NCT06866223

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 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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
26mo left

Started Nov 2024

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 Progress41%
Nov 2024Jul 2028

Study Start

First participant enrolled

November 11, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

3.1 years

First QC Date

March 4, 2025

Last Update Submit

March 4, 2025

Conditions

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)

  • Mean Length of Utterance and Subordination Index in English

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

Study Arms (2)

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).

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.

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

Interleaved therapyMonolingual therapy

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 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

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)

University of Houston

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

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 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 10, 2025

Study Start

November 11, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

March 10, 2025

Record last verified: 2025-03

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. Supporting Information:

Locations