A Program to Protect Young Children From Tobacco Smoke Exposure
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|ClinicalTrials.gov Identifier: NCT01335178|
Recruitment Status : Completed
First Posted : April 14, 2011
Last Update Posted : December 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Child Exposure to Tobacco Smoke||Behavioral: Intervention||Phase 2|
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.
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 ;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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Program to Protect Young Children From Tobacco Smoke Exposure|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Participants received the behavioral intervention, which was designed to motivate parents to protect their children from tobacco smoke exposure
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.
- Child exposure to tobacco smoke - hair nicotine [ Time Frame: Baseline, 6 months post-intervention ]Child exposure to tobacco smoke as assessed by hair nicotine level
- Child exposure to tobacco smoke - parental report [ Time Frame: Baseline, 6 months post-intervention ]Child exposure to tobacco smoke as measured by parental report
- Child health status [ Time Frame: Baseline, 6 months post-intervention (continuous) ]Incidence of respiratory events as reported by parents
- Respirable Small Particle (RSPs - PM2.5) level in home [ Time Frame: Baseline, 1 month post-intervention ]Measurement of RSPs in the home over a 24-hour period
- Air nicotine [ Time Frame: Baseline, 6 months post-intervention ]Passive nicotine dosimeters were used for 1 7-day period in the home
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335178
|Tel Aviv University|
|Ramat Aviv, Israel, 69978|
|Principal Investigator:||Laura J Rosen, PhD||Tel Aviv University|