ClinicalTrials.gg
RecruitingNCT06085300Updated Jan 14, 2025

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

An interventional study of Sentence recast in Developmental Language Disorder and Language Impairment, sponsored by University of Houston. Recruiting at 1 site in United States. Open to participants aged 4 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-14.

Sponsored by University of Houston · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
4 Years to 6 Years
Sex
All
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Study summary

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.

Read the 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.

02

Conditions studied

  • Developmental Language Disorder
  • Language Impairment

Keywords

  • developmental language disorder
  • bilingual children
  • sentence recast
  • Bilingual proficiency
  • Language transfer
03

In context

Language Development Disorders

121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.

This study's planned enrollment of 120 is above the median of 74 across 106 interventional studies indexed under Language Development Disorders.

Browse Language Development Disorders studies →

Lead sponsor

University of Houston is the lead sponsor of 102 studies on the registry; 17 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

    1. children with significant sensory-motor concerns or psychiatric disorders per parent report will not be enrolled.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • BehavioralSentence 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 .

06

What researchers measure

Primary outcomes

  1. Accuracy on elicited production probes (conditional or nominal)

    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.

    Time frame: ~1 month before (Pre), 2 weeks before second structure (Mid) and 2 weeks after treatment (Post test)

Secondary outcomes

  1. Number of target structure (conditional or nominal) produced during a story retell task

    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.

    Time frame: ~1 month before (Pre), 2 weeks before second structure (Mid) and 2 weeks after treatment (Post test)

07

Study locations

1 of 1 sites recruiting
  • School Districst
    Houston, Texas 77204, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code

Time frame: One year after final data collection

Access criteria: IRB approval for access to some data.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2023 (actual). Primary completion is estimated for May 2028, 56 months after the start.

Of 72 non-industry interventional studies with no phase under Language Development Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's planned 56 months is above that.

Counting every sponsor, half of 72 studies reached it within 30 months; a quarter within 19 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2023
First posted
Oct 16, 2023
StartActual
Aug 8, 2023
Primary completionEst.
May 1, 2028
CompletionEst.
May 1, 2028
Last update
Jan 14, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06085300
Responsible party
Sponsor
First posted
Oct 16, 2023
Start date
Aug 8, 2023
Primary completion
May 1, 2028 (estimated)
Completion
May 1, 2028 (estimated)
Last update
Jan 14, 2025

Study contacts

Anny Castilla-Earls
Contact
annycastilla@uh.edu
713-743-0488
Paula Nino Kher
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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