Home › Sudden Infant Death Syndrome › NCT05503771
Improving Pediatrician Counseling About Infant Safe Sleep Using the Electronic Medical Record
Health IT to Reduce Disparities in Risks for Sleep-related Infant Deaths, (SAFE Start 2.0 Project)
Who can join
3 Days – 75 Years · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * English and Spanish-speaking parents and legal guardians bringing their infants to the Harriet Lane Clinic (pediatric primary care clinic) for any of their early well baby visits (between 3-5 days up to 4 weeks of age) * Maryland recognizes teen parents as emancipated minors, so they will be eligible to provide consent and participate. Exclusion Criteria: * Infant is considered medically complex (e.g., serious congenital anomaly, requires cardiorespiratory monitoring, etc.) * Assigned resident is not enrolled in the study
About the study
The study team will evaluate the impact of an Infant Sleep Assessment (ISA) tool with motivational interviewing (MI) communication training on clinician-parent communication during 2-month Well Baby Visits (WBV) and parent reported and observed infant sleep practices. The study team's hypotheses are that 1) clinicians who utilize the ISA with MI training will more effectively communicate safe sleep information to their patients' parents, and 2) these parents will have safer infant sleep practices than parents whose clinicians are in a standard of care control group.
What is being tested
- ISA-MI (behavioral)
- Standard of Care (SOC) (other)
Sponsor: Johns Hopkins University · Participants: 350 · Started: Sep 30, 2022
Contact the study team
- Marisa Cordon Villa de Leon, MPH · Phone: 443-564-0185
- Eileen M McDonald, MS · Phone: 410-428-9063
Official record on ClinicalTrials.gov — NCT05503771
Locations in the U.S.
| Maryland | Harriet Lane Clinic, Baltimore |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.