Developmental Language DisorderNCT06866223
Emergent Bilinguals: Child Language Proficiency and Language of Treatment
A study testing Sentence recast in people with Developmental Language Disorder and Language Impairment, run by University of Houston at 1 site in United States.
Trial 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 emergent Spanish-English bilingual… Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Language Disorder, Language Impairment
- What is being tested?
- Sentence recast
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2024to 1 Jul 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- parent concerns and/or a history of receiving services in the public schools
- 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.
- nonverbal IQ, as measured by the Kaufman Brief Intelligence Test-2, matrices subtest, will be at or above a standard score of 70.
- pass a hearing screening test
- participants must be emergent bilingual, that is children must be producing at least simple sentences in spontaneous speech in either Spanish or English and be exposed to both langauges
- 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
Who cannot join
- 1) children with significant sensory-motor concerns or psychiatric disorders per parent report will not be enrolled.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Houston
Houston, Texas, 77204
Anny Castilla-Earls, PhD, 713-7430488, annycastilla@uh.edu
About this study
Official title: Emergent Bilinguals: the Relationship Between Child Language Proficiency and Language of Treatment on the Outcomes Children with Developmental Language Disorder
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 emergent Spanish-English bilingual children with DLD. This project will examine the relationship between language proficiency and the language of intervention, considering monolingual intervention (Spanish or English) and interleaved Spanish-English intervention 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 (U.S. Census Table S1601, 2020) with about a half million experiencing Developmental Language Disorder (DLD), a disorder in language learning and use not attributed to limited language exposure, autism, intellectual disability, etc. (Norbury et al., 2016). Bilingual children with DLD experience language-learning difficulties in both languages, including documented difficulty with complex syntax (Gutiérrez-Clellen, 1998; Jasso et al., under review). While it is self-evident that a monolingual child should be treated in their first language, currently there is no guidance for speech-language pathologists as to the language of intervention for bilingual children (Kohnert, et al., 2005). This is exacerbated by the fact that DLD varies in severity and bilingualism exists across a continuum, ranging from nearly monolingual in either language A or B to balanced bilingualism with good fluency in both languages. Furthermore, children who enter school with only limited proficiency in the majority language (e.g., English) rapidly become more proficient. This continuum is exemplified in our data. Recast therapy, an evidence-based intervention for grammatical difficulties (Cleave et al., 2015), is thought to work via mechanisms similar to priming (Leonard, 2011). Critically, cross-linguistic priming in bilingual children depends on proficiency (Vasilyeva et al., 2010) suggesting a need to align recast therapy with the child's proficiency profile (Gutiérrez-Clellen et al., 2012).
- Being tested
- Sentence recast
- Medical subject headings
- Language Development Disorders, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentence recastBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Monolingual therapy | Experimental | 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 the dominant language of the child (Spanish or English). Receives: Behavioral: Sentence recast |
| Interleaved therapy | Experimental | 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 will receive therapy in the dominant language (Spanish or English) and will also be offered the opportunity to use the non-dominant language (Spanish or English) via communication bid in the child's non-dominant language every 3-5 minutes and continue in that language as long as the child responds. If the child does not respond or responds in their dominant language, the examiner will switch to the other language. Receives: Behavioral: Sentence recast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ~1 month before (Pre), 2 weeks before second structure (Mid) and 2 weeks after treatment (Post test)]
Secondary outcomes (1)
Mean Length of Utterance and Subordination Index in English
Calculated from a story retell in English. Mean length of utterance and subordination index.
