Sleep Assessment Tool & Training for Preventing Sudden Infant Death Syndrome

Overseen By Marisa Cordon Villa de Leon, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Medically complex infants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help doctors communicate with parents about safe sleep practices for infants. It uses a tool called the Infant Sleep Assessment with Motivational Interviewing (ISA-MI) and trains doctors to use motivational interviewing techniques. The researchers aim to determine if this approach improves parents' adherence to safe sleep guidelines compared to standard advice. English or Spanish-speaking parents bringing their newborns to the Harriet Lane Clinic for early well-baby checkups may find this trial suitable. However, parents with medically complex infants, such as those with serious conditions, are not eligible. As an unphased trial, this study offers parents the chance to contribute to innovative research that could enhance infant care practices.

Will I have to stop taking my current medications?

The trial does not specify whether participants need to stop taking their current medications.

What prior data suggests that the ISA-MI tool and training are safe for improving infant sleep practices?

Research has shown that using tools like the Infant Sleep Assessment (ISA) with Motivational Interviewing (MI) training is generally well-received. One study found that these methods helped families better understand and follow safe sleep advice, increasing the number of infants sleeping in safe environments.

No significant safety concerns have been reported with the ISA-MI tool itself. The main goal is to help parents and healthcare providers communicate and practice safe sleep for infants more effectively. This approach is educational rather than a medical treatment, which usually means it carries fewer risks.

Since this trial is labeled as "Not Applicable" for its phase, it focuses on gathering information rather than testing a new drug or medical device, suggesting that safety risks are likely low. Overall, the ISA-MI approach appears safe based on current data. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces a new approach called the ISA-MI, which combines the Infant Sleep Assessment tool with motivational interviewing-inspired communication. Unlike the standard of care that focuses on general safe sleep guidelines, ISA-MI aims to personalize the advice for parents using specific assessments and enhanced communication skills. This method not only educates clinicians on the latest safe sleep recommendations but also equips parents with practical tools like portable cribs, sleep sacks, and pacifiers to facilitate safer infant sleep environments. By tailoring guidance and providing supportive products, ISA-MI has the potential to more effectively reduce the risk factors associated with Sudden Infant Death Syndrome (SIDS).

What evidence suggests that the ISA-MI tool is effective for preventing Sudden Infant Death Syndrome?

Research has shown that tools like the Infant Sleep Assessment (ISA) combined with Motivational Interviewing (MI) can help parents adhere to safe sleep practices for their babies. Participants in the ISA-MI group of this trial will receive these interventions. Studies have found that MI enhances parents' understanding of safe sleep, which is crucial for preventing Sudden Infant Death Syndrome (SIDS). Programs teaching caregivers these communication methods have successfully created safer sleep environments for infants. The ISA tool is based on recommendations from the American Academy of Pediatrics, which have been proven to lower the risk of SIDS. Overall, these methods show promise in improving infant sleep habits. ^{2 6 7 8 9}

Who Is on the Research Team?

Eileen M McDonald, MS

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Barry Solomon, MD, MPH

Principal Investigator

Division of General Pediatrics

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

I am a parent or guardian of an infant visiting Harriet Lane Clinic for early well baby visits.

Maryland recognizes teen parents as emancipated minors, so they will be eligible to provide consent and participate.

Exclusion Criteria

Assigned resident is not enrolled in the study

Infant is considered medically complex (e.g., serious congenital anomaly, requires cardiorespiratory monitoring, etc.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

2 months

1 visit (in-person)

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.

4 months

1 visit (in-person)

Study Completion

Clinicians' experiences with the ISA intervention are assessed through a close-out survey upon study completion or clinician graduation.

2-3 years

What Are the Treatments Tested in This Trial?

Interventions

• ISA-MI
• Standard of Care (SOC)

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Group: ISA-MI Experimental Treatment 1 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 Treatment 1 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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

Implementing safe sleep practices can significantly lower the risk of sleep-related deaths in infants, highlighting the importance of proper sleeping environments.

Educating caregivers about safe sleep guidelines is crucial for enhancing infant safety during sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infant Safe Sleep Practices in the United States. Bombard, JM., Kortsmit, K., Cottengim, C., et al.[2021]

The study involving 200 mainly Māori pregnant women found that using the wahakura sleep device did not increase risky infant behaviors such as bed-sharing or unsafe sleep positions compared to traditional bassinets.

Infants using the wahakura had a significantly higher rate of full breastfeeding at 6 months (22.5% vs 10.7%), suggesting that wahakura may support better breastfeeding practices while maintaining safety for infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wahakura Versus Bassinet for Safe Infant Sleep: A Randomized Trial. Baddock, SA., Tipene-Leach, D., Williams, SM., et al.[2021]

Sudden Unexpected Infant Death (SUID), particularly from Sudden Infant Death Syndrome (SIDS), is a major cause of infant mortality, and while many interventions focus on safe sleep practices, tobacco exposure has not been adequately addressed despite being a key risk factor.

This review highlights the need for comprehensive strategies that include tobacco reduction and cessation in safe sleep interventions, synthesizing findings from 10 studies to recommend future research and practices aimed at reducing sleep-related infant deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

When there is no air, the cradle will fall: A narrative review of tobacco-related content across infant safe sleep interventions. Jawed, A., Jassal, M.[2022]

The Kansas Infant Death and SIDS (KIDS) Network Safe Sleep Instructor training significantly improved the knowledge of safe sleep recommendations among Child Protective Services (CPS) staff, who initially had lower baseline knowledge compared to other participants.

