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Child Exposure to Tobacco SmokePhase 2NCT01335178

A Program to Protect Young Children From Tobacco Smoke Exposure

A Phase 2 study testing Intervention in people with Child Exposure to Tobacco Smoke, run by Tel Aviv University at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this research project is to develop and evaluate an intervention to reduce young child tobacco smoke exposure Read more about this study

Who is it for?
Ages Up to 8 yearsHealthy volunteers can take part
Conditions the study is for
Child Exposure to Tobacco Smoke
What is being tested?
Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteIsrael
Study dates
Jan 2013to Sep 2015
Phase
Phase 2
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

  • At least one parent was a current smoker. The child was of the appropriate age (<8 years of age). The child had sufficient hair growth for hair samples. A parent gave consent for participation in the research. The parent can communicate in Hebrew.

Who cannot join

  • One of above conditions not met

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Tel Aviv University

    Ramat Aviv, Israel, 69978

Other trials in Israel

About this study

The goal of this research project is to develop and evaluate an intervention to reduce young child tobacco smoke exposure

Read the detailed description

Goals The primary goal of this research is to develop and test a theory-based intervention which will reduce tobacco smoke exposure (TSE) of young children. A secondary goal is to increase knowledge of measurement of TSE in young children, and explore the relationship between early TSE, illness, and health care utilization. The study is being conducted in several stages: Developmental (Phase I), Pilot (Phase II), and Trial (Phase III). This registration pertains to Phase II of this trial.

Developmental Stage (Phase I)

This stage includes the following: Systematic reviews of the literature on the topics of encouraging i. parental cessation, ii.reducing child tobacco smoke exposure (TSE), and iii.reducing tobacco smoke air pollution in homes; consultations with experts worldwide; conduct of interviews with parents (n=65) and professionals (n=15) to understand parental perceptions of tobacco smoke exposure, and barriers to protection of children from TSE; and development of an initial intervention program. This stage draws on a social marketing approach and employs in-depth interviews to identify barriers to behavior change and relevant behavior-change recommendations, tailored to the intervention population, and to test the acceptability of program components.

Intervention Program

The intervention consisted of the following elements: (a) Three motivational interviews, scheduled for baseline, one month, and three months; (b) Feedback on air quality in the home (from a Sidepak and/or a Dylos monitoring device, and from passive air nicotine dosimeters); (c) Feedback on child's exposure via hair samples analyzed for nicotine; (d) a website designed especially for the project [22];and (e) various self-help materials, including a booklet, a magnet about TSE, and air fresheners.

Pilot (Phase II) A pilot of the planned intervention was conducted with 29 families. A before - and - after design was used, without a control group. The main endpoint was child exposure to tobacco smoke as measured by hair nicotine. Secondary endpoints included child exposure to tobacco smoke as measured by parental reports, family smoking in home or car, home air nicotine, child illnesses, and use of health services.

[Randomized Controlled Trial (Phase III) (Note: a separate registration number is being sought for this phase) The investigators plan to implement and evaluate the intervention using a randomized controlled trial with an estimated 120 participants. The primary response variable will be child tobacco smoke exposure as measured by hair nicotine. The control group will be offered the intervention at the end of the study (eg, a randomize-to-wait-list design). ]

An effective program for child tobacco smoke exposure reduction could serve as a prototype for reducing child tobacco smoke exposure.

Being tested
Intervention
Keywords
Tobacco smoke exposure, Secondhand smoke exposure, Passive smoking, Child health, Prevention, Tobacco control, Motivational Interviewing, Air quality, Pilot Study

What participants receive

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

  • InterventionBehavioural

    The intervention consisted of the following elements: (a) Three motivational interviews, scheduled for baseline, one month, and three months; (b) Feedback on air quality in the home (PM2.5 was measured using a Sidepak and/or a Dylos monitoring device, and air nicotine was measured using passive air nicotine dosimeters); (c) Feedback on child's exposure via hair nicotine; (d) a website designed especially for the project [parents.org.il];and (e) various self-help materials, including a booklet, a magnet about TSE, and air fresheners.

