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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

Tracking Information
First Submitted Date  ICMJE February 28, 2017
First Posted Date  ICMJE March 3, 2017
Last Update Posted Date August 22, 2017
Actual Study Start Date  ICMJE October 2015
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 28, 2017)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Enhancing Safe Sleep Practices of Urban Low-Income Mothers
Official Title  ICMJE Enhancing Safe Sleep Practices of Urban Low-Income Mothers
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Sudden Infant Death Syndrome
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Scald Prevention Intervention
  • Experimental: Safe Sleep Intervention Condition
    The Intervention Condition will include the Safe Sleep Intervention.
    Intervention: Behavioral: Safe Sleep Intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2017)
214
Original Estimated Enrollment  ICMJE
 (submitted: February 28, 2017)
546
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03070639
Other Study ID Numbers  ICMJE HD072821
1R01HD072821-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johns Hopkins Bloomberg School of Public Health
Study Sponsor  ICMJE Johns Hopkins Bloomberg School of Public Health
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Andrea C Gielen, ScD, ScM Johns Hopkins Bloomberg School of Public Health
PRS Account Johns Hopkins Bloomberg School of Public Health
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP