Comparing Children's Books to Brochures for Safe Sleep and Infant Reading Education During Prenatal Care

A Randomized Controlled Trial Comparing a Children's Book to Brochures for Safe Sleep and Infant Reading Education During Prenatal Obstetric Visits

The aim of this randomized trial is to compare a specially designed children's book to brochures for safe sleep education via clinical providers at a third trimester prenatal obstetric visit. Mothers in the control group will receive a specially designed children's book regarding the importance of reading with their infant at this visit, compared to brochures. Knowledge of safe sleep and home literacy orientation will be assessed at baseline prenatally, and their first postpartum obstetric visit.

Study Overview

• Status: Completed
• Conditions: Sudden Unexplained Infant Death; Child Rearing; Literacy
• Intervention / Treatment: Behavioral: Sleep Baby, Safe and Snug; Behavioral: Read Baby, Every Day

Detailed Description

This study is a randomized controlled trial (RCT) involving 2 groups of pregnant women from low-socioeconomic status (SES) backgrounds at-risk for adverse cognitive and health outcomes for their infant. Mothers will be randomly assigned to intervention and control groups during a third-trimester prenatal visit at a hospital-affiliated obstetric clinic, via convenience sampling. Mothers in the intervention group will receive education on American Academy of Pediatrics (AAP) safe sleep recommendations using a specially-designed children's book (Sleep Baby, Safe and Snug), while those in the control group will receive this guidance via a brochure endorsed by the AAP.

In a "mirror" design, mothers in the control group will receive guidance on reading with their infant using a specially designed children's book (Read Baby, Every Day), and mothers in the intervention group will receive guidance on reading with their infant using a brochure created and endorsed by the AAP.

Clinical research coordinators (CRCs) will obtain consent and collect data at two time points: 1) a 3rd trimester prenatal visit (approximately 36-38 weeks estimated gestational age; baseline), and 2) at the first, regularly scheduled postpartum visit (4-6 weeks after delivery for an uncomplicated vaginal delivery, and 2 weeks for cesarean section). Data will be collected in 4 categories, which will be compared between groups: 1) demographics, 2) maternal knowledge of AAP safe sleep recommendations, 3) maternal attitudes about reading with infants, 4) maternal impression of the printed educational materials provided, and 4) clinician impression of the feasibility and usefulness of the printed materials provided for obstetric prenatal care.

Educational materials will be shared with mothers by obstetric providers (obstetric attending physicians and residents) during this visit, who will be provided with a brief summary of content and to conduct the visit as they see fit. Mothers will be blinded to the aims of the study, other than that it is to "share information about safe sleep and reading with your baby."

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • University of Cincinnati Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. confirmed viable pregnancy, with estimated gestational age (EGA) of at least 36 weeks at the baseline/enrollment prenatal visit,
2. maternal age at least 16 years old,
3. comfort speaking English during their visit and reviewing/comprehending study materials without a translator.

Exclusion Criteria:

