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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06085300
Other study ID # STUDY00002073
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 8, 2023
Est. completion date May 1, 2028

Study information

Verified date September 2023
Source University of Houston
Contact Anny Castilla-Earls
Phone 713-743-0488
Email annycastilla@uh.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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 thereā€¦). 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date May 1, 2028
Est. primary completion date May 1, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 6 Years
Eligibility 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 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 Design


Intervention

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 .

Locations

Country Name City State
United States School Districst Houston Texas

Sponsors (3)

Lead Sponsor Collaborator
University of Houston National Institute on Deafness and Other Communication Disorders (NIDCD), University of Delaware

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. ~1 month before (Pre), 2 weeks before second structure (Mid) and 2 weeks after treatment (Post test)
Secondary 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. ~1 month before (Pre), 2 weeks before second structure (Mid) and 2 weeks after treatment (Post test)
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