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RecruitingNCT06416306Updated Nov 3, 2026

Treatment Targets in Spanish and English Bilingual Speech Intervention

A Phase 1 interventional study of Speech Intervention in Speech Sound Disorder, sponsored by Philip Combiths. Recruiting at 1 site in United States. Open to participants aged 3 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Philip Combiths · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started May 2024; still recruiting 2 years 6 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
3 Years to 8 Years
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • Speech Sound Disorder

Keywords

  • speech
  • speech sound disorder
  • bilingual
  • treatment targets
03

In context

Speech Sound Disorder

46 studies on the registry are indexed under Speech Sound Disorder; 16 are open to participants now.

This study's planned enrollment of 16 is below the median of 40 across 39 interventional studies indexed under Speech Sound Disorder.

Browse Speech Sound Disorder studies →

Lead sponsor

This is the only study on the registry with Philip Combiths as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Participants receiving speech or language treatment elsewhere during their participation in this project.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    Spanish Language Intervention

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

    Behavioral: Speech Intervention

  • Experimental
    English Language Intervention

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

    Behavioral: Speech Intervention

Interventions

  • BehavioralSpeech 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.

06

What researchers measure

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).

    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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2024 (actual). Primary completion is estimated for Mar 2027, 34 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2024
First posted
May 16, 2024
StartActual
May 8, 2024
Primary completionEst.
Mar 31, 2027
CompletionEst.
Mar 31, 2027
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and oversight details
1 update, last Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Minor edits only
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06416306
Lead sponsor
Philip Combiths
Responsible party
Philip Combiths (Assistant Professor, University of Iowa) — Sponsor-investigator
First posted
May 16, 2024
Start date
May 8, 2024
Primary completion
Mar 31, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Philip Combiths
Contact
philip-combiths@uiowa.edu
3194674432

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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