Measured: ~1 month before (Pre), 2 weeks before second structure (Mid) and 2 weeks after treatment (Post test)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start11 Nov 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Language DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Model description
- Participants will be randomly assigned to one of two conditions: monolingual recast therapy delivered in English or Spanish, and interleaved therpay (bilingual therapy) Schools are randomly assigned to first treatment target (conditional adverbial clause; complement clause). The investigators use a cross-over design such that all children eventually receive treatment for all targets. Pretesting will be completed for both targets in both languages. Children will be stratified based on bilingual proficiency (Spanish-dominant (receptive English or simple sentences in English), English-dominant, Balanced) and randomly assigned to language of intervention. Children will receive 16 hours of recast therapy. After, both structures will be tested in both languages again. Then, treatment target will switch and children will receive an additional 16 hours of treatment for the second structure. At post-test, both structures will be tested in both languages.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of Delaware
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866223
- Sponsor's protocol ID
- 5R01DC020183
- Other IDs
- STUDY00002073
- Status last verified
- Mar 2025
- First submitted
- 4 Mar 2025
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergent Bilinguals: the Relationship Between Child Language Proficiency and Language of Treatment on the Outcomes Children with Developmental Language Disorder
- ClinicalTrials.gov ID
- NCT06866223
- Acronym / sponsor ID
- 5R01DC020183
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of Delaware
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 emergent Spanish-English bilingual children with DLD. This project will examine the relationship between language proficiency and the language of intervention, considering monolingual intervention (Spanish or English) and interleaved Spanish-English intervention with the goal of improving language outcomes and thereby strengthening long-term academic achievement
Detailed description
More than 8.5 million children in the USA speak Spanish at home (U.S. Census Table S1601, 2020) with about a half million experiencing Developmental Language Disorder (DLD), a disorder in language learning and use not attributed to limited language exposure, autism, intellectual disability, etc. (Norbury et al., 2016). Bilingual children with DLD experience language-learning difficulties in both languages, including documented difficulty with complex syntax (Gutiérrez-Clellen, 1998; Jasso et al., under review). While it is self-evident that a monolingual child should be treated in their first language, currently there is no guidance for speech-language pathologists as to the language of intervention for bilingual children (Kohnert, et al., 2005). This is exacerbated by the fact that DLD varies in severity and bilingualism exists across a continuum, ranging from nearly monolingual in either language A or B to balanced bilingualism with good fluency in both languages. Furthermore, children who enter school with only limited proficiency in the majority language (e.g., English) rapidly become more proficient. This continuum is exemplified in our data. Recast therapy, an evidence-based intervention for grammatical difficulties (Cleave et al., 2015), is thought to work via mechanisms similar to priming (Leonard, 2011). Critically, cross-linguistic priming in bilingual children depends on proficiency (Vasilyeva et al., 2010) suggesting a need to align recast therapy with the child's proficiency profile (Gutiérrez-Clellen et al., 2012).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two conditions: monolingual recast therapy delivered in English or Spanish, and interleaved therpay (bilingual therapy) Schools are randomly assigned to first treatment target (conditional adverbial clause; complement clause). The investigators use a cross-over design such that all children eventually receive treatment for all targets. Pretesting will be completed for both targets in both languages. Children will be stratified based on bilingual proficiency (Spanish-dominant (receptive English or simple sentences in English), English-dominant, Balanced) and randomly assigned to language of intervention. Children will receive 16 hours of recast therapy. After, both structures will be tested in both languages again. Then, treatment target will switch and children will receive an additional 16 hours of treatment for the second structure. At post-test, both structures will be tested in both languages.
| Arm | Type | Receives |
|---|---|---|
| Monolingual therapy | Experimental | Behavioral: Sentence recastA 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 the dominant language of the child (Spanish or English). |
| Interleaved therapy | Experimental | Behavioral: Sentence recastA 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 will receive therapy in the dominant language (Spanish or English) and will also be offered the opportunity to use the non-dominant language (Spanish or English) via communication bid in the child's non-dominant language every 3-5 minutes and continue in that language as long as the child responds. If the child does not respond or responds in their dominant language, the examiner will switch to the other language. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- parent concerns and/or a history of receiving services in the public schools
- 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.
- nonverbal IQ, as measured by the Kaufman Brief Intelligence Test-2, matrices subtest, will be at or above a standard score of 70.
- pass a hearing screening test
Key exclusion criteria (1 listed)
- 1) children with significant sensory-motor concerns or psychiatric disorders per parent report will not be enrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentence recastRecast 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 | Behavioural | Interleaved therapy, Monolingual therapy |
Primary outcome
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 secondary outcome
Mean Length of Utterance and Subordination Index in English
Time frame: ~1 month before (Pre), 2 weeks before second structure (Mid) and 2 weeks after treatment (Post test)]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: 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:
Related trials for Developmental Language Disorder
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
Recruiting
Personalization of Visual Characters and Text-to-Speech (TTS) to Support Learning in Students With Reading Difficulties
Developmental Dyslexia, Reading Problem
Recruiting
Dynamic Assessment of the Risk for Language and Reading Disorders in Monolingual and Multilingual Children
Developmental Dyslexia, Developmental Language Disorder
Not yet recruiting
Trial of Center-Based Early Start Denver Model vs. Pivotal Response Treatment in Children With Autism
Autism Spectrum Disorder (ASD), Autism
Not yet recruiting
Artificial Grammar Learning in Children Who Are Deaf or Hard-of-Hearing: Stimulus Length Effect
Hearing Impaired Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentence recast in people with Developmental Language Disorder and Language Impairment, run by University of Houston 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 7 inclusion and 1 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 10 Mar 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)]). 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 10 Mar 2025.