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

Literacy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04031235
• Other study ID #: 2018-5564
• Status: Completed
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: August 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Child Rearing
• Infant Death
• Literacy
• Sudden Unexplained Infant Death

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	University of Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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)
Primary	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	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).
Secondary	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).