Intervention Group: ISA-MI for Sudden Infant Death

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sudden Infant Death+3 More
ISA-MI - Behavioral
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions
  • Sudden Infant Death
  • Sudden Unexplained Infant Death

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

9 Primary · 6 Secondary · Reporting Duration: Through Study Completion, an average of 2-3 years

2-month Well Baby Visit
Assess quality of infant safe sleep counseling provided by clinicians trained in Motivational Interviewing skills
Assess quality of infant safe sleep counseling provided by clinicians using new EMR-based tool
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.
Improvements 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.
Improvements 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.
4 months
Change in parents' satisfaction with care provided by clinical residents
Change 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 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.
Review parents' experiences using the ISA tool
Review parents' experiences using the ISA tool as assessed by the Visit Exit Checklist (VEC) survey after the 4-month Well Baby Visit.
Year 3
Analyze ISA's advantages and disadvantages over standard anticipatory guidance
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).
Analyze clinicians' experiences with the ISA intervention
Interventional procedure

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Intervention Group: ISA-MI
1 of 1
Experimental Treatment

683 Total Participants · 1 Treatment Group

Primary Treatment: Intervention Group: ISA-MI · No Placebo Group · N/A

Intervention Group: ISA-MI
Behavioral
Experimental Group · 1 Intervention: ISA-MI · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 2-3 years

Who is running the clinical trial?

Johns Hopkins Bloomberg School of Public HealthLead Sponsor
365 Previous Clinical Trials
2,064,256 Total Patients Enrolled
1 Trials studying Sudden Infant Death
214 Patients Enrolled for Sudden Infant Death
National Institute on Minority Health and Health Disparities (NIMHD)NIH
279 Previous Clinical Trials
701,588 Total Patients Enrolled
Marisabel Cordon Villa de Leon, MPHStudy DirectorDivision of General Pediatrics
Barry Solomon, MD, MPHPrincipal InvestigatorDivision of General Pediatrics
Eileen M McDonald, MSPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health

Eligibility Criteria

Age Any Age · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Maryland recognizes teen parents as emancipated minors, so they will be eligible to provide consent and participate.
You are the parents or legal guardians of infants who are under the age of 18 years.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 28th, 2021

Last Reviewed: October 30th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.