ClinicalTrials.gg
CompletedNCT00683228Updated Dec 2, 2014

Effect of Using a Structured Tobacco Cessation Education Program

An interventional study of Counseling in Secondhand Smoke Exposure, sponsored by State University of New York - Upstate Medical University. Completed at 1 site in United States. Open to participants aged 1 Day to 15 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-02.

Sponsored by State University of New York - Upstate Medical University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
1 Day to 15 Days
Sex
All
01

Study summary

This is a pilot study that aims to

  1. Evaluate the effectiveness of using a structured tobacco cessation education program, CEASE (Clinical effort against second hand smoke exposure), NY, delivered by pediatric residents in the outpatient continuity clinic of the pediatric residency program in reducing the exposure of infants to second hand smoke.
  2. Evaluate the efficacy of using a second hand smoke exposure biomarker, Urine cotinine level measurement and feedback as an adjunct to counseling.
Read the detailed description

The WHO estimates that half the children in the world are exposed to secondhand smoke. Despite recent smoke free legislation across the country, an estimated 22 percent of children are still exposed in their home environments. These children have increased rates of lower respiratory illnesses, middle ear effusion, asthma, reduced lung function and SIDS. This study aims to evaluate the effectiveness of using a structured tobacco cessation education program, CEASE (Clinical Effort against Secondhand Smoke Exposure), delivered by pediatric residents in the outpatient continuity clinic of a pediatric residency program in reducing the exposure of infants to secondhand smoke. It will also evaluate the efficacy of using a secondhand smoke biomarker, urine cotinine level measurement and feedback as an adjunct to counseling.

Residents(and faculty) whose continuity clinic will be doing the intervention will be receiving tailored training on CEASE NY. The control continuity residents and faculty will receive no additional training. Pre and Post test questionnaires will be administered to all residents of both continuity clinics to test effectiveness of the teaching intervention and use of cotinine level on knowledge and practice. Consecutive newborns with a history of smoking in their home will be recruited into the study ( 22 in each group) when they first establish care ( between days 3 and 15), using a screening question on the nurses portion of the well child form. The study coordinator will obtain consent for participation from those screening positive for smoking in the home. Once consent is obtained the newborns will be randomly assigned to either intervention or control group by the study coordinator. The intervention group will be assigned to a CEASE trained resident for follow-up continuity care. The controls will be assigned to a non- CEASE trained resident for follow-up care. The study coordinator will log the date, agreement/non-agreement to participate, and who the caregiver is (parent vs. other) and to what group they have been assigned, giving them a unique study number. To account for the possibility of dropout, we will recruit 22 infants into each group. Baseline urine samples will be obtained for both groups. The intervention group will receive specific CEASE materials (see attached) and counseling at 2, 4, 6, month well child visits and urine for cotinine will be obtained at 4 and 9 months. Intervention parents will be given feedback on the urine cotinine levels at the next well child visit. The control group will receive no intervention at 2, 4, 6 months. A urine cotinine level will be obtained and a follow-up questionnaire will be given at the 9 month visit to both group parents evaluating their readiness to quit/cut down smoking and their subjective perception of the efficacy of resident counseling.

Baseline urine samples will be obtained for both groups. The intervention group will receive specific CEASE materials (see attached) and counseling at 2, 4, 6, month well child visits and urine for cotinine will be obtained at 4 and 9 months. Intervention parents will be given feedback on the urine cotinine levels at the next well child visit. Control Group will receive no intervention at 2, 4, 6 months. A urine cotinine level will be obtained and a follow-up questionnaire will be given at the 9 month visit to both group parents evaluating their readiness to quit/cut down smoking and their subjective perception of the efficacy of resident counseling. All children will receive a small age-appropriate toy at the 12 month well child check as a thank you for participating in the study

02

Conditions studied

  • Secondhand Smoke Exposure

Keywords

  • Second hand Smoke
03

In context

Lead sponsor

State University of New York - Upstate Medical University is the lead sponsor of 156 studies on the registry; 17 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 4 (36%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 15 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Newborn infants up to 15 days of age

Exclusion criteria

Exclusion Criteria:

  • Non English speaking family and infants with significant medical problems at birth needing NICU stay
  • foster children and wards of state
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • Other
    Counseling

    some caregivers will be provided counseling related to the hazards of secondhand smoke exposure

    Behavioral: Counseling

Interventions

  • BehavioralCounseling

    Consecutive newborns exposed to secondhand smoke will be recruited into the study and randomized to have parents receive or not receive specific counselling on harmful effects of SHS exposure. Urine cotinine will be measured at several points during the study for each group

06

What researchers measure

Primary outcomes

  1. Evaluate the effectiveness of using a structured tobacco cessation education program, CEASE,delivered by pediatric residents in the outpatient continuity clinic of the pediatric residency program in reducing the exposure of infants to second hand smoke.

    Time frame: Begining of study and at completion of study

Secondary outcomes

  1. Evaluate the efficacy of using a second hand smoke exposure biomarker, Urine cotinine level measurement and feedback as an adjunct to counseling

    Time frame: first visit, 4 month visit, 9 month visit

07

Study locations

1 site
  • SUNY Upstate Medical University
    Syracuse, New York 13210, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00683228
Responsible party
Donna Bacchi (Principal Investigator, State University of New York - Upstate Medical University) — Principal investigator
First posted
May 23, 2008
Start date
Oct 2007
Primary completion
Jun 2009
Completion
Jun 2009
Last update
Dec 2, 2014

Study contacts

Donna Bacchi, Md
principal investigator · State University of New York - Upstate Medical University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion