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Trial record 12 of 24 for:    "secondhand smoke" | Recruiting, Not yet recruiting, Available Studies

An Intervention to Protect Young Children From Tobacco Smoke Exposure

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ClinicalTrials.gov Identifier: NCT02867241
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : October 11, 2017
Sponsor:
Collaborators:
Flight Attendant Medical Research Institute (FAMRI)
Hebrew University
Asaf HaRofeh Hospital
Tel Aviv University
Information provided by (Responsible Party):
Laura J. Rosen, Tel Aviv University

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

Condition or disease Intervention/treatment Phase
Passive Smoking Behavioral: Behavioral Early Behavioral: Behavioral Late Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Intervention to Protect Young Children From Tobacco Smoke Exposure
Study Start Date : August 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Arm Intervention/treatment
Experimental: 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)
Behavioral: Behavioral Early
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))
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

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))
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




Primary Outcome Measures :
  1. Change in child exposure to tobacco smoke as assessed by log hair nicotine [ Time Frame: 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 :
  1. Change in child exposure to tobacco smoke as assessed by parental report [ Time Frame: Baseline and 6 months post-enrollment ]
    Frequency of child exposure to tobacco smoke as measured by a single question

  2. Change in smoking practices in the home as reported by parents [ Time Frame: Baseline and 6 months post-enrollment ]
    Smoking practices in the home as measured by a single question

  3. Change in parental smoking [ Time Frame: Baseline and 6 months post-enrollment ]
    Parental quit rates

  4. Change in parental perceptions of risk due to smoking, intervention and expanded control groups [ Time Frame: Baseline and 6 months post-enrollment ]
    Measurement of risk resulting in a single composite number using a validated questionnaire

  5. Change in parental perceptions of tobacco smoke exposure, intervention and expanded control groups [ Time Frame: Baseline and 6 months post-enrollment ]
    Measurement of exposure perceptions resulting in a single composite number using a validated questionnaire

  6. Child health [ Time Frame: 6 months post-enrollment ]
    Number of child illnesses related to tobacco smoke exposure

  7. Child health services utilization [ Time Frame: 6 months post-enrollment ]
    Number of visits to physicians or emergency care services

  8. Change in smoking practices in the car as reported by parents [ Time Frame: Baseline and 6 months post-enrollment ]
    Frequency of smoking in the car (single question)

  9. Change in parentally-reported number of cigarettes smoked [ Time Frame: Baseline and 6 months post-enrollment ]
    Reported number of cigarettes smoked by parents daily

  10. Change in parentally-reported child exposure to tobacco smoke, intervention and expanded control groups [ Time Frame: 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

  11. Parental perceptions of risk due to smoking, intervention versus control group [ Time Frame: 6 months post-enrollment ]
    Measurement of risk perceptions resulting in a single composite number using a validated questionnaire

  12. Parental perceptions of tobacco smoke exposure, intervention versus control group [ Time Frame: 6 months post-enrollement ]
    Measurement of exposure perceptions resulting in a single composite number using a validated questionnaire

  13. Correlations between parentally-reported exposure and child log hair nicotine [ Time Frame: baseline ]
    Pearson correlations

  14. Correlations between parentally-reported exposure and child log hair nicotine [ Time Frame: 6 months ]
    Pearson correlations



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867241


Contacts
Contact: Laura J Rosen, PhD 972-50-875-1502 rosenl@post.tau.ac.il
Contact: Vicki Myers, MS 972-52-5949544 ext 972-5949544 vicki_myers@hotmail.com

Locations
Israel
Tel Aviv University Recruiting
Ramat Aviv, Israel, 69978
Contact: Nili Brown, BA       nili.chris.brown@gmail.com   
Sponsors and Collaborators
Laura J. Rosen
Flight Attendant Medical Research Institute (FAMRI)
Hebrew University
Asaf HaRofeh Hospital
Tel Aviv University
Investigators
Principal Investigator: Laura J Rosen, PhD Tel Aviv University
Study Director: David M Zucker, PhD Hebrew University

Responsible Party: Laura J. Rosen, Senior Lecturer and Chair, Dept. of Health Promotion, Tel Aviv University
ClinicalTrials.gov Identifier: NCT02867241     History of Changes
Other Study ID Numbers: 0143-16ASF
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No