Sleep Assessment Tool & Training for Preventing Sudden Infant Death Syndrome

N/A

Recruiting

Led By Eileen M McDonald, MS

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2-3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess how a sleep assessment tool & communication training affect how doctors & parents talk about infant sleep & if it leads to safer sleep practices.

Who is the study for?

This trial is for parents or legal guardians taking their infants to the Harriet Lane Clinic for early well baby visits. It includes teen parents recognized as emancipated minors in Maryland. Infants with serious health issues or non-English speaking parents are excluded.

What is being tested?

The study tests an Infant Sleep Assessment tool combined with motivational interviewing training for pediatricians against standard care, aiming to improve how doctors talk about safe sleep and influence safer sleep practices among parents.

What are the potential side effects?

Since this trial involves communication strategies rather than medical treatments, there are no direct side effects like those associated with medications. The focus is on improving counseling and infant care practices.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2-3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2-3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2-3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

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.

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.

Secondary study objectives

Analyze ISA's advantages and disadvantages over standard anticipatory guidance as assessed by the clinician close-out survey when clinicians graduate or the study ends (whichever happens first).

Interventional procedure

Review parents' experiences using the ISA tool as assessed by the Visit Exit Checklist (VEC) survey after the 4-month Well Baby Visit.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Intervention Group: ISA-MIExperimental Treatment1 Intervention

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.

Group II: Control Group: Standard of Care (SOC)Experimental Treatment1 Intervention

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.

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