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Comparing Children's Book to Brochures for Safe Sleep Education in a Home Visiting Program

NCT02376673 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2021-08-09

No results posted yet for this study

Summary

This randomized controlled trial compares a specially-designed children's book to standard brochures for safe sleep education and reduction of Sudden Infant Death Syndrome (SIDS) risk in a high-risk population of young, first-time mothers enrolled in a home visitation program. Roughly half of the mothers will receive safe sleep education via the book, the other half via brochures, during prescribed home visits. Our study will assess differences in safe sleep knowledge, adherence to recommendations, satisfaction with materials used, and attitudes towards reading with their baby. Our hypothesis is that these will be higher in the group receiving the book, due to simpler language, appealing illustrations, emotional connection, and repeated exposures via shared reading.

Conditions

  • Sudden Infant Death Syndrome (SIDS)

Interventions

OTHER

Children's Book

A specially-designed, illustrated (full color) children's book written at a first-grade level, conveying American Academy of Pediatrics safe sleep guidelines through the story. Expanded guidelines are listed on the back cover, at a 4th grade reading level. This book will be exclusively used for safe sleep education at 3 study home visits: prenatal between 32 weeks and term, 1 week postnatal, and 2 months postnatal. The mother will be encouraged to share the book with her baby.

OTHER

Standard Brochures

An assortment of standard safe sleep educational brochures provided by home visitors during prescribed home visits, covering various recommendations for safe sleep.

Sponsors & Collaborators

  • de Cavel Family SIDS Foundation

    collaborator UNKNOWN

  • Every Child Succeeds

    collaborator UNKNOWN

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-01-31
Completion
2016-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02376673 on ClinicalTrials.gov