Clinical trial NCT06416306: Treatment Targets in Spanish and English Bilingual Speech Intervention
Official title: Speech Intervention for Bilingual Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Speech Sound Disorder
Keywords: speech
speech sound disorder
bilingual
treatment targets
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2024-05-16
Enrollment: 16
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Comprehensive Probe or Monitored Sounds Probe
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
References: