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Enhancing Safe Sleep Practices of Urban Low-Income Mothers

Primary Purpose

Sudden Infant Death Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safe Sleep Intervention
Scald Prevention Intervention
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sudden Infant Death Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Harriet Lane Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Standard Care Study Condition

Attention-Matched Control Condition

Safe Sleep Intervention Condition

Arm Description

The Standard of Care control group will not receive any additional services at the newborn visit.

The Attention-Matched Control Condition will include the Scald Prevention Intervention.

The Intervention Condition will include the Safe Sleep Intervention.

Outcomes

Primary Outcome Measures

Evaluate the Effect of a Safe Sleep Intervention on the Safe Sleep Environment of Infants
Assessed with a 125-item questionnaire.

Secondary Outcome Measures

Evaluate the Effect of a Scald Prevention Intervention on Potential Scald Risks in the Home
Assessed with a 45-item questionnaire.
Describe Characteristics of Physician Anticipatory Guidance on Safe Sleep and Other Safety Topics
Assessed with an 11-item coding sheet and transcription file.

Full Information

First Posted
February 28, 2017
Last Updated
August 21, 2017
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03070639
Brief Title
Enhancing Safe Sleep Practices of Urban Low-Income Mothers
Official Title
Enhancing Safe Sleep Practices of Urban Low-Income Mothers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This intervention trial uses a randomized controlled design and will be conducted in the Harriet Lane Clinic. The study conditions are: Standard Care Group (SG), Attention-Matched Control Group that receives a scald burn prevention intervention (CG), and Intervention Group that receives a safe sleep intervention (IG). Parents or legal guardians will be enrolled during the newborn visit (when the baby is approximately 4-7 days old). While waiting to be seen for their 2-week well-child visit, the parent will complete the Baseline Interview and be randomized to SG, IG, or CG. All participants will receive Standard of Care during all of their well-child visits, which will include standard anticipatory guidance delivered by the pediatric resident. The IG and CG interventions will be delivered in the clinic during the 2-week visit after the baseline survey has been completed. The first follow-up will be conducted at the home of the parent after completing the 2-week visit, when the baby is approximately 3-6 weeks old. The second follow-up will be conducted at the home of the parent after the 2-month well-child visit, when the child is approximately 2-4 months of age. Each home visit consists of an interview covering safe sleep and scald topics, an observation of the baby's sleep environment, and testing the water temperature. The 2-week and 2-month well-child visits will be audio-recorded, and parent or legal guardians will be asked to complete a Visit Exit Checklist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Infant Death Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care Study Condition
Arm Type
No Intervention
Arm Description
The Standard of Care control group will not receive any additional services at the newborn visit.
Arm Title
Attention-Matched Control Condition
Arm Type
Active Comparator
Arm Description
The Attention-Matched Control Condition will include the Scald Prevention Intervention.
Arm Title
Safe Sleep Intervention Condition
Arm Type
Experimental
Arm Description
The Intervention Condition will include the Safe Sleep Intervention.
Intervention Type
Behavioral
Intervention Name(s)
Safe Sleep Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Scald Prevention Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluate the Effect of a Safe Sleep Intervention on the Safe Sleep Environment of Infants
Description
Assessed with a 125-item questionnaire.
Time Frame
Follow-up #1 (3-6 weeks)
Secondary Outcome Measure Information:
Title
Evaluate the Effect of a Scald Prevention Intervention on Potential Scald Risks in the Home
Description
Assessed with a 45-item questionnaire.
Time Frame
Follow-up #1 (3-6 weeks)
Title
Describe Characteristics of Physician Anticipatory Guidance on Safe Sleep and Other Safety Topics
Description
Assessed with an 11-item coding sheet and transcription file.
Time Frame
2-week well-child visit and 2-month well-child visit
Other Pre-specified Outcome Measures:
Title
Evaluate Dissemination of City Health Department's Safe Sleep Campaign Messages and Services Among Participants
Description
Assessed with a 13-item questionnaire.
Time Frame
Baseline survey (2 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea C Gielen, ScD, ScM
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harriet Lane Clinic
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31254631
Citation
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.
Results Reference
derived
PubMed Identifier
28939661
Citation
McDonald 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.
Results Reference
derived

Learn more about this trial

Enhancing Safe Sleep Practices of Urban Low-Income Mothers

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