EMT en Español for Spanish-speaking Toddlers With Language Delays (NCT04066049) | Clinical Trial Compass
CompletedNot Applicable
EMT en Español for Spanish-speaking Toddlers With Language Delays
United States81 participantsStarted 2019-12-01
Plain-language 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.
Who can participate
Age range
30 Months – 36 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 crit…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
2
Number of language targets used across 2 20-minute standardized play-based language samples with a trained assessor.
Timeframe: 5 months
3
Total raw score from Receptive and Expressive One-Word Picture Vocabulary Tests - Spanish Bilingual Edition (ROWPVT-SBE)