Pilot Study of Novel Postpartum Educational Video Intervention

NCT ID: NCT02267265

Last Updated: 2017-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 694 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

TMW-Newborn Intervention video

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Safe Sleep for your Baby (SIDS) educational video

Intervention Type: 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.

Interventions

TMW-Newborn Intervention video

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

Intervention Type: 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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Opinion Research Center

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dana Suskind, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Chicago Medicine

Kristin Leffel, AB

Role: STUDY_CHAIR

The University of Chicago Medicine

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

The University of Chicago Medicine

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34000494 (View on PubMed)

Other Identifiers

TMW-NI

Identifier Type: -

Identifier Source: org_study_id