Language Development Disorders Clinical Trial
Official title:
EMT en Español: Comprehensive Early Intervention to Support School Readiness Skills for Spanish-speaking Toddlers With Language Delays
The goal of the study is to conduct an initial efficacy study of a promising therapist and caregiver-implemented communication intervention to improve language and school readiness skills in low-income Spanish-speaking children with receptive and expressive language delays (ages 30 to 36 months). The proposed randomized trial compares the effects of a caregiver plus therapist implemented EMT en Español intervention to a community based "business as usual" control group at four time points (pre- intervention, post-intervention, 6 month follow-up, 12 month follow-up) in a sample of 84 low-income, Spanish-speaking families and their toddlers with receptive and expressive language delays.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | July 31, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Months to 36 Months |
Eligibility | Inclusion Criteria: - Spanish is the primary language spoken to the child by caregivers as measured by the Home Language Scale - The child demonstrates expressive and receptive language delays (at least 1.5 standard deviations below the mean n each domain as measured on the Preschool Language Scale- 5th edition Spanish) - The child demonstrates cognitive skills within 1 standard deviation of the mean as measured by the Leiter-R - The child is between 30-36 months old - The child does not have any other disabilities (e.g. ASD, Down syndrome, cerebral palsy, blindness, deafness) - There is one consistent caregiver willing to participate in training and assessments - The family meets criteria for low-income status (i.e., income is up to 2 times federal poverty level for a family of that size) Exclusion Criteria: - Spanish is not primary language spoken to the child by caregiver as measured by the Home Language Scale - The child does not demonstrate expressive and receptive language delays (at least 1.5 stand deviations below the mean n each domain as measured on the Preschool Language Scale- 5th edition Spanish) - The child does not demonstrate cognitive skills within 1 standard deviation of the mean as measured by the Leiter-R - The child is over 36 months old - The child has another disability (e.g. ASD, Down syndrome, cerebral palsy, blindness, deafness) - There is not a consistent caregiver willing to participate in training and assessments - The family does not meet criteria for low-income status (i.e. income is more than 2 times the federal poverty level for a family of that size) |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University | Institute of Education Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Bilingual English-Spanish Assessment (BESA) standard score (0-100) | The BESA is designed to be used with children who speak English, Spanish, or both.
The BESA subtests are psychometrically sound and yield scaled and standard scores for each of the domain tests (phonology, morphosyntax, and semantics). The BESA is specifically designed to assess speech and language in English-Spanish bilingual children's two languages. The primary use of the BESA is to identify phonological and/or language impairment in bilingual and English language learner (ELL) children via a standardized protocol. The objective scores obtained on the BESA across three domains can be used in combination with clinical observations and language samples, as well as with other standardized measures, to identify children with speech and/or language impairment. Through use of a combination of BESA subtests, clinicians can document children's speech and language strengths and weaknesses. A higher score is considered better than a lower score. |
17 months | |
Other | Composite Executive Function Score | Composite executive function score taken from a Snack Delay Task and Head-Shoulders-Knees-Toes (HSKT) administered by a trained assessor, and the Behavior Rating Inventory of Executive Function Preschool (BRIEF-P) Spanish completed by the parent. The Snack Delay Task and BRIEF-P are administered at 5 months, 11 months and 17 months. The HSKT is only administered at 17 months. | 5 months, 11 months, 17 months | |
Primary | Unprompted Number of Different Conceptual Words across English and Spanish from 2 20-minute standardized play-based Language Samples with a trained assessor. | The non-imitated, non-prompted number of different conceptual words spoken by the child across Spanish and English taken from a combined sample of 1 20-minute play-based Language Sample administered in Spanish and 1 20-minute play-based Language Sample administered in English. | 5 months | |
Primary | Number of language targets used across 2 20-minute standardized play-based language samples with a trained assessor. | The number of specific language targets in English and Spanish, including words and phrases individualized to the child based on their level of language, taken from a combined sample of 1 20-minute play-based Language Sample administered in Spanish and 1 20-minute play-based Language Sample administered in English. | 5 months | |
Primary | Total raw score from Receptive and Expressive One-Word Picture Vocabulary Tests - Spanish Bilingual Edition (ROWPVT-SBE) | Minimum Total Raw Score: 0; Maximum Total Raw Score: 180; Higher scores are considered better outcomes. | 5 months |
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