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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02267265
Other study ID # TMW-NI
Secondary ID
Status Completed
Phase N/A
First received September 11, 2014
Last updated December 4, 2017
Start date September 2015
Est. completion date December 2016

Study information

Verified date December 2017
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 694
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
TMW-Newborn Intervention video
This is an educational video intervention developed by the Thirty Million Words® Initiative Lab.
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.

Locations

Country Name City State
United States Northwestern Memorial Hospital Chicago Illinois
United States The University of Chicago Medicine Chicago Illinois

Sponsors (3)

Lead Sponsor Collaborator
University of Chicago National Opinion Research Center, Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in TMW-NI knowledge survey Scores on the TMW-NI knowledge will be compared to pre-intervention scores. About 24 hours post intervention
Primary 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 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
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