An Intervention to Protect Young Children From Tobacco Smoke Exposure
- Conditions
- Passive Smoking
- Interventions
- Behavioral: Behavioral LateBehavioral: Behavioral Early
- Registration Number
- NCT02867241
- Lead Sponsor
- Laura J. Rosen
- Brief Summary
The primary goal of this research is to evaluate the effectiveness of an intervention for parents to reduce tobacco smoke exposure of young children
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
Not provided
There are no additional exclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Expanded Behavioral Late 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)) Control Regular Behavioral Late 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)) Intervention Behavioral Early 1. Motivational interviews (3 visits) + supportive phone calls 2. Feedback of child hair nicotine levels 3. Feedback of home air quality (PM2.5) 4. New Media (Website and/or Facebook with information and parental forum)
- Primary Outcome Measures
Name Time Method Change in child exposure to tobacco smoke as assessed by log hair nicotine Baseline and 6 months post-enrollment A small amount of hair will be taken from the child's head near the scalp and sent to a laboratory for analysis
- Secondary Outcome Measures
Name Time Method Change in smoking practices in the car as reported by parents Baseline and 6 months post-enrollment Frequency of smoking in the car (single question)
Child health services utilization 6 months post-enrollment Number of visits to physicians or emergency care services
Change in parentally-reported child exposure to tobacco smoke, intervention and expanded control groups Baseline and 6 months post-enrollment Detailed parental report on when and how often child is exposed to tobacco smoke, as summarized by composite scale
Parental perceptions of risk due to smoking, intervention versus control group 6 months post-enrollment Measurement of risk perceptions resulting in a single composite number using a validated questionnaire
Parental perceptions of tobacco smoke exposure, intervention versus control group 6 months post-enrollement Measurement of exposure perceptions resulting in a single composite number using a validated questionnaire
Change in parental perceptions of tobacco smoke exposure, intervention and expanded control groups Baseline and 6 months post-enrollment Measurement of exposure perceptions resulting in a single composite number using a validated questionnaire
Change in parentally-reported number of cigarettes smoked Baseline and 6 months post-enrollment Reported number of cigarettes smoked by parents daily
Correlations between parentally-reported exposure and child log hair nicotine 6 months Pearson correlations
Change in smoking practices in the home as reported by parents Baseline and 6 months post-enrollment Smoking practices in the home as measured by a single question
Change in parental perceptions of risk due to smoking, intervention and expanded control groups Baseline and 6 months post-enrollment Measurement of risk resulting in a single composite number using a validated questionnaire
Child health 6 months post-enrollment Number of child illnesses related to tobacco smoke exposure
Change in child exposure to tobacco smoke as assessed by parental report Baseline and 6 months post-enrollment Frequency of child exposure to tobacco smoke as measured by a single question
Change in parental smoking Baseline and 6 months post-enrollment Parental quit rates
Trial Locations
- Locations (1)
Tel Aviv University
🇮🇱Ramat Aviv, Israel