Pilot Study of Novel Postpartum Educational Video Intervention

Communication Clinical Trial

— TMW-NI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267265
• Other study ID #: TMW-NI
• 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
• 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).

Related Conditions & MeSH terms

• Behavior
• Communication
• Language

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