The Relationship Between Child Language Proficiency and Language of Treatment on the Outcomes of Bilingual Children with Developmental Language Disorder

January 12, 2025 updated by: University of Houston
Of the 12 million children in the USA growing up bilingual, about 1 million experience Developmental Language Disorder (DLD), a disorder in language learning and use. Currently there is no guidance for speech language pathologists (SLPs) as to the language of intervention for bilingual children with DLD with differing degrees of proficiency with English or Spanish. This project will examine the relationship between relative language proficiency and the language of intervention, considering monolingual intervention in English and Spanish and bilingual intervention presented by alternating English and Spanish treatment sessions with the goal of improving language outcomes and thereby strengthening long-term academic achievement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

More than 8.5 million children in the USA speak Spanish at home with about a half million experiencing Developmental Language Disorder (DLD), a disorder in language learning and use that cannot be attributed to limited language exposure, autism, intellectual disability, hearing impairment, etc. One key challenge in serving bilingual children with DLD is the mismatch between the language(s) they speak and the availability of Speech Language Pathologists (SLPs) who can provide services in those languages. While it seems self-evident that a monolingual child should be treated in their first language, currently there is no guidance for SLPs as to the language of intervention for bilingual children. Hence, a critical question is what language(s) of treatment will best serve children with DLD with different proficiency profiles in their development of both Spanish and English. The first question is whether gains in the treated language(s) are influenced by the child's proficiency in each language (Aim 1). Cross-linguistic transfer has been documented in priming studies suggesting that underlying syntax representations are interconnected. Transfer effects may make it possible for a child to improve in both languages as a result of treatment in one language, provided that the child has adequate levels of knowledge to connect the information provided in treatment across both languages. The clearest evidence of transfer can be derived from assessing gains in the untreated language when treatment is presented monolingually (Aim 2). Our own preliminary data suggest that recast therapy can result in gains in both English and Spanish for children treated in just one language. In this study, the investigators carry out a randomized controlled trial, enrolling 120 children with DLD between the ages of 4 and 6 who score below 40% correct on the use of conditional adverbial clauses (if-then) and Complement clauses (e.g., he wonders who will be there…). Children receive one of three possible treatments (English-only, Spanish-only, bilingual) for one grammatical structure for 9 weeks, and then outcomes are re-assessed for both structures in both languages. The second grammatical structure is then treated for 9 weeks, and outcomes are assessed a third time. Comparison of different treatment approaches will inform our understanding of what is the best approach to therapy for bilingual children with a particular proficiency profile. Comparison of gains across languages and targets will allow us to determine the role of cross-linguistic transfer in language learning and to inform theoretical accounts of language representation in the developing bilingual child.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Paula Nino Kher

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77204
        • Recruiting
        • School Districst

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. parent concerns and/or a history of receiving services in the public schools
  2. age-specific cutoffs for the morphosyntax subtests for their best language (English or Spanish) on the Bilingual English Spanish Assessment. The cut-off score for best language for 4-year-olds is 84, for 5-year-olds is 85, and for 6-year-olds is 81. Using the best-language approach, these scores have a sensitivity over 90% and specificity over 80% for children between 4;0 and 6;11 years of age , which is considered acceptable for studies of diagnostic accuracy.
  3. nonverbal IQ, as measured by the Kaufman Brief Intelligence Test-2, matrices subtest, will be at or above a standard score of 70.
  4. pass a hearing screening test
  5. participants must be bilingual, that is children must be producing at least simple sentences in spontaneous speech in both Spanish and English, or understand English and Spanish.
  6. participants must be able to benefit from treatment for both conditional adverbial clauses and complement clauses, as evidenced by accuracy below 40% on 10-item elicited production probes in both languages

Exclusion Criteria:

