Vanderbilt University
Nashville, Tennessee, 37203, United States
NCT Number: NCT04066049
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.
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Notify Me30 month–36 month
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37203, United States
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). This 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.
The target population of children for this study is multiply at-risk for persistent language delays and later language-related academic difficulties. First, before age three, the identified children have significant delays in both receptive and expressive language abilities. Significant delays in both domains of language by 30 months of age places children at-risk for persistent language impairment at school entry and beyond. Second, these children's families are low-income ethnic minorities residing in the U.S. As such, these families and children are more likely to live in segregated communities with limited neighborhood resources, poorer quality schools, and less access to quality health care. Finally, these children's caregivers are Spanish-speaking immigrants who are likely to face discrimination based on their own language use and to face cultural and linguistic barriers in accessing needed services for their children. We note that the population for this study differs from children who are considered at-risk because they are from low-income ethnic minority families. The target population for this project is young children who already evidence significant delays in both language understanding and production in addition to coming from low-income families. This is a population for whom there are no current evidence-based interventions and for whom early, effective language intervention is essential to their later academic learning. The intervention, EMT en Español, utilizes intervention strategies adapted from Enhanced Milieu Teaching, an evidence-based naturalistic communication intervention, to promote home language and improve children's language useacross the day in home routines, play, and book sharing in individual sessions with a therapist and in caregiver training sessions. The current study builds on two preliminary studies of EMT in Español and evidence from an RCT of EMT with English-speaking toddlers with receptive and expressive language delays. The caregiver training component of the intervention utilizes an evidence-based caregiver instruction and coaching protocol to deliver the EMT en Español intervention in families' homes in Spanish.
A randomized clinical trial (RCT) design is proposed to compare the effects of EMT in Español to a community business as usual (BAU) control group. The immediate and long-term effects of the intervention on children's language development and on their caregivers' use of naturalistic teaching strategies including linguistic input will be examined over the 18 months of the study. Note that the population of children for this study are monolingual Spanish-speakers at30 months, who may have some limited exposure to English. Children in this study will likely be dual language learners when they enter preschool. All outcomes and measures account for children's language abilities across languages.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
EMT en Español utilizes intervention strategies adapted from Enhanced Milieu Teaching (Kaiser & Hampton, 2016), an evidence-based naturalistic communication intervention, to promote home language and improve children's language use across the day in home routines, play, and book sharing in individual sessions with a therapist and in caregiver training sessions.
Time frame: 5 months
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.
Time frame: 5 months
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.
Time frame: 5 months
Minimum Total Raw Score: 0; Maximum Total Raw Score: 180; Higher scores are considered better outcomes.
Time frame: 17 months
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.
Time frame: 5 months, 11 months, 17 months
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.
Vanderbilt University
Other
EMT en Español: Comprehensive Early Intervention to Support School Readiness Skills for Spanish-speaking Toddlers With Language Delays
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