Pilot Study of Novel Postpartum Educational Video Intervention

NCT02267265 | Completed

• 1 other identifier: TMW-NI
• Study Type: interventional
• Target: 694
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• Change in TMW-NI knowledge survey

  Scores on the TMW-NI knowledge will be compared to pre-intervention scores.

  About 24 hours post intervention

• Change in TMW-NI knowledge survey

  Scores on the TMW-NI knowledge will be compared to pre-intervention scores.

  About 4 weeks post intervention

Secondary Outcomes (1)

• Loss to follow-up

  About 4 weeks post intervention

Study Arms (2)

Treatment intervention

EXPERIMENTAL

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

Control intervention

ACTIVE COMPARATOR

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

Interventions

TMW-Newborn Intervention video OTHER

This is an educational video intervention developed by the Thirty Million Words® Initiative Lab.

Treatment intervention

Safe Sleep for your Baby (SIDS) educational video OTHER

It is an educational video developed by the National Institute of Child Health and Development (NICHD) promoting the prevention of Sudden Infant Death Syndrome.

Control intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postpartum mothers admitted to the mother-baby unit.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Chicago: lead
• National Opinion Research Center: collaborator
• Northwestern University: collaborator

Study Sites (2)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

The University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• 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.

  PMID: 34000494 DERIVED

MeSH Terms

Conditions

Behavior; Communication; Language; Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dana Suskind, MD

  The University of Chicago Medicine

  PRINCIPAL INVESTIGATOR

• Kristin Leffel, AB

  The University of Chicago Medicine

  STUDY CHAIR

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: September 11, 2014
• First Posted: October 17, 2014
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 6, 2017

Record last verified: 2017-12

Locations

US (2)