Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
Study NCT ID:
NCT06416306
Status:
RECRUITING
Last Update Posted:
2025-09-05
First Post:
2024-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment Targets in Spanish and English Bilingual Speech Intervention
Sponsor:
Philip Combiths
Organization:
Study Overview
Official Title:
Speech Intervention for Bilingual Children
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
* 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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R21DC021249 | NIH | None | https://reporter.nih.gov/quic… | View |