Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04832659
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2021-03-25
Brief Title:
Assessment of Biomarkers in Children to Help Parents Quit Tobacco
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Assessment of Biomarkers in Children to Help Parents Quit Tobacco
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABC Quit
Brief Summary:
This randomized controlled trial will test whether adding biomarker measurement and informed outreach for tobacco smoke exposure as part of routine practice increases identification and improves treatment effectiveness and sustainability of a parental tobacco control intervention that will be integrated into pediatric practice
Detailed Description:
This trial will examine the effectiveness of systematic cotinine testing of children 12 years old or younger using blood already collected at any visit to a practice that sees pediatric patients where there is a clinically indicated blood draw We hypothesize that providing cotinine biomarker results to pediatricians personalized cotinine feedback to parents about their childs toxin exposure and offering support to all household tobacco users to quit tobacco use Biomarker Informed Outreach BIO when added to the Clinical Effort Against Secondhand Smoke Exposure CEASE intervention will increase delivery of tobacco cessation assistance increase household cessation reduce tobacco smoke exposure in children and be cost-effective This is a 2-arm randomized controlled trial with family-level randomization to either CEASEBIO or CEASE arms at the time of the childs baseline visit To compare the effectiveness of CEASEBIO vs CEASE we will follow-up with enrolled parents 12 months later to assess parental quit rate and childrens tobacco smoke exposure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01CA248742 | NIH | None | httpsreporternihgovquickSearchR01CA248742 |