A Study of Tobacco Smoke and Children With Respiratory Illnesses

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 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

NCT ID

NCT03062709

Organization ID

986404-3

Responsible Party

Principal Investigator

Study Sponsor

Maine Medical Center

Study Sponsor

Deirdre Burns, MD, MPH, Principal Investigator, Maine Medical Center

Verification Date

May 2017