NCT01726062

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
Last Updated

May 14, 2018

Status Verified

May 1, 2018

Enrollment Period

5.5 years

First QC Date

November 6, 2012

Last Update Submit

May 8, 2018

Conditions

Exposure to Secondhand Smoke in Neonatal Infants

Keywords

Motivational IncentivesMotivational InterviewingSecondhand SmokeNeonatal Intensive Care UnitNICUHigh respiratory risk infantsLow birth weight infantsEnvironmental Tobacco SmokeSmokingContingency managementInfantsChildren

Outcome Measures

Primary Outcomes (1)

  • Infant Second-Hand Smoke Exposure via Urine Cotinine

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

    Follow-up visit 4 months post-treatment

Secondary Outcomes (1)

  • Secondhand Smoke Exposure outcomes

    Change from Baseline to the 4 months post-treatment followup

Study Arms (2)

Motivational Interviewing plus Incentives

EXPERIMENTAL
Behavioral: Motivational Interviewing plus Incentives

Conventional Care (CC)

OTHER
Behavioral: Conventional Care (CC)

Interventions

Motivational Interviewing plus IncentivesBEHAVIORAL

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

Motivational Interviewing plus Incentives
Conventional Care (CC)BEHAVIORAL

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

Conventional Care (CC)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 31870605DERIVED

MeSH Terms

Conditions

Smoking

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Angela Stotts, PhD

    University of Texas at Houston Family and Community Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor - Family Medicine

Study Record Dates

First Submitted

November 6, 2012

First Posted

November 14, 2012

Study Start

August 1, 2012

Primary Completion

January 30, 2018

Study Completion

January 30, 2018

Last Updated

May 14, 2018

Record last verified: 2018-05

Locations

US(1)