Exposure to Secondhand Smoke in Neonatal InfantsPhase 2NCT01726062
Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes
A Phase 2 study testing Motivational Interviewing plus Incentives and Conventional Care (CC) in people with Exposure to Secondhand Smoke in Neonatal Infants, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Exposure to Secondhand Smoke in Neonatal Infants
- What is being tested?
- Motivational Interviewing plus Incentives and Conventional Care (CC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to 30 Jan 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Memorial Hermann Hospital
Houston, Texas, 77030
About this study
Official title: Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes (The Baby's Breath II Project)
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.
- Being tested
- Motivational Interviewing plus Incentives, Conventional Care (CC)
- 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
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing plus IncentivesBehavioural
- Two hospital-based, face-to-face MI+ sessions
- Two home-based MI+ sessions
- Attendance at each session and for the establishment of a household smoking ban at two timepoints post-discharge
Conventional Care (CC)Behavioural
Participants in this arm will receive brochures and a brief information meeting in the NICU.
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing plus Incentives | Experimental | Not described Receives: Behavioral: Motivational Interviewing plus Incentives |
| Conventional Care (CC) | Other | Not described Receives: Behavioral: Conventional Care (CC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Second-Hand Smoke Exposure via Urine Cotinine
Infant Second-Hand Smoke Exposure (SHSe) measures will be determined via urine cotinine.
Measured: 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.
Measured: Change from Baseline to the 4 months post-treatment followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startAug 2012
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exposure to Secondhand Smoke in Neonatal InfantsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Hermann Hospital, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Angela Stotts, The University of Texas Health Science Center, Houston
- Investigators
- Angela Stotts, PhD, Principal investigator, University of Texas at Houston Family and Community Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726062
- Sponsor's protocol ID
- HSC-MS-11-0641
- Other IDs
- 1R01HL107404-01A1
- Status last verified
- May 2018
- First submitted
- 6 Nov 2012
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes (The Baby's Breath II Project)
- ClinicalTrials.gov ID
- NCT01726062
- Acronym / sponsor ID
- HSC-MS-11-0641
- Keywords
- Motivational Incentives, Motivational Interviewing, Secondhand Smoke, Neonatal Intensive Care Unit, NICU, High respiratory risk infants, Low birth weight infants, Environmental Tobacco Smoke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Memorial Hermann Hospital, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2012 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 14 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing plus Incentives | Experimental | Behavioral: Motivational Interviewing plus Incentives |
| Conventional Care (CC) | Other | Behavioral: Conventional Care (CC) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing plus Incentives1. 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 | Behavioural | Motivational Interviewing plus Incentives |
| Conventional Care (CC)Participants in this arm will receive brochures and a brief information meeting in the NICU. | Behavioural | Conventional Care (CC) |
Primary outcome
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.
1 secondary outcome
Secondhand Smoke Exposure outcomes
Time frame: Change from Baseline to the 4 months post-treatment followup
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2018.
- Derived from this study: PubMed 31870605Stotts 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Stotts, PhD principal investigator
University of Texas at Houston Family and Community Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Motivational Interviewing plus Incentives and Conventional Care (CC) in people with Exposure to Secondhand Smoke in Neonatal Infants, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Second-Hand Smoke Exposure via Urine Cotinine (time frame: Follow-up visit 4 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01726062, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2018.