A Study of Tobacco Smoke and Children With Respiratory Illnesses

NCT ID: NCT03062709

Last Updated: 2017-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-12
• Study Completion Date: 2017-04-30

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.

Conditions

Bronchiolitis; Pneumonia; Reactive Airway Disease; Asthma; Tobacco Smoking; Tobacco Cessation; Bronchopulmonary Dysplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

All Participants

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

Group Type: EXPERIMENTAL

Breathe Easy Coalition written materials

Intervention Type: BEHAVIORAL

written materials about secondhand and thirdhand environmental smoke exposure in children

Maine Tobacco Helpline

Intervention Type: BEHAVIORAL

referral to tobacco cessation counselor, helpline calls adult referred to provide counseling over the phone.

Urine cotinine testing

Intervention Type: DIAGNOSTIC_TEST

the child's urine is tested for cotinine, which is produced when the body absorbs nicotine. These results are communicated to the child's parent/guardian.

Interventions

Breathe Easy Coalition written materials

written materials about secondhand and thirdhand environmental smoke exposure in children

Intervention Type: BEHAVIORAL

Maine Tobacco Helpline

referral to tobacco cessation counselor, helpline calls adult referred to provide counseling over the phone.

Intervention Type: BEHAVIORAL

Urine cotinine testing

the child's urine is tested for cotinine, which is produced when the body absorbs nicotine. These results are communicated to the child's parent/guardian.

Intervention Type: DIAGNOSTIC_TEST

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.

• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MaineHealth

OTHER

Sponsor Role: lead

Responsible Party

Deirdre Burns

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deirdre Burns, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

MaineHealth

Locations

The Barbara Bush Children's Hospital at Maine Medical Center

Portland, Maine, United States

Countries

United States

Related Links

http://breatheeasymaine.org/

Breathe Easy Coalition

Other Identifiers

986404-3

Identifier Type: -

Identifier Source: org_study_id