Clinical trial NCT04031326: Randomized Trial of LENA Home in A Home Visiting Program
Official title: Feasibility and Effectiveness of LENA Home in the Every Child Succeeds Home Visiting Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parent-Child Relations
Language Development
Keywords: home visiting
LENA
infant language development
parenting
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Every Child Succeeds
name: The Carol Ann and Ralph V. Haile, Jr./U.S. Bank Foundation
name: Bethesda, Inc.
First posted: 2019-07-24
Enrollment: 31
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-blind randomized trial with 2 groups.
Primary purpose: PREVENTION

Brief summary: This study evaluates feasibility and efficacy of adding the LENA Home program to the standard Every Child Succeeds (ECS) home visiting curriculum. Half of the participants will receive the standard ECS curriculum during normally scheduled home visits, while the other half will receive this plus LENA Home.

Detailed description: Every Child Succeeds is a program that uses home visiting as a preventive strategy to support low income families in providing stimulating, safe, and nurturing environments for their young children. Most families in home visiting have experienced adversity in their lives, and had inadequate parenting role models as they grew up. Home visitors visit families during pregnancy through the child reaching three years of age, providing information, teaching, and resources to help parents provide the best possible start for their children.

LENA Home is a 13-week curriculum designed to add an early-language focus to existing home visiting or parent education programs for children ages birth to three. It employs LENA wearable audio recorder technology and targeted content to help parents and other caregivers increase interactive talk. There are 13 weekly one-on-one sessions, including modules on parent-child reading and increasing verbal interaction during typical home activities. Sessions include videos, practical techniques, and feedback from LENA recordings via intuitive reports to help parents talk more with their children. LENA Home reports provide data on adult words spoken to the child (AWC) and conversational turns (CTC). LENA Home has been shown to increase interactive talk and child language ability and informs parents how much they are talking with their children in an objective way.

Upon completion of the study, we will have more information regarding whether (1) LENA Home can be successfully integrated into existing home visiting programs (feasibility), (2) children exposed to LENA have larger vocabularies than those who do not receive the intervention, (3) mothers using LENA engage in more literacy-promoting behaviors relative to controls, and (4) LENA improves parent-child interactions (utility).

Eligibility criteria: Inclusion Criteria:

1. enrollment in the Every Child Succeeds home visiting program,
2. child age between 6- and 9-months old,
3. English-speaking household,
4. child gestation of at least 32 weeks,
5. child has no known neurobehavioral/genetic syndrome or brain injury likely to cause language delay,
6. maternal age at least 15 years old.

Exclusion Criteria:

Not meeting the above criteria.

Primary outcomes:
measure: Change in Absolute Word Count
timeFrame: Baseline, Midpoint (6-7 week visit), Endpoint (13 weeks)
measure: Change in Conversational Turns Count
timeFrame: Baseline, Midpoint (6-7 week visit), Endpoint (13 weeks)
measure: Change in LENA Snapshot Language Assessment Score
timeFrame: Baseline, Midpoint (6-7 week visit), Endpoint (13 weeks)
Secondary outcomes:
measure: Change in DialogPR-I/T (shared reading quality) Score
timeFrame: Baseline and Endpoint (13 weeks).
measure: Change in ScreenQ-I/T (screen-based media use)
timeFrame: Difference in score between Baseline and Endpoint (13 weeks)
measure: Change in StimQ-I (home cognitive environment)
timeFrame: Baseline and Endpoint (13 weeks)
measure: Change in SPEAK (parenting mindset) score
timeFrame: Baseline and Endpoint (13 weeks)
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
Study officials:
affiliation: Assistant Professor
name: John Hutton, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bowers K, Folger AT, Zhang N, Sa T, Ehrhardt J, Meinzen-Derr J, Goyal NK, Van Ginkel JB, Ammerman RT. Participation in Home Visitation is Associated with Higher Utilization of Early Intervention. Matern Child Health J. 2018 Apr;22(4):494-500. doi: 10.1007/s10995-017-2415-8.
citation: Donovan EF, Ammerman RT, Besl J, Atherton H, Khoury JC, Altaye M, Putnam FW, Van Ginkel JB. Intensive home visiting is associated with decreased risk of infant death. Pediatrics. 2007 Jun;119(6):1145-51. doi: 10.1542/peds.2006-2411.
citation: Gilkerson J, Richards JA, Warren SF, Oller DK, Russo R, Vohr B. Language Experience in the Second Year of Life and Language Outcomes in Late Childhood. Pediatrics. 2018 Oct;142(4):e20174276. doi: 10.1542/peds.2017-4276. Epub 2018 Sep 10.