Recruiting

LENA Program

Sponsor:

William Marsh Rice University

Code:

NCT04905381

Conditions

Language Development

Eligibility Criteria

Sex: All

Age: 1 - 2

Healthy Volunteers: Accepted

Interventions

Usual care

LENA Star Program sessions

Study Details

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.

Conditions

Language Development

Study ID

NCT04905381

Start date

Aug 1, 2022

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Oct 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 2

Healthy Volunteers: Accepted

Inclusion Criteria:

Eligible adult participants include parents who meet all the criteria listed below.

1. Must be 18 years old or older.
2. Must have a child between 16 and 30 months old as of September 1, 2022.
3. Must speak English or Spanish as their native language.
4. 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.

Exclusion Criteria:

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.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Usual care

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

experimental: LENA Star program

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.

Interventions

Usual care

This arm receives usual care (control group)

LENA Star Program sessions

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.

Primary outcome measure

  • Quality of the Language Environment: Language Environment Analysis (LENA System) [ Time Frame: Measured at 16 to 30 months of age ]
  • Measurement of the Child's Home Environment [ Time Frame: Measured at 16 to 30 months of age ]
  • Measurement of the Child's Home Environment [ Time Frame: Measured at 16 to 30 months of age ]
  • Measurement of the Child's Home Environment [ Time Frame: Measured at 16 to 30 months of age ]
  • Measurement of the Child's Home Environment [ Time Frame: Measured at 16 to 30 months of age ]
  • Parent beliefs questionnaire [ Time Frame: Measured at 16 to 30 months of age ]
  • Language Development Snapshot (LDS) report [ Time Frame: Measured at 16 to 30 months of age ]
  • Fidelity of implementation [ Time Frame: Through study completion, an average of 1 year ]
  • MacArthur Bates Communicative Development Inventories (CDI) [ Time Frame: Measured at 16 to 30 months of age ]

Central Contacts and Locations

Central contacts

Snejana Nihtianova, PhD

713-348-2458sn46@rice.edu

Flavio Cunha, PhD

713-348-3312fc15@rice.edu

Locations

Alief ISD

Recruiting

Houston, Texas, United States, 77072

More Information

Sponsor

William Marsh Rice University

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by William Marsh Rice University on 2026-04-24.