NCT06416306 Treatment Targets in Spanish and English Bilingual Speech Intervention
| NCT ID | NCT06416306 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Philip Combiths |
| Condition | Speech Sound Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2024-05-08 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 16 participants in total. It began in 2024-05-08 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06416306 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 8 Years, studying Speech Sound Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06416306 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06416306 currently recruiting?
Yes, NCT06416306 is actively recruiting participants. Contact the research team at philip-combiths@uiowa.edu for enrollment information.
Where is the NCT06416306 trial being conducted?
This trial is being conducted at Iowa City, United States.
Who is sponsoring the NCT06416306 clinical trial?
NCT06416306 is sponsored by Philip Combiths. The trial plans to enroll 16 participants.