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Completed

NCT Number: NCT01726062

Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes

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.

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Key information

Conditions

Exposure to Secondhand Smoke in Neonatal Infants Behavior Smoking

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motivational Interviewing plus Incentives

Behavioral
  • 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

Conventional Care (CC)

Behavioral

Participants in this arm will receive brochures and a brief information meeting in the NICU.

Primary outcomes

  1. 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

  1. Secondhand Smoke Exposure outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Memorial Hermann Hospital
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Nov 14, 2012
Registry last updated
May 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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