Randomized Trial of LENA Home in A Home Visiting Program

NCT04031326 | Completed

• 1 other identifier: 2018-8501
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Parent-Child Relations; Language Development

Keywords

home visiting; LENA; infant language development; parenting

Outcome Measures

Primary Outcomes (3)

• Change in Absolute Word Count

  The LENA Home recording device measures Absolute Word Count (AWC) over an approximately 13-hour recording period at each recording. This outcome will involve change in AWC between baseline and a Midpoint assessment (approximately 6-7 weeks) and Endpoint (13-weeks).

  Baseline, Midpoint (6-7 week visit), Endpoint (13 weeks)

• Change in Conversational Turns Count

  The LENA Home recording device measures Conversational Turns Count (CTC) over an approximately 13-hour recording period at each recording. This outcome will involve change in CTC between baseline and a Midpoint assessment (approximately 6-7 weeks) and Endpoint (13-weeks).

  Baseline, Midpoint (6-7 week visit), Endpoint (13 weeks)

• Change in LENA Snapshot Language Assessment Score

  The LENA Developmental Snapshot is a questionnaire that provides parents with an

  Baseline, Midpoint (6-7 week visit), Endpoint (13 weeks)

Secondary Outcomes (4)

• Change in DialogPR-I/T (shared reading quality) Score

  Baseline and Endpoint (13 weeks).

• Change in ScreenQ-I/T (screen-based media use)

  Difference in score between Baseline and Endpoint (13 weeks)

• Change in StimQ-I (home cognitive environment)

  Baseline and Endpoint (13 weeks)

• Change in SPEAK (parenting mindset) score

  Baseline and Endpoint (13 weeks)

Study Arms (2)

LENA Home

EXPERIMENTAL

Home visitors assigned to the intervention group will be trained to use and administer LENA Home in addition to the standard ECS curriculum during designated home visits beginning when the child is between 6- and 9-months old.

Behavioral: LENA Home

Standard Practice

NO INTERVENTION

Home visitors assigned to the control group will administer the standard ECS curriculum only

Interventions

LENA Home BEHAVIORAL

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.

LENA Home

Eligibility Criteria

• Age: 6 Months - 9 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Not meeting the above criteria.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Every Child Succeeds: collaborator
• The Carol Ann and Ralph V. Haile, Jr./U.S. Bank Foundation: collaborator
• Bethesda, Inc.: collaborator

Study Sites (1)

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (3)

• 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.

  PMID: 29388114 BACKGROUND

• 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.

  PMID: 17545382 BACKGROUND

• 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.

  PMID: 30201624 BACKGROUND

Related Links

• Related Info
• Related Info

Study Officials

• John Hutton, MD MS

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-blind randomized trial with 2 groups.

Study Record Dates

• First Submitted: February 16, 2019
• First Posted: July 24, 2019
• Study Start: April 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: August 9, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)