Actively Recruiting
Health IT to Reduce Disparities in Risks for Sleep-related Infant Deaths SAFE Start 2.0 Project
Led by Johns Hopkins University · Updated on 2025-12-09
350
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on reducing unsafe infant sleep practices that increase the risk of Sudden Unexplained Infant Death (SUID), including Sudden Infant Death Syndrome and Accidental Suffocation. The study evaluates how a special Infant Sleep Assessment (ISA) tool combined with Motivational Interviewing (MI) communication training affects conversations between clinicians and parents during 2-month Well Baby Visits. The goal is to see if using this tool helps clinicians better communicate safe sleep practices and if parents then follow safer sleep routines compared to standard care. Parents in the intervention group will have their infant sleep practices assessed using the ISA tool either before or during the visit, which generates tailored feedback for clinicians via the electronic medical record. Clinicians trained in MI will use this information to guide counseling. The intervention also includes giving parents safe sleep products like a portable crib, sleep sack, and pacifier. The control group receives standard care based on American Academy of Pediatrics guidelines without the ISA tool or additional training. Participants will attend Well Baby Visits at 2 and 4 months where recorded visits and surveys will assess the quality of clinician counseling and parent satisfaction. Clinicians' experiences with the ISA tool will be collected through surveys at the end of their participation. The study monitors infant sleep practices and clinician-parent communication, with follow-up lasting an average of 2 to 3 years. The study involves English and Spanish-speaking parents and legal guardians of infants aged from a few days up to 4 weeks old at enrollment.
CONDITIONS
Brief Title
Improving Pediatrician Counseling About Infant Safe Sleep Using the Electronic Medical Record
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English and Spanish-speaking parents or legal guardians bringing infants to early Well Baby Visits between 3 days and 4 weeks old
- Maryland recognizes teen parents as emancipated minors who can consent
You will not qualify if you...
- Infant is medically complex (e.g., serious congenital anomaly or requires cardiorespiratory monitoring)
- Assigned pediatric resident is not enrolled in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At 2 months after enrollment
Participants attend the 2-month Well Baby Visit where clinicians use the Infant Sleep Assessment tool and motivational interviewing training to provide safe sleep counseling. Parents in the intervention group also receive safe sleep products including a portable crib, sleep sack, and pacifier to support safe sleep practices.
1 visit (in-person)
Duration - At 4 months after enrollment
Participants complete a follow-up survey and assessment of infant sleep practices at the 4-month Well Baby Visit to evaluate satisfaction with care and adherence to safe sleep recommendations.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Harriet Lane Clinic
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
M
Marisa Cordon Villa de Leon, MPH
E
Eileen M McDonald, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here