Non-meeting the above.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safe Sleep Education; Mothers in the intervention group will receive education on American Academy of Pediatrics safe sleep recommendations using a specially-designed children's book (Sleep Baby, Safe and Snug). In addition, they will receive information on the importance of reading with their infant using a brochure created by the AAP.	Behavioral: Sleep Baby, Safe and Snug; Specially designed children's book, 14 pages, rhyming, illustrated in color, written at a Kindergarten reading level. Each page spread highlights AAP-recommended safe sleep practices. AAP safe sleep recommendations listed on the back cover.
Active Comparator: Infant Reading Education; Mothers in the control group will receive education on American Academy of Pediatrics recommendations on reading and talking to infants using a specially-designed children's book (Read Baby, Every Day). In addition, they will receive information on safe sleep using a brochure created by the AAP.	Behavioral: Read Baby, Every Day; Specially designed children's book, 14 pages, rhyming, illustrated in color, written at a Kindergarten reading level. Each page spread highlights AAP-recommendations regarding the importance of reading and talking to infants. Recommendations and benefits of reading with infants are listed on the back cover as well.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safe Sleep Knowledge	The safe sleep assessment is based on a version developed by the PI and used in a recent published study, reflecting current AAP guidelines. Three questions are adapted from a published survey, gauging the mother's familiarity with SUID/SIDS (and briefly explaining if unfamiliar), whether she personally knows anyone who has lost a child to SUID/SIDS, and level of worry about SUID/SIDS for her baby. Our primary knowledge question utilizes an open-ended format, as no established tool for measuring SIDS knowledge was available: "Name as many things as you can think of to help keep your baby safe from SUID/SIDS (dying while asleep)." Maternal responses will be compared to an 11-item checklist of AAP safe sleep recommendations which are each referenced at least once in the book and brochures used, with 1 point awarded for each correct response.	Baseline prenatal (>= 32 weeks) and postpartum (<= 6 weeks).
Maternal impression of educational materials	Mothers will be administered a brief survey (Likert scale) regarding how useful the respective book or brochure were to help them understand safe sleep practices and the importance of infant reading. They will also be asked if they still have the materials and how often they have reviewed them at home.	Postpartum (<= 6 weeks)
Clinical provider impression of educational materials	Obstetric attending and resident physicians will be administered a brief survey (Likert scale) after the prenatal visit regarding how useful the respective book or brochure was to catalyze discussion of safe sleep and infant reading with the mother, with emphasis on feasibility in clinical practice.	Prenatal/baseline visit (>=32 weeks gestation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home Literacy Orientation	Prenatally, the mother will be administered a brief survey regarding the age at which the mother plans to begin reading with her infant (open-ended), planned frequency of reading (days per week), estimated number of children's books in the home, impression of the usefulness of reading to infants before 2 months old, and the value of discussing reading during prenatal visits (Likert scales). At the postpartum visit, this survey will be expanded to involve access to books, actual reading frequency, home reading routines, and the child's interest in being read to. An additional item regarding attitudes towards reading at home adapted from published research ("What are your 3 favorite things to do with your child these days?", noting if reading is mentioned) will also be asked.	Baseline prenatal (>= 32 weeks) and postpartum (<= 6 weeks).
DialogPR-I/T	This is an 10-item parental report assessment of shared reading quality created by the principal investigator for caregivers of children under 18 months, based on a conceptual model of practices thought to enhance the reading experience and benefit child development. Score is 0-30 points, with higher score suggesting more nurturing reading behaviors.	Postpartum (<= 6 weeks).

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: University of Cincinnati

Publications and helpful links

General Publications

• Hutton JS, Gupta R, Gruber R, Berndsen J, DeWitt T, Ollberding NJ, Van Ginkel JB, Ammerman RT. Randomized Trial of a Children's Book Versus Brochures for Safe Sleep Knowledge and Adherence in a High-Risk Population. Acad Pediatr. 2017 Nov-Dec;17(8):879-886. doi: 10.1016/j.acap.2017.04.018. Epub 2017 Apr 24.
• Hutton JS, Lin L, Gruber R, Berndsen J, DeWitt T, Van Ginkel JB, Ammerman RT. Shared Reading and Television Across the Perinatal Period in Low-SES Households. Clin Pediatr (Phila). 2018 Jul;57(8):904-912. doi: 10.1177/0009922817737077. Epub 2017 Oct 25.
• Hutton JS, Huang G, Crosh C, DeWitt T, Ittenbach RF. Shared reading with infants: SharePR a novel measure of shared reading quality. Pediatr Res. 2022 Jul 19. doi: 10.1038/s41390-022-02178-6. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2019
• Primary Completion (Actual): January 15, 2020
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: February 16, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 24, 2019

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

• Additional Relevant MeSH Terms: Pathologic Processes; Death; Infant Death
• Other Study ID Numbers: 2018-5564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Available in a de-identified fashion by written request & approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No