Enhancing Safe Sleep Practices of Urban Low-Income Mothers

Sudden Infant Death Syndrome Clinical Trial

Official title:

Enhancing Safe Sleep Practices of Urban Low-Income Mothers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03070639
• Other study ID #: HD072821
• Secondary ID: 1R01HD072821-01A
• Status: Completed
• Phase: N/A
• First received: February 28, 2017
• Last updated: August 21, 2017
• Start date: October 2015
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infant Death
• Sudden Infant Death
• Sudden Infant Death Syndrome

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.
• 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.

Locations

Country	Name	City	State
United States	Harriet Lane Clinic	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate Dissemination of City Health Department's Safe Sleep Campaign Messages and Services Among Participants	Assessed with a 13-item questionnaire.	Baseline survey (2 weeks)
Primary	Evaluate the Effect of a Safe Sleep Intervention on the Safe Sleep Environment of Infants	Assessed with a 125-item questionnaire.	Follow-up #1 (3-6 weeks)
Secondary	Evaluate the Effect of a Scald Prevention Intervention on Potential Scald Risks in the Home	Assessed with a 45-item questionnaire.	Follow-up #1 (3-6 weeks)
Secondary	Describe Characteristics of Physician Anticipatory Guidance on Safe Sleep and Other Safety Topics	Assessed with an 11-item coding sheet and transcription file.	2-week well-child visit and 2-month well-child visit