Enhancing Safe Sleep Practices of Urban Low-Income Mothers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sudden Infant Death Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard Care Study Condition

The Standard of Care control group will not receive any additional services at the newborn visit.

Group Type NO_INTERVENTION

No interventions assigned to this group

Attention-Matched Control Condition

The Attention-Matched Control Condition will include the Scald Prevention Intervention.

Group Type ACTIVE_COMPARATOR

Scald Prevention Intervention

Intervention Type BEHAVIORAL

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.

Safe Sleep Intervention Condition

The Intervention Condition will include the Safe Sleep Intervention.

Group Type EXPERIMENTAL

Safe Sleep Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No