Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes

Study Overview
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Brief Summary
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A randomized, controlled, parallel group design will be used to test whether a Secondhand Smoke Exposure program initiated in the hospital and completed in the home using motivational interviewing plus motivational incentives (MI+) is more effective than Conventional Care (CC) with Neonatal Incentives Care Unit Infants' parents.

Official Title
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Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes (The Baby's Breath II Project)

Conditions
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Exposure to Secondhand Smoke in Neonatal Infants

Intervention / Treatment
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* Behavioral: Motivational Interviewing plus Incentives
* Behavioral: Conventional Care (CC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have an infant that is at least 1 week prior to the estimated date of hospital discharge in the NICU at Children's Memorial Hermann Hospital (CMHH) Report at least one person living in the home who smokes Agree to attend intervention sessions and to invite other household members Live within 50 miles of our center Have access to a telephone. Exclusion Criteria: Severe cognitive, and/or psychiatric impairment, per judgment of NICU and research staff, that precludes cooperation with study protocol Inability to read, write, and speak English or Spanish Inability or unwillingness to provide signed consent for participation Inability or unwillingness to meet study requirements, including home visits for data collection and intervention purposes.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Interviewing plus Incentives<br> | Behavioral: Motivational Interviewing plus Incentives<br>* Two hospital-based, face-to-face MI+ sessions Two home-based MI+ sessions Attendance at each session and for the establishment of a household smoking ban at two timepoints post-discharge<br>|
| Other: Conventional Care (CC)<br> | Behavioral: Conventional Care (CC)<br>* Participants in this arm will receive brochures and a brief information meeting in the NICU.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant Second-Hand Smoke Exposure via Urine Cotinine | Infant Second-Hand Smoke Exposure (SHSe) measures will be determined via urine cotinine. | Follow-up visit 4 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondhand Smoke Exposure outcomes | Primary caregiver reports via the Timeline Follow-Back and household air nicotine monitors. Number of cigarettes smoked outdoors vs. indoor and the implementation of household smoking bans will also be assessed. Primary caregivers will complete the SHSe related interviews and self-report questionnaires. Primary caregivers who are smokers will complete measures related to smoking and smoking cessation. | Change from Baseline to the 4 months post-treatment followup | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Motivational Incentives, Motivational Interviewing, Secondhand Smoke, Neonatal Intensive Care Unit, NICU, High respiratory risk infants, Low birth weight infants, Environmental Tobacco Smoke, Contingency management, Infants, Children