Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03366831 |
| Other study ID # |
17-0329 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 10, 2017 |
| Est. completion date |
November 6, 2019 |
Study information
| Verified date |
May 2023 |
| Source |
University of Chicago |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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. Significantly impact parent knowledge regarding the importance of universal newborn
hearing screen (UNHS) follow-up
2. Significantly impact parent knowledge of child development
Additionally,the investigators hypothesize that:
3. The 7-minute version of the video with questions interspersed will most significantly
improve parent knowledge of child development
4. There will be no significant differences in effectiveness of the Spanish and English
versions of the TMW-Newborn intervention
The hypotheses rely on the existing research data supporting the idea that parental
understanding and beliefs will alter parental behavior, and consequently, that increased
parental linguistic input will impact child cognitive development.
Description:
The investigators propose to perform a randomized implementation trial to evaluate the
efficacy of various implementation methods of the TMW-Newborn educational intervention. The
study will be conducted in temporal proximity to the administration of the universal newborn
hearing screen.
After routine delivery, postpartum mothers are admitted to the mother-baby unit for 48-72
hours. A hearing screening technician of the Sacred Heart Hospital will deliver the tablet
that houses the intervention to every mother whose child is receiving the hearing screening.
The technician will give each mother a tablet set up to the HIPAA Compliant TMW-Newborn Web
Platform that houses the randomization tool, the welcome video, the tablet based consent
passage, the surveys, and the educational intervention videos. First, the participant will
watch the welcome video and complete the tablet based consent. Then, the participant will be
randomized into one of four conditions: 15 minute version of the TMW-Newborn intervention
video without questions interspersed, the 15 minute version of the TMW-Newborn intervention
video with questions interspersed, the 7 minute version of the TMW-Newborn intervention video
without questions interspersed, or the 7 minute version of the TMW-Newborn intervention video
with questions interspersed.
After randomization, the participant will be brought to the screen with the SPEAK III to
complete. Then, they will answer a few non-identifying demographics questions. These surveys
takes approximately 10 minutes to complete will be followed by either a 15-minute or 7-minute
video.
After watching their assigned video, all participants will repeat the SPEAK questionnaire for
a second time. Then, the hearing screener will pick up the tablet from the participant. No
identifying information is being collected within the TMW-Newborn web platform, and the
hearing screening technicians will not be able to see or access any of the participants'
responses.
After all surveys are complete, the hearing screening technician will pick up the tablet from
the participant and answer any remaining questions.
This study protocol will only be used at Sacred Heart Hospital, Baptist Hospital, and
University of Chicago Hospital.
