An interventional study of Thirty Million Words Initiative Newborn Intervention in Language Development, sponsored by University of Chicago. Completed at 3 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-10.
Sponsored by University of Chicago · Not applicable, Interventional, and Other
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:
Significantly impact parent knowledge of child development
Additionally,the investigators hypothesize that:
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.
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.
243 studies on the registry are indexed under Language; 76 are open to participants now.
This study's enrollment of 2,701 is above the median of 65 across 158 interventional studies indexed under Language.
Browse Language studies →University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
New mothers at Sacred Heart Hospital, University of Chicago Medical Center, and Baptist Hospital-Pensacola.
Exclusion Criteria:
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.
15 minute version of the TMW-Newborn intervention video without questions interspersed
Behavioral: Thirty Million Words Initiative Newborn Intervention
15 minute version of the TMW-Newborn intervention video with questions interspersed
Behavioral: Thirty Million Words Initiative Newborn Intervention
7 minute version of the TMW-Newborn intervention video without questions interspersed
Behavioral: Thirty Million Words Initiative Newborn Intervention
7 minute version of the TMW-Newborn intervention video with questions interspersed.
Behavioral: Thirty Million Words Initiative Newborn Intervention
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.
SPEAK Survey (Baby Subscales)
measures an individuals expectations and knowledge about child development
Time frame: 48-72 after routine delivery
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — IPD will not be shared
Ran from Apr 2017 to primary completion in Nov 2019, 30 months.
Of 89 non-industry interventional studies with no phase under Language, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 64. This study's 30 months is close to that.
Counting every sponsor, half of 93 studies reached it within 33 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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