Randomized Trial of LENA Home in A Home Visiting Program

Parent-Child Relations Clinical Trial

Official title:

Feasibility and Effectiveness of LENA Home in the Every Child Succeeds Home Visiting Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04031326
• Other study ID #: 2018-8501
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: June 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 9 Months

Eligibility

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.

Related Conditions & MeSH terms

• Language Development
• Parent-Child Relations

Intervention

Behavioral:
• LENA Home
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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Medical Center	Cincinnati	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Bethesda, Inc., Every Child Succeeds, The Carol Ann and Ralph V. Haile, Jr./U.S. Bank Foundation

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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). pii: e20174276. doi: 10.1542/peds.2017-4276. Epub 2018 Sep 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Change in DialogPR-I/T (shared reading quality) Score	Dialog PR-I/T is a 10-item measure of shared reading quality (interactivity) for infants and toddlers developed by the PI that is derived from the validated DialogPR measure for older children. It involves evidence-based behaviors such as lap sitting, use of child-directed speech, and verbal responsivity. Range is 0-30, higher score suggests more interactive, nurturing reading.	Baseline and Endpoint (13 weeks).
Secondary	Change in ScreenQ-I/T (screen-based media use)	ScreenQ-I/T is a 10-item composite measure of screen-based media use in the home referenced to current AAP guidelines for infants and toddlers, developed by the PI that is based on the validated ScreenQ measure for older children. Range is 0-23 points, higher scores suggest greater use contrary to AAP guidelines and greater developmental/health risk.	Difference in score between Baseline and Endpoint (13 weeks)
Secondary	Change in StimQ-I (home cognitive environment)	The StimQ-I is a validated assessment of parent report measure of cognitive stimulation in the home for children up to 18-months old involving 4 subscales: availability of learning materials, parental involvement in developmental advance, parental verbal responsivity, and reading. Higher scores suggest more stimulating parental behaviors.	Baseline and Endpoint (13 weeks)
Secondary	Change in SPEAK (parenting mindset) score	The SPEAK assessment is an assessment of parental mindset towards their infant's development. Higher score suggests more empowered parental mindset.	Baseline and Endpoint (13 weeks)

External Links

•   Related Info
•   Related Info