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Behavioral Intervention
EMT en Español for Language Disorder
N/A
Recruiting
Led By Ann P Kaiser, PhdD
Research Sponsored by Vanderbilt University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The child is between 30-36 months old
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 months, 11 months, 17 months
Awards & highlights
Study Summary
This trial is testing a new communication intervention to improve language and school readiness skills in low-income Spanish-speaking children with receptive and expressive language delays, compared to a control group.
Who is the study for?
This trial is for low-income Spanish-speaking families with toddlers aged 30-36 months who have language delays but normal cognitive skills. The child must be primarily spoken to in Spanish and show significant expressive and receptive language delays. A consistent caregiver must be willing to participate.Check my eligibility
What is being tested?
The study tests 'EMT en Español', a communication intervention aimed at improving language and school readiness in toddlers with language delays. It involves caregivers and therapists, compared to usual community services, over several assessments up to a year.See study design
What are the potential side effects?
Since this is an educational intervention rather than a medical treatment, traditional side effects are not applicable. However, there may be varying levels of improvement or no change in the child's language abilities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is between 2.5 and 3 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 months, 11 months, 17 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 months, 11 months, 17 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of language targets used across 2 20-minute standardized play-based language samples with a trained assessor.
Total raw score from Receptive and Expressive One-Word Picture Vocabulary Tests - Spanish Bilingual Edition (ROWPVT-SBE)
Unprompted Number of Different Conceptual Words across English and Spanish from 2 20-minute standardized play-based Language Samples with a trained assessor.
Secondary outcome measures
Number of language targets used across the English and Spanish narrative retell measures.
Unprompted Number of Different Conceptual Words across English and Spanish taken from the English and Spanish narrative retell measures.
Other outcome measures
Bilingual English-Spanish Assessment (BESA) standard score (0-100)
Composite Executive Function Score
Trial Design
2Treatment groups
Active Control
Group I: ControlActive Control1 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.
Group II: TreatmentActive Control1 Intervention
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.
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Who is running the clinical trial?
Institute of Education SciencesFED
8 Previous Clinical Trials
3,122 Total Patients Enrolled
Vanderbilt UniversityLead Sponsor
704 Previous Clinical Trials
6,143,273 Total Patients Enrolled
Ann P Kaiser, PhdDPrincipal InvestigatorVanderbilt University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- The child has another condition like autism, Down syndrome, cerebral palsy, blindness, or deafness.The child has difficulty speaking and understanding language, as measured by a specific test.The child's caregivers speak Spanish as the main language at home, according to the Home Language Scale.The child's thinking and understanding skills are not close to the average range as measured by the Leiter-R test.My child is between 2.5 and 3 years old.The child's thinking and problem-solving abilities are close to the average range when tested with the Leiter-R assessment.My child is older than 3 years.The child does not have significant delays in speaking and understanding language compared to other kids their age.The caregiver mainly speaks a language other than Spanish to the child, as determined by the Home Language Scale.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has recruitment commenced for this research endeavor?
"According to the clinicaltrial.gov website, this experiment is still seeking participants. It was initially unveiled on the 1st of December 2019 and last modified on October 17th 2022."
Answered by AI
For whom is this research being conducted?
"This trial seeks 90 infants aged between 2.5 and 3 years old, who are displaying language delay beyond 1.5 standard deviations of the mean as measured by Preschool Language Scale- 5th edition Spanish, have cognitive skills close to the mean according to Leiter-R test results, do not possess any other disabilities such as ASD or Down syndrome and whose family is economically disadvantaged (income up to two times federal poverty level)."
Answered by AI
Are elderly individuals being incorporated into this clinical investigation?
"According to the established parameters, potential participants must be between 30 and 36 months old in order to join this clinical trial."
Answered by AI
How many individuals are actively participating in this investigation?
"Affirmative. According to the records posted on clinicaltrials.gov, this medical trial is presently recruiting participants; it was first published in December of 2019 and last updated October 17th 2022. Ninety individuals are required for enrollment at a single site."
Answered by AI
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