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Enhancing Safe Sleep Practices of Urban Low-Income Mothers

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ClinicalTrials.gov Identifier: NCT03070639
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : August 22, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

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.

Condition or disease Intervention/treatment Phase
Sudden Infant Death Syndrome Behavioral: Safe Sleep Intervention Behavioral: Scald Prevention Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Enhancing Safe Sleep Practices of Urban Low-Income Mothers
Actual Study Start Date : October 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard Care Study Condition
The Standard of Care control group will not receive any additional services at the newborn visit.
Active Comparator: Attention-Matched Control Condition
The Attention-Matched Control Condition will include the Scald Prevention Intervention.
Behavioral: Scald Prevention Intervention
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.

Experimental: Safe Sleep Intervention Condition
The Intervention Condition will include the Safe Sleep Intervention.
Behavioral: Safe Sleep Intervention
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.




Primary Outcome Measures :
  1. Evaluate the Effect of a Safe Sleep Intervention on the Safe Sleep Environment of Infants [ Time Frame: Follow-up #1 (3-6 weeks) ]
    Assessed with a 125-item questionnaire.


Secondary Outcome Measures :
  1. Evaluate the Effect of a Scald Prevention Intervention on Potential Scald Risks in the Home [ Time Frame: Follow-up #1 (3-6 weeks) ]
    Assessed with a 45-item questionnaire.

  2. Describe Characteristics of Physician Anticipatory Guidance on Safe Sleep and Other Safety Topics [ Time Frame: 2-week well-child visit and 2-month well-child visit ]
    Assessed with an 11-item coding sheet and transcription file.


Other Outcome Measures:
  1. Evaluate Dissemination of City Health Department's Safe Sleep Campaign Messages and Services Among Participants [ Time Frame: Baseline survey (2 weeks) ]
    Assessed with a 13-item questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070639


Locations
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United States, Maryland
Harriet Lane Clinic
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Andrea C Gielen, ScD, ScM Johns Hopkins Bloomberg School of Public Health
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT03070639    
Other Study ID Numbers: HD072821
1R01HD072821-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Infant Death
Sudden Infant Death
Death
Pathologic Processes
Death, Sudden