A Program to Protect Young Children From Tobacco Smoke Exposure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laura Rosen, Tel Aviv University
ClinicalTrials.gov Identifier:
NCT01335178
First received: April 12, 2011
Last updated: December 8, 2015
Last verified: November 2015
  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
Behavioral: Intervention
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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, 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: Baseline, 6 months post-intervention ] [ Designated as safety issue: No ]
    Child exposure to tobacco smoke as measured by parental report

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

  • Respirable Small Particle (RSPs - PM2.5) level in home [ Time Frame: Baseline, 1 month post-intervention ] [ Designated as safety issue: No ]
    Measurement of RSPs in the home over a 24-hour period

  • Air nicotine [ Time Frame: Baseline, 6 months post-intervention ] [ Designated as safety issue: No ]
    Passive nicotine dosimeters were used for 1 7-day period in the home


Enrollment: 29
Study Start Date: January 2013
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention
Participants received the behavioral intervention, which was designed to motivate parents to protect their children from tobacco smoke exposure
Behavioral: Intervention
The intervention consisted of the following elements: (a) Three motivational interviews, scheduled for baseline, one month, and three months; (b) Feedback on air quality in the home (PM2.5 was measured using a Sidepak and/or a Dylos monitoring device, and air nicotine was measured using passive air nicotine dosimeters); (c) Feedback on child's exposure via hair nicotine; (d) a website designed especially for the project [parents.org.il];and (e) various self-help materials, including a booklet, a magnet about TSE, and air fresheners.

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). This registration pertains to Phase II of this trial.

Developmental Stage (Phase I)

This stage includes the following: Systematic reviews of the literature on the topics of encouraging i. parental cessation, ii.reducing child tobacco smoke exposure (TSE), and iii.reducing tobacco smoke air pollution in homes; consultations with experts worldwide; conduct of interviews with parents (n=65) and professionals (n=15) to understand parental perceptions of tobacco smoke exposure, and barriers to protection of children from TSE; and development of an initial intervention program. This stage draws on a social marketing approach and employs in-depth interviews to identify barriers to behavior change and relevant behavior-change recommendations, tailored to the intervention population, and to test the acceptability of program components.

Intervention Program

The intervention consisted of the following elements: (a) Three motivational interviews, scheduled for baseline, one month, and three months; (b) Feedback on air quality in the home (from a Sidepak and/or a Dylos monitoring device, and from passive air nicotine dosimeters); (c) Feedback on child's exposure via hair samples analyzed for nicotine; (d) a website designed especially for the project [22];and (e) various self-help materials, including a booklet, a magnet about TSE, and air fresheners.

Pilot (Phase II) A pilot of the planned intervention was conducted with 29 families. A before - and - after design was used, without a control group. The main endpoint was child exposure to tobacco smoke as measured by hair nicotine. Secondary endpoints included child exposure to tobacco smoke as measured by parental reports, family smoking in home or car, home air nicotine, child illnesses, and use of health services.

[Randomized Controlled Trial (Phase III) (Note: a separate registration number is being sought for this phase) The investigators plan to implement and evaluate the intervention using a randomized controlled trial with an estimated 120 participants. The primary response variable will be child tobacco smoke exposure as measured by hair nicotine. The control group will be offered the intervention at the end of the study (eg, a randomize-to-wait-list design). ]

An effective program for child tobacco smoke exposure reduction could serve as a prototype for reducing child tobacco smoke exposure.

  Eligibility

Ages Eligible for Study:   up to 8 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

At least one parent was a current smoker. The child was of the appropriate age (<8 years of age). The child had sufficient hair growth for hair samples. A parent gave 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

Locations
Israel
Tel Aviv University
Ramat Aviv, Israel, 69978
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 8, 2015
Health Authority: Israel: Ministry of Health

Keywords provided by Tel Aviv University:
Tobacco smoke exposure
Secondhand smoke exposure
Passive smoking
Child health
Prevention
Tobacco control
Motivational Interviewing
Air quality
Pilot Study

ClinicalTrials.gov processed this record on August 25, 2016