Actively Recruiting

Phase Not Applicable
Age: 3Days - 75Years
All Genders
Healthy Volunteers
ID05503771

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

Age: 3Days - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

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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

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