Improving Pediatrician Counseling About Infant Safe Sleep Using the Electronic Medical Record
Johns Hopkins University · with National Institute on Minority Health and Health Disparities (NIMHD) · NCT05503771
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 0 mo–75 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 350
- US sites recruiting
- 1
- Study start
- September 30, 2022
- Record last updated
- July 21, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: ISA-MI; Standard of Care (SOC)
Conditions: Sudden Infant Death; Sudden Unexplained Infant Death
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
Harriet Lane Clinic
Baltimore, MD 21287
Site contact: Marisa Cordon Villa de Leon, MPH · 443-564-0185 · mcordon4@jh.edu
Study contacts (from the official record)
- Marisa Cordon Villa de Leon, MPH · 443-564-0185 · mcordon4@jh.edu
- Eileen M McDonald, MS · 410-428-9063 · emcdona1@jhu.edu
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