EMT en Español for Language Disorder

Overseen By Tatiana Peredo, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University

Disqualifiers: ASD, Down syndrome, cerebral palsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 5 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate a new communication intervention called EMT en Español, designed to help young Spanish-speaking children with language delays improve their language and school readiness skills. The study compares a caregiver and therapist-led intervention with a standard community care approach. Families will participate in assessments over a year and receive support materials for their children's language development. The trial seeks low-income Spanish-speaking families with children aged 30-36 months who have language delays but no other disabilities.

As an unphased trial, this study offers families the opportunity to contribute to important research that could enhance language development support for Spanish-speaking children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this communication intervention is safe for children?

Research shows that EMT en Español, a program designed to assist with language, has been well-received in past studies. Early results suggest it improves communication between caregivers and children, with no major safety issues reported. The program involves therapists and caregivers collaborating to enhance children's language skills. This teamwork approach has not caused any problems, making it a safe choice for families considering participation. Although this trial phase lacks detailed safety data, the absence of negative events in earlier studies suggests it is safe for young children with language delays. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about EMT en Español because it offers a personalized approach to treating language disorders in Spanish-speaking children by integrating caregivers directly into the therapy process. Unlike traditional methods that often rely solely on therapist-led interventions, this treatment combines professional guidance with active caregiver involvement, creating a unique hybrid model. This approach not only aims to improve language skills but also empowers families by providing them with practical tools and strategies to support their children's language development in everyday environments.

What evidence suggests that EMT en Español could be an effective treatment for language disorder?

Studies have shown that EMT en Español can greatly improve language skills in Spanish-speaking toddlers. In this trial, participants in the Treatment group will receive EMT en Español, which has helped children understand more words than those not in the program. Research also shows that this method enhances communication between caregivers and children, which is crucial for language learning. The program equips Spanish-speaking caregivers with techniques that effectively support their children's language development. Overall, evidence suggests that EMT en Español can help young children with language delays improve their language skills and prepare for school. ^{1 2 3 6 7}

Who Is on the Research Team?

Tatiana Peredo, PhdD

Principal Investigator

Vanderbilt University

Ann Kaiser, PhD

Principal Investigator

Vanderbilt University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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 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

The child has another condition like autism, Down syndrome, cerebral palsy, blindness, or deafness.

The child's thinking and understanding skills are not close to the average range as measured by the Leiter-R test.

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention

Baseline assessments conducted for caregivers and children

1-2 weeks

1 visit (in-person)

Treatment

Participants receive the EMT en Español intervention, implemented by both therapist and caregiver

5 months

Multiple sessions (in-person)

Post-intervention

Assessments conducted immediately after the intervention to evaluate immediate effects

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for long-term effects of the intervention

12 months

Assessments at 6 months and 12 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• EMT en Español

Trial Overview 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.

How Is the Trial Designed?

Group I: Control Active Control 1 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: Treatment Active Control 1 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.

Who Is Running the Clinical Trial?

Vanderbilt University

Lead Sponsor

Trials

714

Recruited

6,143,000+

Institute of Education Sciences

Collaborator

Trials

10

Recruited

3,200+

Institute of Education Sciences

Collaborator

Trials

4

Recruited

1,500+

Published Research Related to This Trial

In a meta-analysis of single-case studies involving 142 patients, improvement in the production of treated verbs was linked to pre-treatment scores in verb comprehension and word repetition, as well as the frequency of treatment sessions, suggesting that these factors are crucial for recovery.

For the production of untreated verbs, which involved 166 patients, improvement was associated with the use of morphological cues and the presence of grammatical impairment, indicating that different mechanisms may underlie recovery for treated versus untreated language outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Production of Treated and Untreated Verbs in Aphasia: A Meta-Analysis. de Aguiar, V., Bastiaanse, R., Miceli, G.[2020]

In a case series study involving seven participants with long-standing aphasia due to a cerebrovascular accident, all individuals showed improvement in word finding after receiving home-based language therapy monitored via the Internet.

Additionally, four out of the seven participants experienced enhancements in their overall communication skills, suggesting that this therapy approach can be effective for individuals with aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of computerised rehabilitation for long-term aphasia: a case series study. Mortley, J., Wade, J., Enderby, P., et al.[2018]

The study aims to create a comprehensive database of individual participant data (IPD) from various studies on speech and language therapy (SLT) for people with aphasia after stroke, which will help identify predictors of recovery and effective therapy components.

By using meta- and network meta-analysis, the research will explore how individual characteristics and specific SLT interventions contribute to improvements in language recovery, ultimately aiming to optimize treatment strategies for aphasia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RELEASE: a protocol for a systematic review based, individual participant data, meta- and network meta-analysis, of complex speech-language therapy interventions for stroke-related aphasia. Brady, MC., Ali, M., VandenBerg, K., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04066049

EMT en Español for Spanish-speaking Toddlers With ... The proposed randomized trial compares the effects of a caregiver plus therapist implemented EMT en Español intervention to a community based "business as usual ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885200621001022

Teaching spanish‐speaking caregivers to implement EMT ... Overall, children in the intervention condition had significantly higher receptive vocabulary scores and performed better than children in the control condition ...

3. ies.ed.gov ies.ed.gov/use-work/awards/emt-en-espanol-comprehensive-early-intervention-support-school-readiness-skills-spanish-speaking

EMT en Español: Comprehensive Early Intervention to ... Pilot data suggest that the Spanish adaptation, EMT en Español, leads to improvements in caregiver-child communication during interactions, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12021949/

EMT en Español Para Autismo The primary purpose of the current pilot study was to test the effects of an adapted and collaborative intervention model with a systematic teaching approach.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8765734/

Teaching Spanish-Speaking Caregivers to Implement EMT ... Results revealed the effectiveness of EMT en Español for increasing Spanish-speaking caregivers' behaviors that support their children's language. Caregivers ...

6. ir.vanderbilt.edu ir.vanderbilt.edu/bitstreams/0b8847ec-bee4-4952-aae3-cf6a9577a4ab/download

Dosage, Fidelity, and Child Outcomes in a Small ... Data for this study were collected in a small RCT examining the effects of teaching. Spanish-speaking caregivers to use EMT en Español with ...

7. researchgate.net researchgate.net/publication/379808418_EMT_en_Espanol_Para_Autismo_A_Collaborative_Communication_Intervention_Approach_and_Single_Case_Design_Pilot_Study

(PDF) EMT en Español Para Autismo: A Collaborative ... PDF | The primary purpose of the current pilot study was to test the effects of an adapted and collaborative intervention model with a ...