Speech Sound DisorderPhase 1NCT06416306
Treatment Targets in Spanish and English Bilingual Speech Intervention
A Phase 1 study testing Speech Intervention in people with Speech Sound Disorder, run by Philip Combiths at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Speech Sound Disorder
- What is being tested?
- Speech Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2024to 31 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Participants receiving speech or language treatment elsewhere during their participation in this project.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Philip Combiths, 3194674432, philip-combiths@uiowa.edu
Philip Combiths
About this study
Official title: Speech Intervention for Bilingual Children
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?
Read more
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.
- Conditions
- Speech Sound Disorder
- Being tested
- Speech Intervention
- Keywords
- speech, speech sound disorder, bilingual, treatment targets
- Medical subject headings
- Speech Sound Disorder, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Spanish Language Intervention | Experimental | Treatment will be conducted entirely in Spanish, targeting Spanish speech sounds. Treatment will follow a drill-play format. Receives: 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. Receives: Behavioral: Speech Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start8 May 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech Sound DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philip Combiths
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor-investigator, Philip Combiths, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06416306
- Sponsor's protocol ID
- 202109072
- Other IDs
- R21DC021249
- Status last verified
- Oct 2026
- First submitted
- 7 May 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Intervention for Bilingual Children
- ClinicalTrials.gov ID
- NCT06416306
- Acronym / sponsor ID
- 202109072
- Conditions
- Speech Sound Disorder
- Keywords
- speech, speech sound disorder, bilingual, treatment targets
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Philip CombithsUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 8 May 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Spanish Language Intervention | Experimental | Behavioral: Speech InterventionTreatment will be conducted entirely in Spanish, targeting Spanish speech sounds. Treatment will follow a drill-play format. |
| English Language Intervention | Experimental | Behavioral: Speech InterventionTreatment will be conducted entirely in English, targeting English speech sounds. Treatment will follow a drill-play format. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants receiving speech or language treatment elsewhere during their participation in this project.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech InterventionThe 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. | Behavioural | English Language Intervention, Spanish Language Intervention |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Speech Sound Disorder
RecruitingPhase 2
Visual-acoustic Intervention With Service Delivery In-person and Via Telepractice Trial
Speech Sound Disorder
Recruiting
Feasibility and Preliminary Effects of a Therapeutic Approach Using Ultrasound Visual Biofeedback in Children With AFI: a Pilot Randomized Clinical Trial.
Childhood Apraxia of Speech, Speech Sound Disorders
Recruiting
Improving Spatial Perception and Speech Understanding in Multitalker Mixtures
Hearing Loss
Recruiting
BiOfeedback, Online for Sibilant Treatment
Speech Sound Disorder
Recruiting
Online Rotating Delivery of Perception/Production Enhanced Treatment for Rhotics
Speech Sound Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Speech Intervention in people with Speech Sound Disorder, run by Philip Combiths at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philip Combiths (3194674432, philip-combiths@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.