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Clinical Trials/NCT02267265
NCT02267265
Completed
Not Applicable

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

University of Chicago2 sites in 1 country694 target enrollmentStarted: September 2015Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
694
Locations
2
Primary Endpoint
Change in TMW-NI knowledge survey

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts 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).

Outcomes

Primary Outcomes

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

  • Loss to follow-up(About 4 weeks post intervention)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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