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Completed

NCT Number: NCT03070639

Enhancing Safe Sleep Practices of Urban Low-Income Mothers

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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Key information

Conditions

Sudden Infant Death Syndrome Death Death, Sudden Infant Death Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Infant Death

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harriet Lane Clinic

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Safe Sleep Intervention

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.

Scald Prevention Intervention

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. Evaluate Dissemination of City Health Department's Safe Sleep Campaign Messages and Services Among Participants

    Time frame: Baseline survey (2 weeks)

    Assessed with a 13-item questionnaire.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 3, 2017
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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