CPS staff, after receiving the training, went on to provide more safe sleep education to professionals than their counterparts, demonstrating the program's effectiveness in enhancing community training efforts to prevent sleep-related infant deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infant Safe Sleep Promotion: Increasing Capacity of Child Protective Services Employees. Ahlers-Schmidt, CR., Schunn, C., Hervey, AM., et al.[2021]

Sudden infant death syndrome (SIDS) and other sleep-related deaths account for over 4,000 infant deaths annually in the USA, highlighting the urgent need for effective interventions.

The review discusses various safe sleep interventions that have been implemented to change infant sleep practices, noting that while some caregivers resist these evidence-based recommendations, there is evidence supporting their effectiveness in reducing sleep-related deaths.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe Infant Sleep Interventions: What is the Evidence for Successful Behavior Change? Moon, RY., Hauck, FR., Colson, ER.[2019]

Training home visitors in Motivational Interviewing and cultural sensitivity significantly improved their skills and knowledge about infant safe sleep practices, as shown in a study with 23 home visitors.

The intervention led to greater increases in safe sleep knowledge among home visiting clients (78 participants) compared to a control group, although it did not significantly change their attitudes or behaviors regarding safe sleep practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Safe Sleep Training for Home Visitors and Their Clients. Chahin, S., Damashek, A., Ospina, F., et al.[2022]

A study of 18 licensed childcare settings in Australia found that 83% were non-compliant with at least one safe sleeping guideline for infants, highlighting significant safety concerns despite existing regulations.

Common issues included 44% of settings placing infants in prone or side positions and 67% using unsafe bedding like quilts and pillows, indicating a need for improved adherence to safe sleeping practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Observed compliance with safe sleeping guidelines in licensed childcare services. Staton, S., Pattinson, C., Smith, S., et al.[2020]

A systematic review of 29 studies on interventions to reduce sleep-related infant deaths found that multi-faceted approaches, including education and resource provision, were generally effective in changing some infant sleep practices, though complete adherence to safe sleep recommendations was not achieved.

Interventions targeted various behaviors such as sleep position and crib safety, and included methods like one-on-one education, printed materials, and health professional training, highlighting the importance of comprehensive strategies in promoting safe sleep for infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infant Safe Sleep Interventions, 1990-2015: A Review. Salm Ward, TC., Balfour, GM.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4997961/

Safe Infant Sleep Interventions: What is the Evidence for ... In this review, we will discuss illustrative examples of safe infant sleep interventions and evidence of their effectiveness.

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK513383/

Preventive Strategies for Sudden Infant Death Syndrome - NCBI In this chapter we will outline the principles of public health approaches to prevention and the evidence base for different strategies.

3. mchlibrary.org mchlibrary.org/evidence/established-results.php?Measure_Code=safe-sleep&MCHbest_Code=safe-sleep-01&Strategy=Caregiver/Parent%20Education

Established Evidence Results Conclusion: MI may be an effective technique for home visitors to help increase families' safe sleep knowledge. Additional research is needed to examine whether ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03494621

Study Details | NCT03494621 | Infant Care Practices Study The curriculum combines culturally-based prenatal and infant care education with current safe sleep recommendations from the American Academy of Pediatrics (AAP) ...

5. researchgate.net researchgate.net/publication/258056400_Safe_Sleep_Practices_and_Sudden_Infant_Death_Syndrome_Risk_Reduction_NICU_and_Well-Baby_Nursery_Graduates

Safe Sleep Practices and Sudden Infant Death Syndrome ... This study evaluated the efficacy of a program to train home visitors to talk to clients about infant safe sleep using Motivational Interviewing and cultural ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10921318/

A Risk Assessment and Planning Tool to Prevent Sudden ... This study aimed to develop and evaluate a risk assessment and planning tool designed to improve the uptake of safer sleep advice in families with infants at ...

7. michigan.gov michigan.gov/-/media/Project/Websites/mdhhs/Folder3/Folder28/Folder2/Folder128/Folder1/Folder228/2016_ISS_Focus_Groups_Professionals.pdf?rev=b656feecf49d48b596e6fdb95bd309d3

2016 Infant Safe Sleep Focus Groups with Professionals Sleep‐related infant death is a leading cause of death among infants less than 1 year in Michigan. Sleep‐ related infant deaths include any death wherein the ...

8. publications.aap.org publications.aap.org/pediatrics/article/144/5/e20191286/76992/Prevalence-and-Factors-Associated-With-Safe-Infant

Prevalence and Factors Associated With Safe Infant Sleep ... To examine prevalence of safe infant sleep practices and variation by sociodemographic, behavioral, and health care characteristics, including provider advice.

9. mchlibrary.org mchlibrary.org/evidence/established-results.php?Measure_Code=safe-sleep&MCHbest_Code=safe-sleep-03

Established Evidence Results There was a significant increase in the percent of infants sleeping in a safe sleep environment following the intervention (5.9 to 39.8%, p < 0.01). Overall ABC ...