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Language DevelopmentNCT04905381

Can the Language Environment Analysis Start Program Improve Children's Readiness for School? LENA Program Evaluation

A study testing LENA Star Program sessions in people with Language Development, run by William Marsh Rice University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The objective of the project is to implement the LENA Start Program at the Alief The objective of the project is to implement the LENA Start Program at the Alief Independent School District in Houston, Texas. Read more about this study

Who is it for?
Ages 16 to 30 monthsHealthy volunteers can take part
Conditions the study is for
Language Development
What is being tested?
LENA Star Program sessions
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteUnited States
Study dates
1 Aug 2022to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 16 to 30 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Eligible adult participants include parents who meet all the criteria listed below.
  • Must be 18 years old or older.
  • Must have a child between 16 and 30 months old as of September 1, 2022.
  • Must speak English or Spanish as their native language.
  • Must live in the catchment area of Alief Independent School District. Children of the adult participants enrolled in the study are eligible to participate. The children must meet all the criteria below.
  • 1. Must be between 16 and 30 months old as of September 1, 2022 2. Must speak English or Spanish as their native language. 3. Must live in the catchment area of Alief Independent School District.

Who cannot join

  • Adult participants will not be eligible for this study if they:
  • Are NOT 18 years old or older.
  • Do NOT have a child between 16 and 30 months as of September 1, 2022.
  • Do NOT speak English or Spanish as their native language.
  • Do NOT live in the catchment area of Alief Independent School District.
  • Children will not be eligible for this study if they:
Show all 9Show fewer
  • Are NOT between 16 and 30 months as of September 1, 2022.
  • Do NOT speak English or Spanish as their native language.
  • Do NOT live in the catchment area of Alief Independent School District.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Snejana Nihtianova, PhD contact

713-348-2458 ext. 2458

sn46@rice.edu

Flavio Cunha, PhD contact

713-348-3312 ext. 3312

fc15@rice.edu

United States1 site, 1 recruiting
  • Alief ISD

    Houston, Texas, 77072

    Laura Escamilla

    Recruiting

Other trials in United States

About this study

Official title: Can a Scalable Parenting Program Improve Children's Readiness for School? An Evaluation of the LENA Start Program

The objective of the project is to implement the LENA Start Program at the Alief The objective of the project is to implement the LENA Start Program at the Alief Independent School District in Houston, Texas. The purpose of the study is to learn how maternal expectations about language development influence the child's language development. Also, the study will evaluate how much the mothers believe can affect their child's language development. More specifically, the program implementation will serve as a model that other school districts can readily replicate.

Read the detailed description

The procedures for this study are broken down into four sections. First, we explain how the LENA Start program lottery will randomly assign participants to the control or treatment group. Next, we explain the LENA Start program that the randomly selected study participants will attend. Then, we explain how the LENA system will be used to measure the child's language environment. Finally, we explain the two meetings parents will attend before and after participation in the LENA Start program as part of the evaluation study, including the instruments used for baseline and endline data collection at these meetings.

  1. LENA Start program lottery: Participants who consent to participate in the LENA Start program lottery will be randomly assigned to either the control group or the treatment group. Only the treatment group will complete the LENA Start program. The control group will complete only the pre-program and post-program surveys.
  2. LENA Start Program: If a participant joins the study, they will be invited to participate in the LENA Start Program conditionally upon being randomly assigned to the treatment group. In this program, they will meet other parents who have children of the same age, and they will have the chance to learn and discuss important information about their child's language development. The participants will practice tips about how they can put this information into practice with their own child, thereby enhancing their baby's language development and helping him or her be pre-K ready. Each session will last approximately one hour and there will be ten sessions (one per week). Participants will have the chance to choose a time that best suits their schedule and, if they miss a session, they can always arrange a make-up session with the coordinator. The sessions will take place either online through weekly Zoom meetings with the Alief ISD family liaisons or in person at the Alief ISD intermediate campus family centers. After each session, participants will be asked to have their child use the LENA recorder for a day. Once the recording is finished, we will arrange for the participant to turn in the recorder to one of the research assistants on the team. If the sessions are conducted virtually, the parent will be expected to do a contactless exchange by leaving the LENA recorder at a designated location and picking up a new one. If the sessions are in person, the parent will be expected to bring the LENA device to the session each week. From the LENA device recording, we will produce a report that describes the child's language development as well as the quality of the language environment each child is exposed to (as described above). In the Group Sessions, we will teach participants how to read the information from the report and how they can act in simple ways to greatly improve their child's language environment and, in consequence, his or her language development. Complete Developmental Snapshot: About once a month, we will ask participants to complete the Developmental Snapshot Form. This is a parent-completed evaluation of language skills for infants and toddlers focusing on well-established milestones associated with expressive and receptive language skills. It provides developmental age and percentile ranking information compared to age-matched peers
  3. LENA Recordings: We measure the quality of the language environment at home by using the LENA System. LENA is an integrated processing and cloud-based software package that enables researchers to collect, manage and analyze multiple recordings of children ages 2 months to 48 months. Each parent will be asked to create 14 LENA recordings, two after the pre-program visit, one after each LENA start session, and two after the post-program visit. The research team will download the audio file to the study team computer and transfer to a cloud-based software installed at a server that belongs to the LENA Foundation. The audio file will be processed by the software at the LENA server and will return to the research team four pieces of information: Adult Word Count: The Adult Word Count is the number of words a child hears from an adult within a specific period of time: 5 minutes, hourly, daily. Child Vocalization Count: A child vocalization is counted when a child's speech of any length is surrounded by greater than 300 milliseconds of silence or other sounds which is not child speech. Conversational Turn (CT) Count: A Conversational Turn occurs when a child vocalizes (initiates) and an adult respond, or an adult speaks (initiates) and a child responds. Each time that happens, one turn is counted. Automatic Vocalization Assessment: AVA is an automatic assessment, based on the Adult Word Count, the Child Vocalization Count, and on the Conversational Turn Count. AVA measures a child's expressive language, provides an Estimated Mean Length of Utterance, and estimates the child's language development age. our-by-hour raw counts and age-standardized counts of each one of these five measures of a child's language environment. Once these variables are constructed, the research team will then delete the audio file to prevent any unauthorized use of this file and to reduce the chance of breaches of confidentiality.
  4. Evaluation Study:

An interviewer from the Rice research team will meet with the participants before and after their participation in the LENA Start program to conduct baseline and endline data collection. These meetings will be conducted either in person at one of the Alief ISD intermediate schools or virtually through phone calls or Zoom video meetings, depending on the implementation plan decided upon by the school district.

Baseline data collection (visit 1):

At the pre-program baseline visit, parents will be asked to complete the surveys listed below and will be asked to take their first recordings using the LENA device.

Survey questionnaires:

Parent Questionnaire: The parent questionnaire will ask questions about the child's time use to assess the quantity of interaction between adults and the children. We will elicit parental beliefs about the importance of language environment for language development and parental self-efficacy.

Language Development Snapshot (LDS): The snapshot provides parents an estimate of their child's developmental age concerning expressive and receptive language skills. LDS total scores and age estimates are highly correlated with standardized observation-based and parent report language and cognitive assessments, an indication of instrument validity StimQ: We will use the StimQ instrument to measure the child's environment. The StimQ is a 39 point scale for measuring cognitive stimulation in the homes of children ages 12 to 36 months. It is based on a questionnaire that is administered to the child's primary caregiver by trained interviewers in an office setting. StimQ measures only the role of the child's primary caregiver in providing cognitive stimulation for the child. The fact that the StimQ does not require a home observation is an important advantage over other instruments as home visitation would not be practical in this context. Another advantage of the StimQ instrument is that it is rich in collecting information about materials and activities related to parent-child language interaction. The StimQ contains four sections. The first section is the Availability of Learning Materials (ALM) Scale, which consists of a list of toys and games appropriate for children between 12 and 36 months old. The scale is further divided into toys and materials that can be used for symbolic play (e.g., doll or action figure, puppets, housekeeping toys, etc.), for art (e.g., crayons), for fine motor skills (e.g., shape-sorter toys, stacking toys, etc), for language (e.g., set of toy letters), or life-size toys/materials (e.g., tricycle). The second section is the Reading Scale. This scale asks if parents ever read books to the child, the names of the children's books the parents read in the near past, the frequency parents read to the child, and the types of books parents read to the child (books that teach shapes, or letters, or activities, etc.). The third section measures Parental Involvement in the Developmental Advance and contains ten items about teaching to the child. The fourth section measures Parental Verbal Responsivity, and it asks about the nature of parent language interaction with the child.

MacArthur Bates CDI: We will use the MacArthur-Bates Communicative Development Inventories (MB-CDIs) to capture important information about children's developing abilities in early language. The Words \& Sentences version is are appropriate for children 16-30 months. It contains a 100-word productive vocabulary checklist and a question about combining words.

Complete two 16-hour recording sessions:

At the pre-program meeting, the research assistant will explain to the parent how to use the LENA recorder and answer any questions the parents may have about it. The parent will also receive a package of materials for conducting the first recording.

If the visit is conducted online, the research assistant will ask the parent how they would like to receive the recording materials package. The parent will be able to choose among the following methods for receiving their recording materials package: a) mail, b) contactless delivery by courier (member of the Rice research team will drop off the package on the family's doorstep) or c) contactless pickup from a designated Alief ISD intermediate school. The parent will also be asked to specify how they would like to return the LENA recording package, either a) mail, b) contactless pickup by courier or c) contactless drop-off at a designated Alief ISD intermediate school.

Endline data collection (visit 2):

At the post-program visit, participants will be asked to complete the same questionnaires as at the pre-program visit (the Parent Survey, the Language Development Snapshot, the StimQ) except MacArthur Bates. The participants will also be asked to complete another two 16-hour recordings using the LENA device. The same options for receiving and returning the LENA recording device will be offered to parents and they will be asked to choose their preferred method.

Fidelity of implementation data collection:

At each of the 10 LENA program sessions, a member of the Rice research team will attend (either virtually or in-person) and collect data about Fidelity of Implementation of the LENA program, including liaison adherence to the material in the session, parental behavior at the session, liaison workload and preparation, as well as other measures of fidelity.

Additionally, at the beginning of every session, a Rice research team member will administer a questionnaire to the liaisons as part of the Fidelity of Implementation data collection.

This data will be collected in both the in-person implementation plan or the virtual implementation plan. If sessions are conducted virtually, a member of the Rice research team will join the weekly Zoom meeting. If sessions are conducted in person, the research team member will attend the weekly meetings in Alief schools.

Being tested
Usual care, LENA Star Program sessions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Usual careBehavioural

    This arm receives usual care (control group)

  • LENA Star Program sessionsBehavioural

    LENA Start is an evidence-based community program designed to engage families and help them learn how to increase conversation with their children during the first few years of life.

Study groups in NCT04905381
Study groupRoleWhat they receive
Usual careActive comparatorBehavioral: This arm receives usual care (control group). This group will attend their usual Alief group sessions.
Receives: Behavioral: Usual care
LENA Star programExperimentalBehavioral:LENA Star program. Participants who are selected via the lottery to participate in the LENA Star program will complete ten weekly, 1-hour sessions.
Receives: Behavioral: LENA Star Program sessions

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of the Language Environment: Language Environment Analysis (LENA System)

    The quality of the language environment at home will be measured by using the LENA System. LENA is an integrated processing and cloud-based software package that enables researchers to collect, manage, and analyze multiple recordings of children ages 2 months to 48 months.LENA device estimates adult words spoken to and around the key child, adult-child conversational interactions, child vocalizations, and language from Television and/or electronics

    Measured: Measured at 16 to 30 months of age

  2. Measurement of the Child's Home Environment

    StimQ Availability of Learning Materials Scale (ALM). The availability of learning materials will be measured by using the StimQ ALM scale. The StimQ is a structured interview. Individual items are summed, and scores range ranges from 0 to 7. Higher scores are correlated with better parental behavior.

    Measured: Measured at 16 to 30 months of age

  3. Measurement of the Child's Home Environment

    StimQ READ Scale: Reading activity will be measured by using the StimQ Reading Scale. The StimQ is a structured interview. Individual items are summed, and scores range ranges from 0 to 19. Higher scores reflect higher reading activities.

    Measured: Measured at 16 to 30 months of age

  4. Measurement of the Child's Home Environment

    StimQ Parental Involvement in the Developmental Advance scale (PIDA). The prenatal involvement in child development will be measured by using the StimQ PIDA scale. The StimQ is a structured interview. Individual items are summed, and scores range ranges from 0 to 10. Higher scores reflect higher parent involvement.

    Measured: Measured at 16 to 30 months of age

  5. Measurement of the Child's Home Environment

    StimQ Parental Verbal Responsivity Scale (PVR). Parent verbal responsiveness will be measured using the StimQ Parental Verbal Responsivity Scale. The StimQ is a structured interview. Individual items are summed, and scores range ranges from 0 to 4. Higher scores reflect higher parent verbal responsiveness.

    Measured: Measured at 16 to 30 months of age

  6. Parent beliefs questionnaire

    Adult-child interaction quality assessment. The questioner elicits parental beliefs about the importance of language environment for language development and parental self-efficacy.

    Measured: Measured at 16 to 30 months of age

  7. Language Development Snapshot (LDS) report

    The Language Developmental Snapshot is a parent report that provides an estimate of child's developmental age with respect to receptive and expressive language skills.

    Measured: Measured at 16 to 30 months of age

  8. Fidelity of implementation

    At each of the 10 LENA program sessions, a member of the Rice research team will attend (either virtually or in person) and collect data about Fidelity of Implementation of the LENA program, including liaison adherence to the material in the session, parental behavior at the session, liaison workload and preparation, as well as other measures of fidelity.

    Measured: Through study completion, an average of 1 year

  9. MacArthur Bates Communicative Development Inventories (CDI)

    Parent questionnaire of receptive and expressive language skills. The inventory will be used to capture important information about children's developing abilities in early language. The Words and Sentences version is are appropriate for children 16-30 months. It contains a 100-word productive vocabulary checklist and a question about combining words. Standard scores are based on percentiles for age and sex and range from <1 to 99th percentile. Raw scores range from 0 to 680. Both higher standard scores and raw scores indicate better performance.

    Measured: Measured at 16 to 30 months of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2021
  2. Study start1 Aug 2022
  3. Primary completion30 Oct 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04905381
Sponsor's protocol ID
2020-8
Status last verified
Apr 2026
First submitted
5 Aug 2020
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing LENA Star Program sessions in people with Language Development, run by William Marsh Rice University 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 9 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: looking for participants now, as of the sponsor's last update on 24 Apr 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Snejana Nihtianova, PhD (713-348-2458 ext. 2458, sn46@rice.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of the Language Environment: Language Environment Analysis (LENA System) (time frame: Measured at 16 to 30 months of age). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 24 Apr 2026.

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