Enhancing Safe Sleep Practices of Urban Low-Income Mothers

Not Applicable

Completed

• Conditions: Sudden Infant Death Syndrome
• Interventions: Behavioral: Safe Sleep Intervention; Behavioral: Scald Prevention Intervention

• 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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2017-02-28
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-03
• Primary Completion: 2017-04
• Study Completion: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-21
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Safe Sleep Intervention Condition	Safe Sleep Intervention	The Intervention Condition will include the Safe Sleep Intervention.
Attention-Matched Control Condition	Scald Prevention Intervention	The Attention-Matched Control Condition will include the Scald Prevention Intervention.

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