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Trial record 2 of 2 for:    every child

Randomized Trial of LENA Home in A Home Visiting Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04031326
Recruitment Status : Completed
First Posted : July 24, 2019
Last Update Posted : June 16, 2020
Sponsor:
Collaborators:
Every Child Succeeds
The Carol Ann and Ralph V. Haile, Jr./U.S. Bank Foundation
Bethesda, Inc.
Information provided by (Responsible Party):
John Hutton, MD FAAP, Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date  ICMJE February 16, 2019
First Posted Date  ICMJE July 24, 2019
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE April 1, 2019
Actual Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • 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).
  • 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).
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Trial of LENA Home in A Home Visiting Program
Official Title  ICMJE Feasibility and Effectiveness of LENA Home in the Every Child Succeeds Home Visiting Program
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a single-blind randomized trial with 2 groups.
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Parent-Child Relations
  • Language Development
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: LENA Home
  • No Intervention: Standard Practice
    Home visitors assigned to the control group will administer the standard ECS curriculum only
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2020)
31
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2019)
35
Actual Study Completion Date  ICMJE February 1, 2020
Actual Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 9 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04031326
Other Study ID Numbers  ICMJE 2018-8501
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Access to data will be restricted to protect the privacy of enrolled subjects. It may be made available in a de-identified fashion in the future.
Responsible Party John Hutton, MD FAAP, Children's Hospital Medical Center, Cincinnati
Study Sponsor  ICMJE Children's Hospital Medical Center, Cincinnati
Collaborators  ICMJE
  • Every Child Succeeds
  • The Carol Ann and Ralph V. Haile, Jr./U.S. Bank Foundation
  • Bethesda, Inc.
Investigators  ICMJE Not Provided
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP