An Intervention to Protect Young Children From Tobacco Smoke Exposure

Passive Smoking Clinical Trial

Official title:

An Intervention to Protect Young Children From Tobacco Smoke Exposure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02867241
• Other study ID #: 0143-16ASF
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2018
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 8 Years

Eligibility

Inclusion Criteria for RCT :

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 .

Exclusion Criteria:

There are no additional exclusion criteria

Related Conditions & MeSH terms

• Passive Smoking

Intervention

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

Locations

Country	Name	City	State
Israel	Tel Aviv University	Ramat Aviv

Sponsors (5)

Lead Sponsor	Collaborator
Laura J. Rosen	Asaf HaRofeh Hospital, Flight Attendant Medical Research Institute (FAMRI), Hebrew University, Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Change in smoking practices in the home as reported by parents	Smoking practices in the home as measured by a single question	Baseline and 6 months post-enrollment
Secondary	Change in parental smoking	Parental quit rates	Baseline and 6 months post-enrollment
Secondary	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
Secondary	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
Secondary	Child health	Number of child illnesses related to tobacco smoke exposure	6 months post-enrollment
Secondary	Child health services utilization	Number of visits to physicians or emergency care services	6 months post-enrollment
Secondary	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
Secondary	Change in parentally-reported number of cigarettes smoked	Reported number of cigarettes smoked by parents daily	Baseline and 6 months post-enrollment
Secondary	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
Secondary	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
Secondary	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
Secondary	Correlations between parentally-reported exposure and child log hair nicotine	Pearson correlations	baseline
Secondary	Correlations between parentally-reported exposure and child log hair nicotine	Pearson correlations	6 months