Recruiting
Phase 1

Bilingual Speech Intervention

Sponsor:

Philip Combiths

Code:

NCT06416306

Conditions

Speech Sound Disorder

Eligibility Criteria

Sex: All

Age: 3 - 8

Healthy Volunteers: Not accepted

Interventions

Speech Intervention

Study Details

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

Study ID

NCT06416306

Start date

May 8, 2024

Status verified date

Aug, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 8

Healthy Volunteers: Not accepted

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 Design

Enrollment

16 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Spanish Language Intervention

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

experimental: English Language Intervention

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

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Philip Combiths

3194674432philip-combiths@uiowa.edu

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Philip Combiths

3194674432philip-combiths@uiowa.edu

Principal Investigator:

Philip Combiths

More Information

Sponsor

Philip Combiths

Last update posted

Sep 5, 2025

Last verified

Aug, 2025

Keywords

  • speech
  • speech sound disorder
  • bilingual
  • treatment targets

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Philip Combiths on 2025-09-05.