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Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01726062
Recruitment Status : Recruiting
First Posted : November 14, 2012
Last Update Posted : October 26, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Exposure to Secondhand Smoke in Neonatal Infants Behavioral: Motivational Interviewing plus Incentives Behavioral: Conventional Care (CC) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes (The Baby's Breath II Project)
Study Start Date : August 2012
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01726062

Contact: Angela L Stotts, PhD 7135007590 Angela.L.Stotts@uth.tmc.edu
Contact: Thomas F Northrup, PhD 7135007590 Thomas.F.Northrup@uth.tmc.edu

United States, Texas
Children's Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Angela L Stotts, PhD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Memorial Hermann Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Angela Stotts, PhD University of Texas at Houston Family and Community Medicine
More Information

Responsible Party: Angela Stotts, Associate Professor - Family Medicine, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01726062     History of Changes
Other Study ID Numbers: HSC-MS-11-0641
1R01HL107404-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 14, 2012    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Angela Stotts, The University of Texas Health Science Center, Houston:
Secondhand Smoke
Environmental Tobacco Smoke
Motivational Incentives
Motivational Interviewing
Neonatal Intensive Care Unit
High respiratory risk infants
Low birth weight infants
Contingency management