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

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ClinicalTrials.gov Identifier: NCT02267265
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : December 6, 2017
Sponsor:
Collaborators:
National Opinion Research Center
Northwestern University
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Behavior Communication Language Other: TMW-Newborn Intervention video Other: Safe Sleep for your Baby (SIDS) educational video Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 694 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: A Randomized Controlled Trial Pilot Study of the Thirty Million Words® Newborn Initiative Intervention, a Novel Postpartum Educational Video
Actual Study Start Date : September 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

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.




Primary Outcome Measures :
  1. Change in TMW-NI knowledge survey [ Time Frame: About 24 hours post intervention ]
    Scores on the TMW-NI knowledge will be compared to pre-intervention scores.

  2. Change in TMW-NI knowledge survey [ Time Frame: About 4 weeks post intervention ]
    Scores on the TMW-NI knowledge will be compared to pre-intervention scores.


Secondary Outcome Measures :
  1. Loss to follow-up [ Time Frame: About 4 weeks post intervention ]
    Measuring change in loss to follow-up statistics for patients that do not pass the universal newborn hearing screening.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267265


Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
The University of Chicago Medicine
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
National Opinion Research Center
Northwestern University
Investigators
Principal Investigator: Dana Suskind, MD The University of Chicago Medicine
Study Chair: Kristin Leffel, AB The University of Chicago Medicine

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02267265     History of Changes
Other Study ID Numbers: TMW-NI
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

Keywords provided by University of Chicago:
educational intervention
language development
universal newborn hearing screening
postpartum
parental attachment
loss to follow-up
hearing loss
achievement gap
language gap
school readiness