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Pilot Study of Novel Postpartum Educational Video Intervention

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02267265
Acronym
TMW-NI
Enrollment
694
Registered
2014-10-17
Start date
2015-09-30
Completion date
2016-12-31
Last updated
2017-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavior, Communication, Language

Keywords

educational intervention, language development, universal newborn hearing screening, postpartum, parental attachment, loss to follow-up, hearing loss, achievement gap, language gap, school readiness

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.

Interventions

OTHERTMW-Newborn Intervention video

This is an educational video intervention developed by the Thirty Million Words® Initiative Lab.

OTHERSafe 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.

Sponsors

National Opinion Research Center
CollaboratorOTHER
Northwestern University
CollaboratorOTHER
University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Change in TMW-NI knowledge surveyAbout 24 hours post interventionScores on the TMW-NI knowledge will be compared to pre-intervention scores.

Secondary

MeasureTime frameDescription
Loss to follow-upAbout 4 weeks post interventionMeasuring change in loss to follow-up statistics for patients that do not pass the universal newborn hearing screening.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026