Sleep Assessment Tool & Training for Preventing Sudden Infant Death Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify whether participants need to stop taking their current medications.
Is the Sleep Assessment Tool & Training for Preventing Sudden Infant Death Syndrome safe for humans?
The research articles reviewed focus on interventions to promote safe sleep practices for infants, but they do not provide specific safety data for the Sleep Assessment Tool & Training itself. However, these interventions generally aim to educate caregivers and professionals on safe sleep practices, which are considered safe and beneficial for reducing the risk of sleep-related infant deaths.12345
How is the ISA-MI treatment different from other treatments for preventing Sudden Infant Death Syndrome?
What data supports the effectiveness of the treatment ISA-MI for preventing Sudden Infant Death Syndrome?
Research shows that Motivational Interviewing (a counseling approach) can effectively increase knowledge about safe sleep practices among families, which is a key component of the ISA-MI treatment. However, more research is needed to determine if this knowledge leads to changes in behavior that prevent sleep-related infant deaths.34568
Who Is on the Research Team?
Barry Solomon, MD, MPH
Principal Investigator
Division of General Pediatrics
Eileen M McDonald, MS
Principal Investigator
Johns Hopkins Bloomberg School of Public Health
Marisabel Cordon Villa de Leon, MPH
Principal Investigator
Division of General Pediatrics
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Clinicians receive training on the Infant Sleep Assessment (ISA) tool and Motivational Interviewing (MI) skills, and implement these during 2-month Well Baby Visits.
Follow-up
Participants are monitored for changes in infant sleep practices and clinician-parent communication effectiveness, with follow-up surveys conducted at the 4-month Well Baby Visit.
Study Completion
Clinicians' experiences with the ISA intervention are assessed through a close-out survey upon study completion or clinician graduation.
What Are the Treatments Tested in This Trial?
Interventions
- ISA-MI
- Standard of Care (SOC)
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Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Johns Hopkins Bloomberg School of Public Health
Lead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator