Comparing Children's Books to Brochures for Safe Sleep and Infant Reading Education During Prenatal Care
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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."
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- confirmed viable pregnancy, with estimated gestational age (EGA) of at least 36 weeks at the baseline/enrollment prenatal visit,
- maternal age at least 16 years old,
- comfort speaking English during their visit and reviewing/comprehending study materials without a translator.
Exclusion criteria
Non-meeting the above.
Trial design
Primary purpose
Allocation
Interventional model
Masking
144 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal