Clinical trial NCT02376673: Comparing Children's Book to Brochures for Safe Sleep Education in a Home Visiting Program
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sudden Infant Death Syndrome (SIDS)
Keywords: Pediatric Health Literacy
Home Literacy Orientation
safe sleep
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: de Cavel Family SIDS Foundation
name: Every Child Succeeds
First posted: 2015-03-03
Enrollment: 282
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change In Maternal Safe Sleep Knowledge
timeFrame: Prenatal baseline to 1 week and 2 months postnatally
measure: Assessment of Infant Sleep Environment
timeFrame: During study home visits 1 week and 2 months postnatally
measure: Maternal Impression of Safe Sleep Materials Provided
timeFrame: At study home visits 1 week and 2 months postnatally
measure: Home Visitor Impression of Safe Sleep Materials Provided
timeFrame: At each study home visit: prenatal, 1 week, and 2 months postnatally
Secondary outcomes:
measure: Maternal Health Literacy Screen
timeFrame: One time prenatally
measure: Change in Home Literacy Orientation
timeFrame: Baseline prenatally and 2 months postnatally
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
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