Clinical Trial: Enhancing Safe Sleep Practices of Urban Low-Income Mothers

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary: 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.
Sponsor: Johns Hopkins Bloomberg School of Public Health

Current Primary Outcome: 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: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Johns Hopkins Bloomberg School of Public Health

Dates:
Date Received: February 28, 2017
Date Started: October 2015
Date Completion: April 2018
Last Updated: February 28, 2017
Last Verified: February 2017