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Behavioral Intervention

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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.

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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Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,257 Previous Clinical Trials

14,819,661 Total Patients Enrolled

National Institute on Minority Health and Health Disparities (NIMHD)NIH

380 Previous Clinical Trials

1,215,184 Total Patients Enrolled

Johns Hopkins Bloomberg School of Public HealthLead Sponsor

410 Previous Clinical Trials

2,116,460 Total Patients Enrolled

Media Library

ISA-MI (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05503771 — N/A

Sudden Infant Death Syndrome Research Study Groups: Intervention Group: ISA-MI, Control Group: Standard of Care (SOC)

Sudden Infant Death Syndrome Clinical Trial 2023: ISA-MI Highlights & Side Effects. Trial Name: NCT05503771 — N/A

ISA-MI (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05503771 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the minimum age requirement for this research 18?

"Patients aged 3 days to 75 years old are allowed to join this clinical trial. Moreover, 27 trials involve minors and 74 involve seniors."

Answered by AI

How many participants are actively involved in this trial?

"That is correct. Clinicaltrials.gov reveals that this clinical trial, initially posted on October 19th 2022, is continuing to recruit patients. 683 participants are needed from 1 medical centre for the completion of this study."

Answered by AI

What is the ultimate aim of this research endeavor?

"In a two-month period, this clinical trial will measure the alteration in parents' satisfaction with care provided by medical residents. Additionally, participants will assess the ISA tool's plus points and drawbacks compared to traditional anticipatory guidance through MyChart. The close-out survey which concludes either upon completion of study or when clinicians graduate aims to evaluate reactions to using the ISA (preparation, contentment, facilitation of use, self-efficacy, burnout, impact on balancing measures)."

Answered by AI

Are there any open slots in this experiment?

"Clinicaltrials.gov confirms that this medical research is actively looking for participants, with the original posting of October 19th 2022 and most recent update on October 25th 2022."

Answered by AI

Would it be possible to partake in this clinical experiment?

"This investigation is in search of 683 infants between 3 days and 75 years old who have suffered from sudden death. Key requirements for potential participants include: Maryland consenting minors must be emancipated, and parents or guardians need to bring their baby to the Harriet Lane Clinic (a paediatric primary care clinic) during an early well-baby visit (between three days up until 4 weeks)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Improving Pediatrician Counseling About Infant Safe Sleep Using the Electronic Medical Record

2022. "Improving Pediatrician Counseling About Infant Safe Sleep Using the Electronic Medical Record". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05503771.