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Clinical Trials/NCT06416306
NCT06416306
Recruiting
Phase 1

Speech Intervention for Bilingual Children

Philip Combiths1 site in 1 country16 target enrollmentMay 8, 2024

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Speech Sound Disorder
Sponsor
Philip Combiths
Enrollment
16
Locations
1
Primary Endpoint
Comprehensive Probe or Monitored Sounds Probe
Status
Recruiting
Last Updated
7 months ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
May 8, 2024
End Date
March 31, 2027
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Philip Combiths
Responsible Party
Sponsor Investigator
Principal Investigator

Philip Combiths

Assistant Professor

University of Iowa

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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).

Study Sites (1)

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