscc.huji.ac.il

Locations
Israel
Tel Aviv University Recruiting
Ramat Aviv, Israel, 69978
Contact: Laura J Rosen, PhD       rosenl@post.tau.ac.il   
Sub-Investigator: David M Zucker, PhD         
Sub-Investigator: Uri Rubenstein, MD         
Sponsors and Collaborators
Tel Aviv University
Investigators
Principal Investigator: Laura J Rosen, PhD Tel Aviv University
  More Information

Publications:
Responsible Party: Laura Rosen, Chair, Dept. of Health Promotion, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University
ClinicalTrials.gov Identifier: NCT01335178     History of Changes
Other Study ID Numbers: FAMRI-072086_YCSA
Study First Received: April 12, 2011
Last Updated: December 6, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Tel Aviv University:
Tobacco smoke exposure
Secondhand smoke exposure
Passive smoking
Child health
Randomized controlled trial
Prevention
Tobacco control
Motivational Interviewing

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on July 29, 2014