Study groups in NCT01335178
Study groupRoleWhat they receive
InterventionExperimentalParticipants received the behavioral intervention, which was designed to motivate parents to protect their children from tobacco smoke exposure
Receives: Behavioral: Intervention

What is being measured

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

  1. Child exposure to tobacco smoke - hair nicotine

    Child exposure to tobacco smoke as assessed by hair nicotine level

    Measured: Baseline, 6 months post-intervention

Secondary outcomes (4)

  1. Child exposure to tobacco smoke - parental report

    Child exposure to tobacco smoke as measured by parental report

    Measured: Baseline, 6 months post-intervention

  2. Child health status

    Incidence of respiratory events as reported by parents

    Measured: Baseline, 6 months post-intervention (continuous)

  3. Respirable Small Particle (RSPs - PM2.5) level in home

    Measurement of RSPs in the home over a 24-hour period

    Measured: Baseline, 1 month post-intervention

  4. Air nicotine

    Passive nicotine dosimeters were used for 1 7-day period in the home

    Measured: Baseline, 6 months post-intervention

Timeline

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

  1. First posted14 Apr 2011 (estimated)
  2. Study startJan 2013
  3. Primary completionSep 2015
  4. Study completionSep 2015

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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01335178
Sponsor's protocol ID
FAMRI-072086_YCSA
Status last verified
Nov 2015
First submitted
12 Apr 2011
Last updated
9 Dec 2015
Results posted
No
Data monitoring committee
No

Publications

  • Rosen LJ, Guttman N, Hovell MF, Noach MB, Winickoff JP, Tchernokovski S, Rosenblum JK, Rubenstein U, Seidmann V, Vardavas CI, Klepeis NE, Zucker DM. Development, design, and conceptual issues of project zero exposure: A program to protect young children from tobacco smoke exposure. BMC Public Health. 2011 Jun 28;11:508. doi: 10.1186/1471-2458-11-508.

    PubMed 21711530

  • Rosen LJ, Noach MB, Winickoff JP, Hovell MF. Parental smoking cessation to protect young children: a systematic review and meta-analysis. Pediatrics. 2012 Jan;129(1):141-52. doi: 10.1542/peds.2010-3209. Epub 2011 Dec 26.

    PubMed 22201152

  • Rosen LJ, Myers V, Hovell M, Zucker D, Ben Noach M. Meta-analysis of parental protection of children from tobacco smoke exposure. Pediatrics. 2014 Apr;133(4):698-714. doi: 10.1542/peds.2013-0958. Epub 2014 Mar 24.

    PubMed 24664094

  • Rosen LJ, Tillinger E, Guttman N, Rosenblat S, Zucker DM, Stillman F, Myers V. Parental receptivity to child biomarker testing for tobacco smoke exposure: A qualitative study. Patient Educ Couns. 2015 Nov;98(11):1439-45. doi: 10.1016/j.pec.2015.05.023. Epub 2015 Jun 9.

    PubMed 26160037

  • Rosen L, Zucker D, Hovell M, Brown N, Ram A, Myers V. Feasibility of Measuring Tobacco Smoke Air Pollution in Homes: Report from a Pilot Study. Int J Environ Res Public Health. 2015 Nov 30;12(12):15129-42. doi: 10.3390/ijerph121214970.

    PubMed 26633440

  • Rosen L, Guttman N, Myers V, Brown N, Ram A, Hovell M, Breysse P, Rule A, Berkovitch M, Zucker D. Protecting Young Children From Tobacco Smoke Exposure: A Pilot Study of Project Zero Exposure. Pediatrics. 2018 Jan;141(Suppl 1):S107-S117. doi: 10.1542/peds.2017-1026N.

    PubMed 29292311

  • Rosen LJ, Lev E, Guttman N, Tillinger E, Rosenblat S, Zucker DM, Myers V. Parental Perceptions and Misconceptions of Child Tobacco Smoke Exposure. Nicotine Tob Res. 2018 Sep 25;20(11):1369-1377. doi: 10.1093/ntr/ntx169.

    PubMed 29059387

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intervention in people with Child Exposure to Tobacco Smoke, run by Tel Aviv University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Dec 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Child exposure to tobacco smoke - hair nicotine (time frame: Baseline, 6 months post-intervention). 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 NCT01335178, which also lists 7 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 9 Dec 2015.

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