NCT03366831

Brief Summary

The purpose of the proposed research is to perform testing of the Thirty Million Words Newborn Initiative (TMW-NI) with the primary goal of evaluating various implementation methods. The investigators hypothesize that the TMW-Newborn intervention will:

  1. 1.Significantly impact parent knowledge regarding the importance of universal newborn hearing screen (UNHS) follow-up
  2. 2.Significantly impact parent knowledge of child development
  3. 3.The 7-minute version of the video with questions interspersed will most significantly improve parent knowledge of child development
  4. 4.There will be no significant differences in effectiveness of the Spanish and English versions of the TMW-Newborn intervention

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,701

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2019

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

2.6 years

First QC Date

December 4, 2017

Last Update Submit

May 9, 2023

Conditions

Language Development

Outcome Measures

Primary Outcomes (1)

  • SPEAK Survey (Baby Subscales)

    measures an individuals expectations and knowledge about child development

    48-72 after routine delivery

Study Arms (4)

15 minute version without questions

ACTIVE COMPARATOR

15 minute version of the TMW-Newborn intervention video without questions interspersed

Behavioral: Thirty Million Words Initiative Newborn Intervention

15 minute version with questions

ACTIVE COMPARATOR

15 minute version of the TMW-Newborn intervention video with questions interspersed

Behavioral: Thirty Million Words Initiative Newborn Intervention

7 minute version without questions

ACTIVE COMPARATOR

7 minute version of the TMW-Newborn intervention video without questions interspersed

Behavioral: Thirty Million Words Initiative Newborn Intervention

7 minute version with questions

ACTIVE COMPARATOR

7 minute version of the TMW-Newborn intervention video with questions interspersed.

Behavioral: Thirty Million Words Initiative Newborn Intervention

Interventions

Thirty Million Words Initiative Newborn InterventionBEHAVIORAL

The Thirty Million Words Initiative Newborn Intervention (TMW-Newborn) is a public health effort aimed at increasing awareness about the importance of a child's early language environment in his or her first years of life. This one-time educational intervention will be impacting maternal awareness and knowledge about the importance of children's early language environment, between ages 0 and 3.

15 minute version with questions15 minute version without questions7 minute version with questions7 minute version without questions

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsnew mothers
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • New mothers at Sacred Heart Hospital, University of Chicago Medical Center, and Baptist Hospital-Pensacola.

You may not qualify if:

  • Individuals that do not have a live birth at Sacred Heart Hospital, University of Chicago Medical Center, or Baptist Hospital-Pensacola or do not receive the UNHS at one of these locations will not be eligible for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sacred Heart Hospital

Pensacola, Florida, 19141, United States

Location

Baptist Hospital

Pensacola, Florida, 32501, United States

Location

TMW Center for Early Learning + Public Health at the University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • Suskind DL, Leung CYY, Webber RJ, Hundertmark AC, Leffel KR, Fuenmayor Rivas IE, Grobman WA. Educating Parents About Infant Language Development: A Randomized Controlled Trial. Clin Pediatr (Phila). 2018 Jul;57(8):945-953. doi: 10.1177/0009922817737079. Epub 2017 Oct 26.

    PMID: 29073768BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2017

First Posted

December 8, 2017

Study Start

April 10, 2017

Primary Completion

November 6, 2019

Study Completion

November 6, 2019

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

IPD will not be shared

Locations

US(3)