A Program to Protect Young Children From Tobacco Smoke Exposure
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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 |
- 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
- 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 |
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| 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 |
| 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 | |
| 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 June 17, 2013