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Completed

NCT Number: NCT02267265

Pilot Study of Novel Postpartum Educational Video Intervention

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

TMW-Newborn Intervention video

Other

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

Safe Sleep for your Baby (SIDS) educational video

Other

It is an educational video developed by the National Institute of Child Health and Development (NICHD) promoting the prevention of Sudden Infant Death Syndrome.

Primary outcomes

  1. Change in TMW-NI knowledge survey

    Time frame: About 24 hours post intervention

    Scores on the TMW-NI knowledge will be compared to pre-intervention scores.

  2. Change in TMW-NI knowledge survey

    Time frame: About 4 weeks post intervention

    Scores on the TMW-NI knowledge will be compared to pre-intervention scores.

Secondary outcomes

  1. Loss to follow-up

    Time frame: About 4 weeks post intervention

    Measuring change in loss to follow-up statistics for patients that do not pass the universal newborn hearing screening.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Opinion Research Center
  • Northwestern University

Registry information

Official study title

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

Acronym: TMW-NI

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 17, 2014
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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