Enhancing Safe Sleep Practices of Urban Low-Income Mothers
- Conditions
- Sudden Infant Death Syndrome
- Registration Number
- NCT03070639
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 214
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Evaluate the Effect of a Safe Sleep Intervention on the Safe Sleep Environment of Infants Follow-up #1 (3-6 weeks) Assessed with a 125-item questionnaire.
- Secondary Outcome Measures
Name Time Method Evaluate the Effect of a Scald Prevention Intervention on Potential Scald Risks in the Home 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 2-week well-child visit and 2-month well-child visit Assessed with an 11-item coding sheet and transcription file.
Trial Locations
- Locations (1)
Harriet Lane Clinic
🇺🇸Baltimore, Maryland, United States
Harriet Lane Clinic🇺🇸Baltimore, Maryland, United States