EMT en Español for Language Disorder

Overseen By Tatiana Peredo, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University

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

Compensation: Varies

Number of Visits: 8

Duration: 5 months

90 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment EMT en Español for Language Disorder?

Research shows that speech and language therapy can help people with language difficulties, like those with aphasia (a language disorder often caused by stroke), improve their communication skills. Although the studies focus on aphasia, they suggest that structured language therapy, similar to EMT en Español, can be beneficial for language disorders. ^{1 2 3 4 5}

How is the treatment EMT en Español unique for language disorder?

EMT en Español is unique because it specifically addresses language disorders in Spanish-speaking individuals by focusing on enhancing communication skills in their native language, which is different from other treatments that may not be tailored to non-English speakers. ^{6 7 8 9 10}

Research Team

Tatiana Peredo, PhdD

Principal Investigator

Vanderbilt University

Ann Kaiser, PhD

Principal Investigator

Vanderbilt University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of computerised rehabilitation for long-term aphasia: a case series study. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Outcome measurement in speech and language therapy: a digital journey. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Outcome measures for aphasia therapy: it's not what you do, it's the way that you measure it. [2015]

4. England 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. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Improving Production of Treated and Untreated Verbs in Aphasia: A Meta-Analysis. [2020]

6. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Correlators of achievement in English for medical purposes among baccalaureate nursing students. [2010]

7. United States pubmed.ncbi.nlm.nih.gov

Improving Equity of Care for Patients with Limited English Proficiency Using Quality Improvement Methodology. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Perceptions of Prehospital Care for Patients With Limited English Proficiency Among Emergency Medical Technicians and Paramedics. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Eliminating barriers for patients with limited English proficiency. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Improving Identification of Interpreter Need in the Pediatric Emergency Department. [2023]