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| Name | Class |
|---|---|
| Flight Attendant Medical Research Institute (FAMRI) | UNKNOWN |
| Hebrew University | UNKNOWN |
| Assaf-Harofeh Medical Center | OTHER_GOV |
| Tel Aviv University |
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The primary goal of this research is to evaluate the effectiveness of an intervention for parents to reduce tobacco smoke exposure of young children
The primary aim of this intervention is to reduce exposure of children to tobacco smoke, through an intervention program designed to help parents better perceive exposure and its harms, and to provide tools for assisting them in protecting children. Secondary aims are to understand the relationships between parentally-reported and objectively measured child tobacco smoke exposure, to assess the relationship between tobacco smoke exposure and health and health care utilization, and to better understand parental perceptions of tobacco smoke exposure (PPE) and parental perceptions of risk (PPR) from tobacco smoke exposure. The effectiveness of the intervention will be evaluated using a randomized controlled trial.
This RCT is a continuation of previous work. Originally the entire research project, which included a Pilot Study and a Randomized Controlled Trial (RCT) was registered as NCT01335178. Upon completion of the Pilot Study, we closed NCT01335178 and opened a new one for the RCT with the current registration number.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental |
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| 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)) |
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| 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)) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Early | Behavioral | Participants will receive an intervention which includes motivational interviewing, biochemical feedback, air quality feedback, phone calls, and social media |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in child exposure to tobacco smoke as assessed by parental report | Frequency of child exposure to tobacco smoke as measured by a single question | Baseline and 6 months post-enrollment |
| Change in smoking practices in the home as reported by parents |
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Inclusion Criteria for RCT :
Exclusion Criteria:
There are no additional exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Laura J Rosen, PhD | Tel Aviv University | Principal Investigator |
| David M Zucker, PhD | Hebrew University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv University | Ramat Aviv | 69978 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34021353 | Derived | 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. | |
| 32408551 | 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. |
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| OTHER |
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| 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 |
|
Smoking practices in the home as measured by a single question |
| Baseline and 6 months post-enrollment |
| Change in parental smoking | Parental quit rates | Baseline and 6 months post-enrollment |
| Change in parental perceptions of risk due to smoking, intervention and expanded control groups | Measurement of risk resulting in a single composite number using a validated questionnaire | Baseline and 6 months post-enrollment |
| Change in parental perceptions of tobacco smoke exposure, intervention and expanded control groups | Measurement of exposure perceptions resulting in a single composite number using a validated questionnaire | Baseline and 6 months post-enrollment |
| Child health | Number of child illnesses related to tobacco smoke exposure | 6 months post-enrollment |
| Child health services utilization | Number of visits to physicians or emergency care services | 6 months post-enrollment |
| Change in smoking practices in the car as reported by parents | Frequency of smoking in the car (single question) | Baseline and 6 months post-enrollment |
| Change in parentally-reported number of cigarettes smoked | Reported number of cigarettes smoked by parents daily | Baseline and 6 months post-enrollment |
| Change in parentally-reported child exposure to tobacco smoke, intervention and expanded control groups | Detailed parental report on when and how often child is exposed to tobacco smoke, as summarized by composite scale | Baseline and 6 months post-enrollment |
| Parental perceptions of risk due to smoking, intervention versus control group | Measurement of risk perceptions resulting in a single composite number using a validated questionnaire | 6 months post-enrollment |
| Parental perceptions of tobacco smoke exposure, intervention versus control group | Measurement of exposure perceptions resulting in a single composite number using a validated questionnaire | 6 months post-enrollement |
| Correlations between parentally-reported exposure and child log hair nicotine | Pearson correlations | baseline |
| Correlations between parentally-reported exposure and child log hair nicotine | Pearson correlations | 6 months |