Pilot Study of Novel Postpartum Educational Video Intervention (TMW-NI)

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

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 Overview

• Status: Completed
• Conditions: Communication; Behavior; Language
• Intervention / Treatment: Other: TMW-Newborn Intervention video; Other: Safe Sleep for your Baby (SIDS) educational video

• Study Type: Interventional
• Enrollment (Actual): 694
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment intervention; The treatment group will complete a demographics questionnaire and the knowledge survey before the intervention. Participants will then view the 10 minute TMW-Newborn Intervention video around the time of the newborn hearing screening. Participants whose newborn does not pass the hearing screen will view an additional 3 minute video detailing the importance of following up for an outpatient re-screening. The participant will complete the knowledge survey again before discharge, and after approximately four to six weeks.	Other: TMW-Newborn Intervention video; This is an educational video intervention developed by the Thirty Million Words® Initiative Lab.
Active Comparator: Control intervention; The control group will complete a demographics questionnaire and knowledge survey. Participants will subsequently view the 10-minute 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. This will be around the time of the newborn hearing screening. Participants will complete the knowledge survey again before discharge, and after approximately four to six weeks.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in TMW-NI knowledge survey	Scores on the TMW-NI knowledge will be compared to pre-intervention scores.	About 24 hours post intervention
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: Northwestern University; National Opinion Research Center
• Investigators: Principal Investigator: Dana Suskind, MD, The University of Chicago Medicine; Study Chair: Kristin Leffel, AB, The University of Chicago Medicine

Publications and helpful links

General Publications

• Sowa LE, Thomas JMN, Hundertmark AC, Baroody FM, Suskind DL. Leveraging the universal newborn hearing screen to impact parental knowledge of childhood speech development in low socioeconomic populations: A randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2021 Jul;146:110763. doi: 10.1016/j.ijporl.2021.110763. Epub 2021 May 11.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: September 11, 2014
• First Submitted That Met QC Criteria: October 13, 2014
• First Posted (Estimate): October 17, 2014

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: December 4, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: postpartum; hearing loss; educational intervention; language development; parental attachment; achievement gap; language gap; school readiness; loss to follow-up; universal newborn hearing screening
• Other Study ID Numbers: TMW-NI