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Passive SmokingPhase 3NCT02867241

An Intervention to Protect Young Children From Tobacco Smoke Exposure

A Phase 3 study testing Behavioral Early and Behavioral Late in people with Passive Smoking, run by Laura J. Rosen at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages Up to 8 yearsHealthy volunteers can take part
Conditions the study is for
Passive Smoking
What is being tested?
Behavioral Early and Behavioral Late
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteIsrael
Study dates
Aug 2016to Dec 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • There are no additional exclusion criteria
  • -

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Tel Aviv University

    Ramat Aviv, 69978

Other trials in Israel

About this study

The primary goal of this research is to evaluate the effectiveness of an intervention for parents to reduce tobacco smoke exposure of young children

Read the 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.

Conditions
Passive Smoking
Being tested
Behavioral Early, Behavioral Late

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral EarlyBehavioural

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

  • Behavioral LateBehavioural

    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

Study groups in NCT02867241
Study groupRoleWhat they receive
InterventionExperimental1. 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)
Receives: Behavioral: Behavioral Early
Control RegularOtherThis 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))
Receives: Behavioral: Behavioral Late
Control ExpandedOtherThis 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))
Receives: Behavioral: Behavioral Late

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline and 6 months post-enrollment

Secondary outcomes (14)

  1. 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

    Measured: Baseline and 6 months post-enrollment

  2. Change in smoking practices in the home as reported by parents

    Smoking practices in the home as measured by a single question

    Measured: Baseline and 6 months post-enrollment

  3. Change in parental smoking

    Parental quit rates

    Measured: Baseline and 6 months post-enrollment

  4. 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

    Measured: Baseline and 6 months post-enrollment

  5. 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

    Measured: Baseline and 6 months post-enrollment

  6. Child health

    Number of child illnesses related to tobacco smoke exposure

    Measured: 6 months post-enrollment

  7. Child health services utilization

    Number of visits to physicians or emergency care services

    Measured: 6 months post-enrollment

  8. Change in smoking practices in the car as reported by parents

    Frequency of smoking in the car (single question)

    Measured: Baseline and 6 months post-enrollment

  9. Change in parentally-reported number of cigarettes smoked

    Reported number of cigarettes smoked by parents daily

    Measured: Baseline and 6 months post-enrollment

  10. 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

    Measured: Baseline and 6 months post-enrollment

  11. 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

    Measured: 6 months post-enrollment

  12. Parental perceptions of tobacco smoke exposure, intervention versus control group

    Measurement of exposure perceptions resulting in a single composite number using a validated questionnaire

    Measured: 6 months post-enrollement

  13. Correlations between parentally-reported exposure and child log hair nicotine

    Pearson correlations

    Measured: baseline

  14. Correlations between parentally-reported exposure and child log hair nicotine

    Pearson correlations

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionJul 2018
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02867241
Sponsor's protocol ID
0143-16ASF
Status last verified
Aug 2018
First submitted
4 Aug 2016
Last updated
17 Aug 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34021353

  • 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.

    PubMed 32408551

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Behavioral Early and Behavioral Late in people with Passive Smoking, run by Laura J. Rosen at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in child exposure to tobacco smoke as assessed by log hair nicotine (time frame: Baseline and 6 months post-enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02867241, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.

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