NCT01726062
Completed
Phase 2
Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes (The Baby's Breath II Project)
The University of Texas Health Science Center, Houston1 site in 1 country360 target enrollmentAugust 2012
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Exposure to Secondhand Smoke in Neonatal Infants
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 360
- Locations
- 1
- Primary Endpoint
- Infant Second-Hand Smoke Exposure via Urine Cotinine
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Angela Stotts
Associate Professor - Family Medicine
The University of Texas Health Science Center, Houston
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Infant Second-Hand Smoke Exposure via Urine Cotinine
Time Frame: Follow-up visit 4 months post-treatment
Infant Second-Hand Smoke Exposure (SHSe) measures will be determined via urine cotinine.
Secondary Outcomes
- Secondhand Smoke Exposure outcomes(Change from Baseline to the 4 months post-treatment followup)
Study Sites (1)
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