Enhancing Safe Sleep Practices of Urban Low-Income Mothers
2 other identifiers
interventional
214
1 country
1
Brief Summary
The specific aims of the study are to: 1) evaluate the impact of the safe sleep intervention on parents' knowledge, beliefs, intentions, skills and practices related to creating and maintaining a safe sleep environment for their infants during the first four months of life; 2) describe the characteristics of physician anticipatory guidance about safe sleep and identify physician, patient and parent characteristics associated with coverage of the topic at the well-child visits; and 3) evaluate the dissemination of the B'more for Healthy Babies (BHB)'s safe sleep campaign messages and services among our study participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 28, 2017
CompletedFirst Posted
Study publicly available on registry
March 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedAugust 22, 2017
August 1, 2017
1.5 years
February 28, 2017
August 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluate the Effect of a Safe Sleep Intervention on the Safe Sleep Environment of Infants
Assessed with a 125-item questionnaire.
Follow-up #1 (3-6 weeks)
Secondary Outcomes (2)
Evaluate the Effect of a Scald Prevention Intervention on Potential Scald Risks in the Home
Follow-up #1 (3-6 weeks)
Describe Characteristics of Physician Anticipatory Guidance on Safe Sleep and Other Safety Topics
2-week well-child visit and 2-month well-child visit
Other Outcomes (1)
Evaluate Dissemination of City Health Department's Safe Sleep Campaign Messages and Services Among Participants
Baseline survey (2 weeks)
Study Arms (3)
Standard Care Study Condition
NO INTERVENTIONThe Standard of Care control group will not receive any additional services at the newborn visit.
Attention-Matched Control Condition
ACTIVE COMPARATORThe Attention-Matched Control Condition will include the Scald Prevention Intervention.
Safe Sleep Intervention Condition
EXPERIMENTALThe Intervention Condition will include the Safe Sleep Intervention.
Interventions
A health educator will visit participant during their 2-week well visit in the clinic, to deliver a tailored intervention based on the baby's sleep practices. Participant will also receive a free pack'n play, sleep sack, and educational resources on safe sleep.
A health educator will visit participant during their 2-week well visit in the clinic, to deliver a tailored intervention based on practices regarding scald risks in the home. Participant will also receive a bath thermometer, candy/frying thermometer, and educational resources on scald prevention.
Eligibility Criteria
You may qualify if:
- Adult (18 years of age) or emancipated minor.
- Parent or legal guardian of the child.
- Child is receiving care at the Harriet Lane Clinic.
- Child's primary care provider is participating in the study.
- English-speaking.
- Lives in Baltimore City or Baltimore County.
- Not homeless or not living in a shelter or in an established transitional housing facility.
You may not qualify if:
- Not an adult or emancipated minor.
- Not the parent or legal guardian of the child.
- Child is not receiving care at the Harriet Lane Clinic.
- Child's primary care provider is not participating in the study.
- Non English-speaker.
- Does not live in Baltimore City or Baltimore County.
- Homeless or living in a shelter or other established transitional housing facility.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Harriet Lane Clinic
Baltimore, Maryland, 21205, United States
Related Publications (2)
Burrell TD, McDonald EM, Mahoney P, Musci RJ, Shields W, Gielen A, Solomon BS. Content of Infant Safe Sleep Counseling and Maternal Reported Practices in an Urban Clinic. Acad Pediatr. 2019 Sep-Oct;19(7):801-807. doi: 10.1016/j.acap.2019.06.014. Epub 2019 Jun 26.
PMID: 31254631DERIVEDMcDonald EM, Davani A, Price A, Mahoney P, Shields W, Musci RJ, Solomon BS, Stuart EA, Gielen AC. Health education intervention promoting infant safe sleep in paediatric primary care: randomised controlled trial. Inj Prev. 2019 Jun;25(3):146-151. doi: 10.1136/injuryprev-2017-042421. Epub 2017 Sep 22.
PMID: 28939661DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea C Gielen, ScD, ScM
Johns Hopkins Bloomberg School of Public Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2017
First Posted
March 3, 2017
Study Start
October 1, 2015
Primary Completion
April 1, 2017
Study Completion
June 1, 2017
Last Updated
August 22, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share