Pilot Study of Novel Postpartum Educational Video Intervention

Not Applicable

Completed

• Conditions: Language; Behavior; Communication
• Interventions: Other: Safe Sleep for your Baby (SIDS) educational video; Other: TMW-Newborn Intervention video

• Registration Number: NCT02267265
• Lead Sponsor: University of Chicago

Brief Summary

A child's early language environment is pivotal for language development. Disparities in early language environments contribute to the gap in school readiness between poor and more advantaged children. Ultimately this leads to disparities in students' school achievement and economic outcomes. While recent research has highlighted the value of early intervention for children in disadvantaged families, most existing interventions begin too late, reach only a small proportion of children at risk, and do not capitalize on the critical role that parent language plays in a child's educational trajectory. To address this challenge, the investigators propose to develop and evaluate a novel language-based, perinatal public health intervention, Thirty Million Words Newborn Initiative (TMW-NI). It is proposed that new mothers will receive this educational intervention while their babies are undergoing the universal newborn hearing screen. The intervention will use video, animation, and interactive questions to convey the importance of the early language environment and to illustrate strategies parents can use to promote language learning. The investigators will conduct formative research with mothers of low socioeconomic status (low-SES) and with healthcare providers to inform the content and format of the intervention prototype. Also critical for acceptability, the investigators will use an iterative approach to develop the intervention, with review of the work-in-progress by the intended audience. To assess feasibility and initial efficacy, the investigators will conduct a randomized-controlled trial with low-SES mothers during the newborn period. The investigators hypothesize that TMW-NI will positively impact parents' knowledge and beliefs about the role of language input for a child's language development.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-10-13
• Study First Posted: 2014-10-17
• Study Start: 2015-09
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 694

Inclusion Criteria

-Postpartum mothers admitted to the mother-baby unit.

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Exclusion Criteria

• Mothers of infants who were admitted to the neonatal intensive care unit (NICU).
• Mothers who experienced any serious medical complications during birth.
• Mothers who do not expect to reside in Illinois for the duration of the study (approximately two months).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control intervention	Safe Sleep for your Baby (SIDS) educational video	The control group will complete a demographics questionnaire and knowledge survey. Participants will subsequently view the 10-minute Safe Sleep for your Baby (SIDS) educational video. It is an educational video developed by the National Institute of Child Health and Development (NICHD) promoting the prevention of Sudden Infant Death Syndrome. This will be around the time of the newborn hearing screening. Participants will complete the knowledge survey again before discharge, and after approximately four to six weeks.
Treatment intervention	TMW-Newborn Intervention video	The treatment group will complete a demographics questionnaire and the knowledge survey before the intervention. Participants will then view the 10 minute TMW-Newborn Intervention video around the time of the newborn hearing screening. Participants whose newborn does not pass the hearing screen will view an additional 3 minute video detailing the importance of following up for an outpatient re-screening. The participant will complete the knowledge survey again before discharge, and after approximately four to six weeks.

Primary Outcome Measures

Name	Time	Method
Change in TMW-NI knowledge survey	About 4 weeks post intervention	Scores on the TMW-NI knowledge will be compared to pre-intervention scores.

Secondary Outcome Measures

Name	Time	Method
Loss to follow-up	About 4 weeks post intervention	Measuring change in loss to follow-up statistics for patients that do not pass the universal newborn hearing screening.

Trial Locations

Locations (2)

The University of Chicago Medicine; 🇺🇸 Chicago, Illinois, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States