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Completed

NCT Number: NCT04031326

Randomized Trial of LENA Home in A Home Visiting Program

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.

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Key information

Conditions

Parent-Child Relations Language Development

Age range

6 month–9 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

Not meeting the above criteria.

Treatment and study plan

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.

Primary outcomes

  1. Change in Absolute Word Count

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

    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).

  2. Change in Conversational Turns Count

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

    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).

  3. Change in LENA Snapshot Language Assessment Score

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

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

Secondary outcomes

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

    Time frame: Baseline and Endpoint (13 weeks).

    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.

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

    Time frame: Difference in score between Baseline and Endpoint (13 weeks)

    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.

  3. Change in StimQ-I (home cognitive environment)

    Time frame: Baseline and Endpoint (13 weeks)

    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.

  4. Change in SPEAK (parenting mindset) score

    Time frame: Baseline and Endpoint (13 weeks)

    The SPEAK assessment is an assessment of parental mindset towards their infant's development. Higher score suggests more empowered parental mindset.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Bethesda, Inc.
  • Every Child Succeeds
  • The Carol Ann and Ralph V. Haile, Jr./U.S. Bank Foundation

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 24, 2019
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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