Brief Title
A Study of Tobacco Smoke and Children With Respiratory Illnesses
Official Title
Urine Cotinine in Children and Parental Behavior Modification: A Pilot Study
Brief Summary
This study aims to assess the feasibility of using an intervention for environmental smoke
exposure in children that uses cotinine testing results with written materials and telephone
counseling for a potential future study of parents whose children are admitted with
respiratory illnesses to The Barbara Bush Children's Hospital in Portland, Maine.
Detailed Description
Children who are regularly exposed to environmental tobacco smoke (ETS) are at a greater risk
for developing respiratory disease. Given the strong relationship between parental smoking
and child health, many studies have evaluated the efficacy of interventions to modify
parental smoking behavior and thereby reduce children's exposure to second- and thirdhand
tobacco smoke, including the use of cotinine levels in children. There are several local ETS
exposure intervention programs for The Barbara Bush Children's Hospital patient population
and their families. The state of Maine and MaineHealth fund a free 24-hour tobacco cessation
hotline (The Maine Tobacco Helpline) which combines evidence-based behavioral counseling
techniques and free nicotine replacement therapy (gum, lozenge, or patch). MaineHealth also
runs a tobacco cessation campaign (The Breathe Easy Coalition) that provides print materials
and trainings aimed to reduce smoking in public housing, hospitals, behavioral health
facilities, and higher education. The Breathe Easy Coalition's Smoke-Free Housing program
provides education about the effects of secondhand and thirdhand tobacco smoke and asks
families to pledge to keep tobacco smoke out of their home. This study aims to combine all
three of these strategies (child cotinine feedback, tobacco cessation counseling, and written
materials on ETS) to create a cohesive ETS exposure reduction program for the Barbara Bush
Children's Hospital inpatient population, and determine the feasibility of a future study
that would evaluate whether cotinine testing is helpful for changing smoking behaviors in
this target population.
Study Type
Interventional
Primary Outcome
Rate of acceptance of a smoking cessation intervention
Secondary Outcome
Rate of positive urine cotinine in children admitted with positive tobacco smoke exposure history.
Condition
Bronchiolitis
Intervention
Breathe Easy Coalition written materials
Study Arms / Comparison Groups
All Participants
Description: Breathe Easy Coalition written materials provided to parent/guardian, plus Maine Tobacco Helpline referral provided to smoking adult in the home, plus testing of the child's urine cotinine and results reported to parent/guardian
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
3
Start Date
March 12, 2017
Completion Date
April 30, 2017
Primary Completion Date
March 30, 2017
Eligibility Criteria
Inclusion Criteria:
- age 0 to 10 years old
- admitted to The Barbara Bush Children Hospital for bronchiolitis, pneumonia,
bronchopulmonary dysplasia, or asthma
- the child lives with an adult who smokes cigarettes
Exclusion Criteria:
- Non-English-speaking and -reading adults will be excluded as our interventions are in
English.
- Children over the age of 10 will be excluded as we wanted to avoid children who
themselves smoke, given that we will not have a confidential way to assess this.
- Breastfeeding children will be excluded as nicotine is transferrable in breast milk.
- Families (meaning the parent or guardian, the child, and any smoking coinhabiting
caregiver) will be excluded if the parent or the smoking adult is a minor, as they
would not be able to give consent for participation.
- Children in foster care or whose guardian is the state will be excluded as we are
unlikely to achieve timely consent.
- Families who do not reside in Maine will be excluded as The Maine Tobacco Helpline is
not able to provide services for out-of-state residents.
- Children readmitted to the hospital during our study period will be excluded if they
have already participated in this study during a previous admission.
Gender
All
Ages
N/A - 10 Years
Accepts Healthy Volunteers
No
Contacts
Deirdre Burns, MD, MPH, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03062709
Organization ID
986404-3
Responsible Party
Principal Investigator
Study Sponsor
MaineHealth
Study Sponsor
Deirdre Burns, MD, MPH, Principal Investigator, MaineHealth
Verification Date
May 2017