NCT06085300

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
25mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Aug 2023May 2028

Study Start

First participant enrolled

August 8, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

4.7 years

First QC Date

October 5, 2023

Last Update Submit

January 12, 2025

Conditions

Keywords

developmental language disorderbilingual childrensentence recastBilingual proficiencyLanguage transfer

Outcome Measures

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.

    ~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

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

Study Arms (3)

sentence recast in Spanish only

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 Spanish.

Behavioral: Sentence recast

sentence recast in English only

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 English therapy will have the entire treatment session conducted in English.

Behavioral: Sentence recast

sentence recast - Bilingual (Spanish+English) intervention

EXPERIMENTAL

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

Sentence recastBEHAVIORAL

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 .

sentence recast - Bilingual (Spanish+English) interventionsentence recast in English onlysentence recast in Spanish only

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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 bilingual, that is children must be producing at least simple sentences in spontaneous speech in both Spanish and English, or understand English and Spanish.
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School Districst

Houston, Texas, 77204, United States

RECRUITING

MeSH Terms

Conditions

Language Development DisordersLanguage Disorders

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Anny Castilla-Earls

CONTACT

Paula Nino Kher

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Participants will be randomly assigned to one of three conditions: monolingual recast therapy delivered in English, monolingual recast therapy delivered in Spanish, or bilingual therapy (Spanish+English). 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 16, 2023

Study Start

August 8, 2023

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
One year after final data collection
Access Criteria
IRB approval for access to some data.

Locations