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CompletedNCT01726062Updated May 14, 2018

Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes

A Phase 2 interventional study of Motivational Interviewing plus Incentives and Conventional Care (CC) in Exposure to Secondhand Smoke in Neonatal Infants, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2018-05-14.

Sponsored by The University of Texas Health Science Center, Houston · Phase 2, Interventional, and Other

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Aug 2012, registered Nov 2012).
Phase
Phase 2
Study type
Interventional
Enrollment
360
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Exposure to Secondhand Smoke in Neonatal Infants

Keywords

  • 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
03

In context

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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.
05

Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
360 participants (actual)

Study arms

  • Experimental
    Motivational Interviewing plus Incentives

    Behavioral: Motivational Interviewing plus Incentives

  • Other
    Conventional Care (CC)

    Behavioral: Conventional Care (CC)

Interventions

  • BehavioralMotivational 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

  • BehavioralConventional Care (CC)

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

06

What researchers measure

Primary outcomes

  1. Infant Second-Hand Smoke Exposure via Urine Cotinine

    Infant Second-Hand Smoke Exposure (SHSe) measures will be determined via urine cotinine.

    Time frame: Follow-up visit 4 months post-treatment

Secondary outcomes

  1. Secondhand Smoke Exposure outcomes

    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.

    Time frame: Change from Baseline to the 4 months post-treatment followup

07

Study locations

1 site
  • Children's Memorial Hermann Hospital
    Houston, Texas 77030, United States
08

References and documents

Publications

  • Stotts AL, Northrup TF, Green C, Suchting R, Hovell MF, Khan A, Villarreal YR, Schmitz JM, Velasquez MM, Hammond SK, Hoh E, Tyson J. Reducing Tobacco Smoke Exposure in High-Risk Infants: A Randomized, Controlled Trial. J Pediatr. 2020 Mar;218:35-41.e1. doi: 10.1016/j.jpeds.2019.10.070. Epub 2019 Dec 20. PubMed 31870605 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01726062
Lead sponsor
The University of Texas Health Science Center, Houston
Collaborators
Memorial Hermann Hospital, National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Angela Stotts (Associate Professor - Family Medicine, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Nov 14, 2012
Start date
Aug 2012
Primary completion
Jan 30, 2018
Completion
Jan 30, 2018
Last update
May 14, 2018

Study contacts

Angela Stotts, PhD
principal investigator · University of Texas at Houston Family and Community Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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