CompletedNot Applicable

Comparing Children's Book to Brochures for Safe Sleep Education in a Home Visiting Program

United States282 participantsStarted 2014-06

Plain-language 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.

Who can participate

Age range

15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change In Maternal Safe Sleep Knowledge

Timeframe: Prenatal baseline to 1 week and 2 months postnatally

Assessment of Infant Sleep Environment

Timeframe: During study home visits 1 week and 2 months postnatally

Maternal Impression of Safe Sleep Materials Provided

Timeframe: At study home visits 1 week and 2 months postnatally

Home Visitor Impression of Safe Sleep Materials Provided

Timeframe: At each study home visit: prenatal, 1 week, and 2 months postnatally

Trial details

NCT IDNCT02376673

SponsorChildren's Hospital Medical Center, Cincinnati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-01

View on ClinicalTrials.gov More Sudden Infant Death Syndrome (SIDS) trials