- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06416306
Treatment Targets in Spanish and English Bilingual Speech Intervention
Speech Intervention for Bilingual Children
The goal of this clinical trial is to learn which speech treatment targets result in the greatest amount of speech learning in Spanish-English bilingual children with speech sound disorders. The main questions it aims to answer are:
- Does linguistic complexity of the treatment target increase the amount of generalized learning within the treated language?
- Does linguistic complexity of the treatment target increase the amount of generalized speech across languages?
Researchers will compare intervention effects across treatment provided in English and Spanish to see if the effect differs according to the language of intervention.
Participants will:
- Attend between 12 and 18 45-minute speech intervention sessions in Spanish or English for up to 6 weeks
- Attend assessment visits before and after intervention
- Attend follow-up assessment visits 1 month and 2 months after intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a single-subject experimental design with staggered multiple baselines examining speech intervention for Spanish-English bilingual children with speech sound disorders. The study includes two arms based on the language of intervention (Spanish or English). Within each arm are two conditions that manipulate the linguistic complexity of the speech treatment target (simple consonant singleton or complex consonant cluster). Participants will be pseudo-randomly assigned to these arms and conditions.
The primary outcome is system-wide generalization; specifically, a) within-language and b) across-language generalization to untreated sounds. Accuracy data for the dependent variable will be derived from narrow phonetic transcription of participants' productions from speech probes in English and Spanish. The entire generalization probe is administered at each assessment visit (Pre, Post, and 1- and 2-Month Follow-Ups), and shorter subset probes targeting only monitored sounds are administered during Baselines and weekly during Treatment.
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants will be regularly exposed to English for at least 3 months in one of the following ways: a) an English-speaking caregiver or sibling who interacts with the child on a daily basis in English, b) attendance at an English-speaking daycare, preschool, or elementary school.
- Caregivers will have reported concern with their child's speech development and/or reduced intelligibility on the Intelligibility in Context Scale in Spanish or English.
- Participants will present with 5 or more consonants or clusters missing from their phonetic inventories in each language to confirm presence of a speech sound disorder and sufficient gaps in phonological knowledge to warrant treatment.
Exclusion Criteria:
- Participants receiving speech or language treatment elsewhere during their participation in this project.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Spanish Language Intervention
Treatment will be conducted entirely in Spanish, targeting Spanish speech sounds.
Treatment will follow a drill-play format.
|
The treatment will begin with imitation, whereby the child will produce target words following the study clinician's verbal model with 1:1 clinician feedback for the accuracy of the child's productions.
This will include explicit articulatory instruction (i.e., verbal and visual cues) to elicit correct target forms.
When a child achieves 75% accuracy following a verbal model across 2 consecutive sessions or completes the 9th session (whichever is first), treatment will shift to spontaneous production, in which the child will produce target words spontaneously or through elicitation without a verbal model.
Treatment materials will be images of treatment target words, interactive games and stories, and a standard set of toys.
|
Experimental: English Language Intervention
Treatment will be conducted entirely in English, targeting English speech sounds.
Treatment will follow a drill-play format.
|
The treatment will begin with imitation, whereby the child will produce target words following the study clinician's verbal model with 1:1 clinician feedback for the accuracy of the child's productions.
This will include explicit articulatory instruction (i.e., verbal and visual cues) to elicit correct target forms.
When a child achieves 75% accuracy following a verbal model across 2 consecutive sessions or completes the 9th session (whichever is first), treatment will shift to spontaneous production, in which the child will produce target words spontaneously or through elicitation without a verbal model.
Treatment materials will be images of treatment target words, interactive games and stories, and a standard set of toys.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comprehensive Probe or Monitored Sounds Probe
Time Frame: At initial visit, 2-4 times across the 2 weeks prior to intervention, once per week during the 6-week intervention, within 1 week after intervention, 1 month after intervention, and 2 months after intervention
|
Accuracy data for the dependent variable will be derived from narrow phonetic transcription of participants' productions from speech generalization probes in English and Spanish.
Both protocols elicit ~300 word productions and sample each singleton consonant and consonant cluster in the respective language a minimum of three times in every permissible word position.
The entire generalization probe is administered at each assessment visit (Pre, Post, and 1- and 2-Month Follow-Ups), and shorter subset probes targeting only monitored sounds are administered during Baselines and weekly during Treatment.
All transcriptions will be completed by research assistants unaware of the condition (simple or complex treatment target), arm of the study (English or Spanish language of intervention) or phase of the intervention study (Pre, Post, or Follow-up).
|
At initial visit, 2-4 times across the 2 weeks prior to intervention, once per week during the 6-week intervention, within 1 week after intervention, 1 month after intervention, and 2 months after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
- 01466758
- 202109072 (Other Identifier: University of Iowa)
- R21DC021249 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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