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

August 5, 2021 updated by: Children's Hospital Medical Center, Cincinnati

A Randomized Controlled Trial Comparing a Children's Book to Brochures for Safe Sleep Education in an At-Risk Population Enrolled in a Home Visitation Program

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Safe sleep and health literacy are priorities at national, state, and local levels. While greatly improved since the launch of the Back to Sleep campaign in the 1990s, the rate of sleep-related infant deaths, notably Sudden Infant Death Syndrome (SIDS), has been stagnant for over a decade. While printed materials are widely distributed for SIDS education, to date none have been proven effective, and overall satisfaction has been low. Reasons include passive delivery, unappealing content, and excessively high reading level, especially for low-socioeconomic status populations. Evidence suggests that an ideal strategy involves printed materials combining simplicity, emotional appeal, cultural sensitivity, and low reading level, conveyed by health care practitioners and reviewed multiple times. Children's books are a potentially ideal medium for this, combining pictures and text to invoke emotion and inspire a shared parent-child experience that is valued and repeated.

This is a randomized controlled trial involving a population of at-risk, low-socioeconomic status, first-time mothers enrolled in an early intervention home visitation program, Every Child Succeeds (ECS). ECS home visitors from 9 agencies will be randomly assigned to utilize either a specially-designed children's book (intervention) or standard brochures (control) for safe sleep education. Our target enrollment is 230 mothers. Trained ECS home visitors will obtain consent, distribute the book or brochures, and perform baseline assessment of health literacy (via the REALM-R screen), safe sleep knowledge, and home literacy orientation during a third trimester, prenatal home visit. Outcomes data will be collected by the same visitor during subsequent home visits at 1 week old, when infant sleep routines are being established, and 2 months old, at onset of peak SIDS risk. At each visit, the book or brochures will be reviewed.

Outcomes will be compared between intervention and control groups in the following categories: 1) maternal safe sleep knowledge, 2) maternal adherence to safe sleep guidelines (observed), 3) maternal and provider satisfaction with materials utilized to convey safe sleep guidelines, and 4) the degree to which utilizing a children's book for health education impacts home literacy orientation (i.e. attitudes towards reading).

Study Type

Interventional

Enrollment (Actual)

282

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Prenatal enrollment in the Every Child Succeeds home visitation program,
  • English speaking (intervention book was not available in Spanish), and
  • at least 15 years old.

Exclusion Criteria:

  • Non-English speaking,
  • age under 15 years,
  • delayed hospital discharge such that an initial postnatal home visit prior to 3 weeks old is not possible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Brochures
Mothers in this arm will receive safe sleep education from home visitors using standard brochures (including 1-page handouts and pamphlets) that are customarily used in this home visiting program.
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.
Other Names:
  • What does a safe sleep environment look like?
  • Bright Futures - Newborn Visit
  • Home Safe Home - Sleep
  • Helping Baby Back to Sleep
  • Sleep and your 1-3 month-old
Experimental: Children's Book
Mothers in this arm will receive safe sleep education from home visitors using a specially-designed children's book incorporating American Academy of Pediatrics safe sleep guidelines.
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 Names:
  • Sleep Baby, Safe and Snug

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change In Maternal Safe Sleep Knowledge
Time Frame: Prenatal baseline to 1 week and 2 months postnatally
Change in maternal knowledge of safe sleep recommendations (per American Academy of Pediatrics) from a baseline collected prenatally, to outcomes measured at approximately 1 week and then 2 months postnatally.
Prenatal baseline to 1 week and 2 months postnatally
Assessment of Infant Sleep Environment
Time Frame: During study home visits 1 week and 2 months postnatally
Direct assessment in the home of infant sleep environment and maternal adherence to American Academy of Pediatrics safe sleep recommendations via the home visitor at approximately 1 week and then 2 months postnatally
During study home visits 1 week and 2 months postnatally
Maternal Impression of Safe Sleep Materials Provided
Time Frame: At study home visits 1 week and 2 months postnatally
Maternal impression of printed materials (book or brochures) used for safe sleep teaching, content and usefulness.
At study home visits 1 week and 2 months postnatally
Home Visitor Impression of Safe Sleep Materials Provided
Time Frame: At each study home visit: prenatal, 1 week, and 2 months postnatally
Home visitor impression of printed materials (book or brochures) used for safe sleep teaching, time of delivery and usefulness.
At each study home visit: prenatal, 1 week, and 2 months postnatally

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Health Literacy Screen
Time Frame: One time prenatally
Maternal health literacy screen using the validated REALM-R measure (recognizing and pronouncing medical words)
One time prenatally
Change in Home Literacy Orientation
Time Frame: Baseline prenatally and 2 months postnatally
Change is assessed via six questions concerning planned or current shared reading frequency, children's books in the home, and attitudes towards shared reading, as well as attitudes towards and frequency of television use.
Baseline prenatally and 2 months postnatally

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Every Child Succeeds
de Cavel Family SIDS Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 19, 2015

First Submitted That Met QC Criteria

February 25, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Actual)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CincinnatiChildrens

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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