Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2018-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nicotine Patch as an Adjunctive Intervention to Reduce Secondhand Smoke Among NICU Families

NCT04045964

Environmental Tobacco Smoke Smoking Cessation

COMPLETED PHASE4

Clinical Response to Biomarker Documentation of Child Secondhand Smoke Exposure

NCT01145729

Biomarker Feedback Smoking Cessation Secondhand Smoke Exposure +1 more

UNKNOWN NA

Motivating Smokers--Reduce Child Environmental Tobacco Smoke Exposure

NCT00005396

Lung Diseases

COMPLETED

Anti-Smoking Program for Parents: Effects on Child Smoking

NCT00056927

Smoking

COMPLETED NA

Tailored Videos to Reduce Tobacco Smoke Exposure Among Pregnant Women and Newborns

NCT00142623

Cardiovascular Diseases Heart Diseases

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Exposure to Secondhand Smoke in Neonatal Infants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Motivational Interviewing plus Incentives

Group Type EXPERIMENTAL

Motivational Interviewing plus Incentives

Intervention Type BEHAVIORAL

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)

Group Type OTHER

Conventional Care (CC)

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Conventional Care (CC)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes