NCT04905381

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Aug 2022Dec 2028

First Submitted

Initial submission to the registry

August 5, 2020

Completed
10 months until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

6.3 years

First QC Date

August 5, 2020

Last Update Submit

April 21, 2026

Conditions

Outcome Measures

Primary Outcomes (9)

  • 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 at 16 to 30 months of age

  • 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 at 16 to 30 months of age

  • 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 at 16 to 30 months of age

  • 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 at 16 to 30 months of age

  • 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 at 16 to 30 months of age

  • 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 at 16 to 30 months of age

  • 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 at 16 to 30 months of age

  • 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.

    Through study completion, an average of 1 year

  • 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 at 16 to 30 months of age

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Behavioral: This arm receives usual care (control group). This group will attend their usual Alief group sessions.

Behavioral: Usual care

LENA Star program

EXPERIMENTAL

Behavioral:LENA Star program. Participants who are selected via the lottery to participate in the LENA Star program will complete ten weekly, 1-hour sessions.

Behavioral: LENA Star Program sessions

Interventions

Usual careBEHAVIORAL

This arm receives usual care (control group)

Usual care

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.

LENA Star program

Eligibility Criteria

Age16 Months - 30 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • \. 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.

You may not qualify if:

  • 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:
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alief ISD

Houston, Texas, 77072, United States

RECRUITING

Study Officials

  • Snejana Nihtaianova, PhD

    William Marsh Rice University

    STUDY DIRECTOR

Central Study Contacts

Snejana Nihtianova, PhD

CONTACT

Flavio Cunha, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2020

First Posted

May 27, 2021

Study Start

August 1, 2022

Primary Completion (Estimated)

October 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations