An Intervention to Protect Young Children From Tobacco Smoke Exposure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Passive Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

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)

Group Type EXPERIMENTAL

Behavioral Early

Intervention Type BEHAVIORAL

Participants will receive an intervention which includes motivational interviewing, biochemical feedback, air quality feedback, phone calls, and social media

Control Regular

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))

Group Type OTHER

Behavioral Late

Intervention Type 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

Control Expanded

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))

Group Type OTHER

Behavioral Late

Intervention Type 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

Interventions

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Behavioral Early

Participants will receive an intervention which includes motivational interviewing, biochemical feedback, air quality feedback, phone calls, and social media

Intervention Type BEHAVIORAL

Behavioral Late

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. \- Families in which at least one parent smokes, and both parents combined smoke a minimum of 10 cigarettes per week
2. \- Parents willing to provide child hair samples
3. \- Hebrew speaking participants
4. \- Parents are willing to participate from time of entry for the coming 8 months .