EMT en Español for Spanish-speaking Toddlers With Language Delays

NCT04066049 | Completed

• 1 other identifier: R324A190177
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Language Development Disorders

Keywords

Spanish-speaking; caregiver-implemented intervention; bilingual

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Other Outcomes (2)

• Bilingual English-Spanish Assessment (BESA) standard score (0-100)

  17 months

• Composite Executive Function Score

  5 months, 11 months, 17 months

Study Arms (2)

Treatment

ACTIVE COMPARATOR

Participants in the Treatment group will receive a hybrid therapist-implemented and caregiver-implemented intervention 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, and will receive a $50 gift card for participating in each assessment time point, $75 for completing all four assessments, and books and play/activity materials with target word lists in Spanish.

Behavioral: EMT en Español

Control

NO INTERVENTION

Participants in the BAU group will be offered 10 caregiver support sessions after completing the 12-month follow-up. These home-based sessions will emphasize shared book reading, modeling vocabulary for school readiness in play and routines, and include general information for families about options for public school language related services. Each session will last about 30 minutes and be conducted by a trained staff member. Caregivers and children will be assessed at baseline, after the intervention, 6 months after intervention, and 12 months after intervention, and will receive a $50 gift card for participating in each assessment time point, $75 for completing all four assessments, and books and play/activity materials with target word lists in Spanish.

Interventions

EMT en Español BEHAVIORAL

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.

Treatment

Eligibility Criteria

• Age: 30 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vanderbilt University: lead
• Institute of Education Sciences: collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ann P Kaiser, PhdD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

• Tatiana Peredo, PhdD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Standardized and observational measures will be conducted by independent observers and assessors (master's level bilingual speech-language pathologists) who are blind to the experimental conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 22, 2019
• Study Start: December 1, 2019
• Primary Completion: April 30, 2025
• Study Completion: July 31, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)