Clinical trial NCT04066049: EMT en Español for Spanish-speaking Toddlers With Language Delays
Official title: EMT en Español: Comprehensive Early Intervention to Support School Readiness Skills for Spanish-speaking Toddlers With Language Delays
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Language Development Disorders
Keywords: Spanish-speaking
caregiver-implemented intervention
bilingual
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Institute of Education Sciences
First posted: 2019-08-22
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants in the Treatment group will receive a hybrid therapist-implemented and caregiver-implemented intervention and be compared to a BAU control group. Caregivers and children will be assessed at baseline, after the intervention, 6 months after intervention, and 12 months after intervention.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Unprompted Number of Different Conceptual Words across English and Spanish from 2 20-minute standardized play-based Language Samples with a trained assessor.
timeFrame: 5 months
measure: Number of language targets used across 2 20-minute standardized play-based language samples with a trained assessor.
timeFrame: 5 months
measure: Total raw score from Receptive and Expressive One-Word Picture Vocabulary Tests - Spanish Bilingual Edition (ROWPVT-SBE)
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
measure: Bilingual English-Spanish Assessment (BESA) standard score (0-100)
timeFrame: 17 months
measure: Composite Executive Function Score
timeFrame: 5 months, 11 months, 17 months
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Ann P Kaiser, PhdD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Tatiana Peredo, PhdD
role: PRINCIPAL_INVESTIGATOR
References: