- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06866223
Emergent Bilinguals: Child Language Proficiency and Language of Treatment
Emergent Bilinguals: the Relationship Between Child Language Proficiency and Language of Treatment on the Outcomes Children with Developmental Language Disorder
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
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Houston, Texas, United States, 77204
- Recruiting
- University of Houston
-
Contact:
- Anny Castilla-Earls, PhD
- Phone Number: 713-7430488
- Email: annycastilla@uh.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
1) children with significant sensory-motor concerns or psychiatric disorders per parent report will not be enrolled.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Monolingual therapy
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).
|
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
|
|
Experimental: Interleaved therapy
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 month before (Pre), 2 weeks before second structure (Mid) and 2 weeks after treatment (Post test)]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)]
|
Calculated from a story retell in English.
Mean length of utterance and subordination index.
|
~1 month before (Pre), 2 weeks before second structure (Mid) and 2 weeks after treatment (Post test)]
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01DC020183 (U.S. NIH Grant/Contract)
- STUDY00002073 (University of Houston)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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:
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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