Pilot Study of Novel Postpartum Educational Video Intervention

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Controlled Trial Pilot Study of the Thirty Million Words® Newborn Initiative Intervention, a Novel Postpartum Educational Video

Conditions
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Behavior, Communication, Language

Intervention / Treatment
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* Other: TMW-Newborn Intervention video
* Other: Safe Sleep for your Baby (SIDS) educational video


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Postpartum mothers admitted to the mother-baby unit. 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment intervention<br>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. | Other: TMW-Newborn Intervention video<br>* This is an educational video intervention developed by the Thirty Million Words® Initiative Lab.<br>|
| Active Comparator: Control intervention<br>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. | Other: Safe Sleep for your Baby (SIDS) educational video<br>* It is an educational video developed by the National Institute of Child Health and Development (NICHD) promoting the prevention of Sudden Infant Death Syndrome.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TMW-NI knowledge survey | Scores on the TMW-NI knowledge will be compared to pre-intervention scores. | About 24 hours post intervention | 
| Change in TMW-NI knowledge survey | Scores on the TMW-NI knowledge will be compared to pre-intervention scores. | About 4 weeks post intervention | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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achievement gap, educational intervention, language development, universal newborn hearing screening, postpartum, parental attachment, loss to follow-up, hearing loss, language gap, school readiness