Treatment Targets in Spanish and English Bilingual Speech Intervention

NCT ID: NCT06416306

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-08
• Study Completion Date: 2027-03-31

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.

Conditions

Speech Sound Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Spanish Language Intervention

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

Group Type: EXPERIMENTAL

Speech Intervention

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Speech Intervention

Intervention Type: 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.

Interventions

Speech Intervention

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Philip Combiths

OTHER

Sponsor Role: lead

Responsible Party

Philip Combiths

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Iowa

Iowa City, Iowa, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Philip Combiths

Role: CONTACT

philip-combiths@uiowa.edu

3194674432

Facility Contacts

Philip Combiths

Role: primary

philip-combiths@uiowa.edu

3194674432

Other Identifiers

R21DC021249

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202109072

Identifier Type: -

Identifier Source: org_study_id