Recruiting

ISA with MI

Sponsor:

Johns Hopkins University

Code:

NCT05503771

Conditions

Sudden Infant Death

Sudden Unexplained Infant Death

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

Interventions

ISA-MI

Standard of Care (SOC)

Study Details

Brief summary:

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.

Conditions

Sudden Infant Death

Sudden Unexplained Infant Death

Study ID

NCT05503771

Start date

Sep 30, 2022

Status verified date

Jul, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Jul 15, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention Group: ISA-MI

The ISA-MI study condition involves, in addition to the standard of care described for the SOC group, a clinician training activity related to using the ISA (Infant Sleep Assessment) tool. Clinicians assigned to the ISA-MI Group will view a 20-30-minute recorded video training session on infant safe sleep (including its epidemiology, risk factors and recommendations), use of the ISA tool, and use of motivational interviewing-inspired (MI) communication skills to respond to ISA parent responses. The ISA tool builds on the 2022 AAP infant sleep recommendations and will be implemented at the 2-month WBV.

Parents/patients of physicians in the ISA-MI study condition will also be given several infant safe sleep related products that facilitate compliance with safe sleep recommendations, namely, a portable crib, a sleep sack and a pacifier.

other: Control Group: Standard of Care (SOC)

The SOC study condition consists of WBVs that follow the usual practice of American Academy of Pediatrics (AAP) Bright Futures Health Supervision Guidelines and includes age- and developmentally based anticipatory guidance. As part of their training, pediatric residents receive formal teaching on core aspects of providing primary care to infants, including the AAP recommendations on safe sleep. This includes the recommended ABCS: babies should sleep Alone (no objects or people), on their Back (supine), in a Crib (or safe alternative including portable crib or bassinet), and in a Smoke-free environment.

Interventions

ISA-MI

Parents seen by clinicians randomized to the intervention group will complete the Infant Sleep Assessment (ISA), either prior to their visit using MyChart (Epic patient portal) or on a tablet computer in the exam room while they wait for their clinician; 2) a Clinical Decision Support (CDS) smart form is created in the EMR based on the assessment results, with risks and MI-informed strategies highlighted; this information will be derived from a pre-programmed algorithm and theory-based, tailored communication strategies and messages; 3) the clinician uses the CDS smart form to guide counseling with the parent during the visit, applying their training in MI-informed counseling skills; and 4) Clinician gives the parent an After Visit Summary (AVS) from the EMR (or informs them that they can access the AVS in MyChart if the parent or other caregivers use the patient portal, MyChart), which summarizes and reinforces the safe sleep counseling.

Standard of Care (SOC)

Parents seen by clinicians randomized to the control group will receive the usual practice that pediatric residents are taught which follows the American Academy of Pediatrics (AAP) Bright Futures Health Supervision Guidelines and includes age and developmentally based anticipatory guidance. As part of their training, residents receive formal teaching on core aspects of providing primary care to infants, including the AAP recommendations on safe sleep. This includes the recommended ABCS: babies should sleep Alone (no objects or people), on their Back (supine), in a Crib (or safe alternative including portable crib or bassinet), and in a Smoke-free environment.

Primary outcome measure

  • Changes in quality of infant safe sleep counseling provided by clinicians using new EMR-based tool as assessed by listening to recorded 2-month Well Baby Visits for control and intervention groups. [ Time Frame: 2-month Well Baby Visit ]
  • Changes in quality of infant safe sleep counseling provided by clinicians trained in Motivational Interviewing skills as assessed by listening to recorded 2-month Well Baby Visits for control and intervention groups. [ Time Frame: 2-month Well Baby Visit ]
  • Changes in parents' satisfaction with care provided by clinical residents as assessed by the follow-up survey parents in both control and intervention groups will receive at the 4-month Well Baby Visit. [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Marisa Cordon Villa de Leon, MPH

443-564-0185mcordon4@jh.edu

Eileen M McDonald, MS

410-428-9063emcdona1@jhu.edu

Locations

Harriet Lane Clinic

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Marisa Cordon Villa de Leon, MPH

443-564-0185mcordon4@jh.edu

Barry Solomon, MD

bsolomon@jhmi.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • Counseling
  • Motivational Interviewing
  • Medical Informatics
  • Clinical Decision Support
  • Electronic Medical Record

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-07-21.