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Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes

This study is currently recruiting participants.
Verified June 2013 by The University of Texas Health Science Center, Houston
Sponsor:
Collaborators:
Memorial Hermann Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Angela Stotts, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01726062
First received: November 6, 2012
Last updated: June 13, 2013
Last verified: June 2013
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes (The Baby's Breath II Project)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Infant Second-Hand Smoke Exposure via Saliva Cotinine [ Time Frame: Follow-up visit 4 months post-treatment ] [ Designated as safety issue: No ]
    Infant Second-Hand Smoke Exposure (SHSe) measures will be determined via saliva cotinine.


Secondary Outcome Measures:
  • Secondhand Smoke Exposure outcomes [ Time Frame: Change from Baseline to the 4 months post-treatment followup ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 396
Study Start Date: August 2012
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726062

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

Locations
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)
Investigators
Principal Investigator: Angela Stotts, PhD University of Texas at Houston Family and Community Medicine
  More Information

No publications provided

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
Study First Received: November 6, 2012
Last Updated: June 13, 2013
Health Authority: United States: National Heart, Lung, and Blood Institute (NHLBI)

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

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on June 13, 2013