Randomized Trial of LENA Home in A Home Visiting Program

NCT ID: NCT04031326

Last Updated: 2021-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parent-Child Relations Language Development

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a single-blind randomized trial with 2 groups.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LENA Home

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.

Group Type EXPERIMENTAL

LENA Home

Intervention Type 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.

Standard Practice

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

9 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Every Child Succeeds

UNKNOWN

Sponsor Role collaborator

The Carol Ann and Ralph V. Haile, Jr./U.S. Bank Foundation

UNKNOWN

Sponsor Role collaborator

Bethesda, Inc.

UNKNOWN

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John Hutton, MD MS

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29388114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17545382 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30201624 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-8501

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Thirty Million Words Home Visiting
NCT02216032 ACTIVE_NOT_RECRUITING NA
Addressing Treatment Nonresponders
NCT05921227 NOT_YET_RECRUITING PHASE2
Efficacy of Let's Know! First Grade
NCT06945289 COMPLETED NA