Treatment Targets in Spanish and English Bilingual Speech Intervention

NCT06416306 | Recruiting Phase 1

• 2 other identifiers: 202109072R21DC021249
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Conditions

Speech Sound Disorder

Keywords

speech; speech sound disorder; bilingual; treatment targets

Outcome Measures

Primary Outcomes (1)

• Comprehensive Probe or Monitored Sounds Probe

  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

Study Arms (2)

Spanish Language Intervention

EXPERIMENTAL

Treatment will be conducted entirely in Spanish, targeting Spanish speech sounds. Treatment will follow a drill-play format.

Behavioral: Speech Intervention

English Language Intervention

EXPERIMENTAL

Treatment will be conducted entirely in English, targeting English speech sounds. Treatment will follow a drill-play format.

Behavioral: Speech Intervention

Interventions

Speech Intervention BEHAVIORAL

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.

English Language Intervention; Spanish Language Intervention

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Participants receiving speech or language treatment elsewhere during their participation in this project.

Sponsors & Collaborators

• Philip Combiths: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Speech Sound Disorder; Speech

Condition Hierarchy (Ancestors)

Communication Disorders; Neurodevelopmental Disorders; Mental Disorders; Verbal Behavior; Communication; Behavior

Central Study Contacts

Philip Combiths

CONTACT

3194674432; philip-combiths@uiowa.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcomes will be determined from phonetic transcription of participants' speech during assessment sessions. 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). The participant will be unaware of the relative complexity of their treatment target (i.e., condition: simple or complex).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two prospective treatment studies that share an identical study design, differing only in the language of treatment (Spanish or English). Both studies will employ a within- and across-subjects, single-subject experimental design (SSED) with multiple staggered baselines across two conditions (singleton consonant target vs. consonant cluster target).

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 16, 2024
• Study Start: May 8, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)