Parent-Child RelationsNCT04031326
Randomized Trial of LENA Home in A Home Visiting Program
A study testing LENA Home in people with Parent-Child Relations and Language Development, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 9 months
- Conditions the study is for
- Parent-Child Relations, Language Development
- What is being tested?
- LENA Home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Not meeting the above criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Feasibility and Effectiveness of LENA Home in the Every Child Succeeds 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.
Read the 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).
- Conditions
- Parent-Child Relations, Language Development
- Being tested
- LENA Home
- Keywords
- home visiting, LENA, infant language development, parenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LENA HomeBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: LENA Home |
| Standard Practice | No intervention | Home visitors assigned to the control group will administer the standard ECS curriculum only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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
Measured: Baseline, Midpoint (6-7 week visit), Endpoint (13 weeks)
Secondary outcomes (4)
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.
Measured: Baseline and Endpoint (13 weeks).
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.
Measured: Difference in score between Baseline and Endpoint (13 weeks)
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.
Measured: Baseline and Endpoint (13 weeks)
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.
Measured: Baseline and Endpoint (13 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start1 Apr 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-blind randomized trial with 2 groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Every Child Succeeds, The Carol Ann and Ralph V. Haile, Jr./U.S. Bank Foundation, Bethesda, Inc.
- Responsible party
- Sponsor
- Investigators
- John Hutton, MD MS, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031326
- Sponsor's protocol ID
- 2018-8501
- Status last verified
- Jun 2020
- First submitted
- 16 Feb 2019
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 29388114Donovan 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.
PubMed 17545382Gilkerson 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.
PubMed 30201624
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of LENA Home in the Every Child Succeeds Home Visiting Program
- ClinicalTrials.gov ID
- NCT04031326
- Acronym / sponsor ID
- 2018-8501
- Conditions
- Parent-Child Relations, Language Development
- Keywords
- home visiting, LENA, infant language development, parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Every Child Succeeds, The Carol Ann and Ralph V. Haile, Jr./U.S. Bank Foundation, Bethesda, Inc.
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 24 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a single-blind randomized trial with 2 groups.
| Arm | Type | Receives |
|---|---|---|
| LENA Home | Experimental | Behavioral: LENA HomeHome 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. |
| Standard Practice | No intervention | –Home visitors assigned to the control group will administer the standard ECS curriculum only |
Who may qualify
- Ages
- 6 to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (1 listed)
- Not meeting the above criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LENA HomeLENA 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. | Behavioural | LENA Home |
Primary outcome
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
4 secondary outcomes
Change in DialogPR-I/T (shared reading quality) Score
Time frame: Baseline and Endpoint (13 weeks).
Change in ScreenQ-I/T (screen-based media use)
Time frame: Difference in score between Baseline and Endpoint (13 weeks)
Change in StimQ-I (home cognitive environment)
Time frame: Baseline and Endpoint (13 weeks)
Change in SPEAK (parenting mindset) score
Time frame: Baseline and Endpoint (13 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Background: PubMed 29388114Bowers 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.
- Background: PubMed 17545382Donovan 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.
- Background: PubMed 30201624Gilkerson 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Hutton, MD MS principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LENA Home in people with Parent-Child Relations and Language Development, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Absolute Word Count (time frame: Baseline, Midpoint (6-7 week visit), Endpoint (13 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04031326, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.