Clinical trial NCT02267265: Pilot Study of Novel Postpartum Educational Video Intervention
Official title: A Randomized Controlled Trial Pilot Study of the Thirty Million Words® Newborn Initiative Intervention, a Novel Postpartum Educational Video
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Communication
Language
Keywords: educational intervention
language development
universal newborn hearing screening
postpartum
parental attachment
loss to follow-up
hearing loss
achievement gap
language gap
school readiness
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Opinion Research Center
name: Northwestern University
First posted: 2014-10-17
Enrollment: 694
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in TMW-NI knowledge survey
timeFrame: About 24 hours post intervention
measure: Change in TMW-NI knowledge survey
timeFrame: About 4 weeks post intervention
Secondary outcomes:
measure: Loss to follow-up
timeFrame: About 4 weeks post intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medicine
state: Illinois
Study officials:
affiliation: The University of Chicago Medicine
name: Dana Suskind, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Chicago Medicine
name: Kristin Leffel, AB
role: STUDY_CHAIR
References:
citation: 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.