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

NCT02376673 | Completed

• 1 other identifier: CincinnatiChildrens
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Pediatric Health Literacy; Home Literacy Orientation; safe sleep

Outcome Measures

Primary Outcomes (4)

• Change In Maternal Safe Sleep Knowledge

  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

  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

  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

  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 Outcomes (2)

• Maternal Health Literacy Screen

  One time prenatally

• Change in Home Literacy Orientation

  Baseline prenatally and 2 months postnatally

Study Arms (2)

Brochures

ACTIVE COMPARATOR

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

Children's Book

EXPERIMENTAL

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

Interventions

Children's Book OTHER

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.

Also known as: Sleep Baby, Safe and Snug

Children's Book

Standard Brochures OTHER

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

Also known as: 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

Brochures

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• de Cavel Family SIDS Foundation: collaborator
• Every Child Succeeds: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

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MeSH Terms

Conditions

Sudden Infant Death

Interventions

Sleep

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: March 3, 2015
• Study Start: June 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: August 9, 2021

Record last verified: 2021-08

Locations

US (1)