Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes

Phase 2

Completed

• Conditions: Exposure to Secondhand Smoke in Neonatal Infants
• Interventions: Behavioral: Conventional Care (CC); Behavioral: Motivational Interviewing plus Incentives

• Registration Number: NCT01726062
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-11-06
• Study First Submitted QC: 2012-11-08
• Study First Posted: 2012-11-14
• Primary Completion: 2018-01-30
• Study Completion: 2018-01-30
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-08
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Care (CC)	Conventional Care (CC)	-
Motivational Interviewing plus Incentives	Motivational Interviewing plus Incentives	-

Primary Outcome Measures

Name	Time	Method
Infant Second-Hand Smoke Exposure via Urine Cotinine	Follow-up visit 4 months post-treatment	Infant Second-Hand Smoke Exposure (SHSe) measures will be determined via urine cotinine.

Secondary Outcome Measures

Name	Time	Method
Secondhand Smoke Exposure outcomes	Change from Baseline to the 4 months post-treatment followup	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.

Trial Locations

Locations (1)

Children's Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States