Comparing Children's Book to Brochures for Safe Sleep Education in a Home Visiting Program
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|ClinicalTrials.gov Identifier: NCT02376673|
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : February 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sudden Infant Death Syndrome (SIDS)||Other: Children's Book Other: Standard Brochures||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||282 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||June 2014|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||March 2016|
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.
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 Name: Sleep Baby, Safe and Snug
- 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.
- 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
- 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.
- 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.
- Maternal Health Literacy Screen [ Time Frame: One time prenatally ]Maternal health literacy screen using the validated REALM-R measure (recognizing and pronouncing medical words)
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376673
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|