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

470 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{2 3 4 6 7}

How is the ISA-MI treatment different from other treatments for preventing Sudden Infant Death Syndrome?

The ISA-MI treatment is unique because it combines an Infant Sleep Assessment with Motivational Interviewing, focusing on personalized guidance and behavior change to promote safe sleep practices, unlike other interventions that may not emphasize individualized motivational techniques. ^{2 3 4 5 8}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Safe Sleep Training for Home Visitors and Their Clients. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Infant Safe Sleep Promotion: Increasing Capacity of Child Protective Services Employees. [2021]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Safe Infant Sleep Interventions: What is the Evidence for Successful Behavior Change? [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Infant Safe Sleep Practices in the United States. [2021]

5. Switzerland 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Observed compliance with safe sleeping guidelines in licensed childcare services. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Infant Safe Sleep Interventions, 1990-2015: A Review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Wahakura Versus Bassinet for Safe Infant Sleep: A Randomized Trial. [2021]