  • 1) children with significant sensory-motor concerns or psychiatric disorders per parent report will not be enrolled.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: sentence recast in Spanish only
A trained, bilingual SLP will treat the targeted structure at a rate of ~ 1 recast per minute, for 16 hours spread over 9 weeks to obtain a planned dose of 912-1008 recasts (960 +/- 5%). Following evidence on enhanced conversational recasting, the SLP will obtain the child's attention before recasting and systematically vary the lexical items in the recasts. Children receiving monolingual Spanish therapy will have the entire treatment session conducted in Spanish.
Behavioral: Sentence recast
Recast therapy is a well-established treatment for grammar in children with DLD. In this treatment, the adult repeats the child's own utterance, altering it to include the taught structure. It yields consistent large effect sizes (Hedge's g = 0.7-1.0) when focused on a single target and provided at a high dose (10-20 hrs. of therapy at a rate of ~1 recast/minute or ~600-1000 recasts total) for both morphology and syntax .
Experimental: sentence recast in English only
A trained, bilingual SLP will treat the targeted structure at a rate of ~ 1 recast per minute, for 16 hours spread over 9 weeks to obtain a planned dose of 912-1008 recasts (960 +/- 5%). Following evidence on enhanced conversational recasting , the SLP will obtain the child's attention before recasting and systematically vary the lexical items in the recasts. Children receiving monolingual English therapy will have the entire treatment session conducted in English.
Behavioral: Sentence recast
Recast therapy is a well-established treatment for grammar in children with DLD. In this treatment, the adult repeats the child's own utterance, altering it to include the taught structure. It yields consistent large effect sizes (Hedge's g = 0.7-1.0) when focused on a single target and provided at a high dose (10-20 hrs. of therapy at a rate of ~1 recast/minute or ~600-1000 recasts total) for both morphology and syntax .
Experimental: sentence recast - Bilingual (Spanish+English) intervention
Treatment will differ from monolingual therapy in that the child will be seen by two SLPs in keeping with one-person one-language models. This allows us to ensure that the dose in each language is controlled and supports the use of both languages evenly in therapy. Sessions will alternate between English-only therapy and Spanish-only therapy - thus the child will receive 8 hours of therapy treating the selected target in English and 8 hours treating the selected target in Spanish. A child in bilingual therapy will receive approximately 456-504 (480 +/- 5%) recasts in each language for a total of 912-1008 recasts combined.
Behavioral: Sentence recast
Recast therapy is a well-established treatment for grammar in children with DLD. In this treatment, the adult repeats the child's own utterance, altering it to include the taught structure. It yields consistent large effect sizes (Hedge's g = 0.7-1.0) when focused on a single target and provided at a high dose (10-20 hrs. of therapy at a rate of ~1 recast/minute or ~600-1000 recasts total) for both morphology and syntax .

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Accuracy on elicited production probes (conditional or nominal)
Time Frame: ~1 month before (Pre), 2 weeks before second structure (Mid) and 2 weeks after treatment (Post test)
Accuracy on elicited production probes are the primary outcome measure. There are 40 probes in total. Ten for Spanish conditionals, ten English conditionals, ten Spanish complement clauses and ten English complement clauses.
~1 month before (Pre), 2 weeks before second structure (Mid) and 2 weeks after treatment (Post test)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of target structure (conditional or nominal) produced during a story retell task
Time Frame: ~1 month before (Pre), 2 weeks before second structure (Mid) and 2 weeks after treatment (Post test)
Language samples serve as a means to assess functional change. Narratives are more likely than conversation to elicit complex syntactic forms while still being appropriate for this age range. Children will provide one story retell in each language before, at midpoint, and after treatment. Frog books from Mercer Meyer with story-retell scripts developed for this study will be used. The investigators will obtain the number of target utterances used in each language.
~1 month before (Pre), 2 weeks before second structure (Mid) and 2 weeks after treatment (Post test)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Houston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Deafness and Other Communication Disorders (NIDCD)
University of Delaware

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 8, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00002073 (University of Houston)
  • R01DC020183 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

General summary data and individual-level data will be shared for the following variables: Age, parent education level, scores on standardized tests associated with eligibility and relative language proficiency, percent correct on pre-/mid-/post-test elicited production probes, and summary variables for language sample data (e.g., number of target utterances). This information will be made available in the form of a comma delimited text file and a code book. Individuals' identities by redacting birthdates and date of examination from the available records will be disguised by replacing names with coded alphanumeric values. Materials (books, probes, training tips, training videos, etc.) will be available to SLPs and other researchers upon request. Audio files cannot be fully deidentified; therefore, data at the child level will only be available with IRB approval.

IPD Sharing Time Frame

One year after final data collection

IPD Sharing Access Criteria

IRB approval for access to some data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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