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NCT03935620 · ClinicalTrials.gov registry record · NA

Delivering Early Intervention to Children With Down Syndrome

A NA study, sponsored by Oregon Health and Science University.

Completed
Registry status
NA
Development phase
3
Enrollment target

NCT03935620 is a NA study that has completed, run by Oregon Health and Science University. The registered enrollment target is 3 participants.

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The verdict

NCT03935620, a NA study, has completed, sponsored by Oregon Health and Science University.

COMPLETED
Registry status
NA
Development phase
3 participants
Enrollment target

Study Summary

Children with Down syndrome (DS) are at risk for significant language and communication impairments. Enhancing the service delivery of early intervention for children with DS is a key research and policy issue given the prevalence and detrimental effects of persistent language impairments. Using a telemedicine approach allows clinicians to provide evidence-based treatment to families from a wide geographic area in Oregon who may not otherwise have access to a language intervention specialized for children with DS. Our innovative project involves the creation of a new treatment optimized for children with DS, as it will be the first study that translates an existing evidence-based language intervention-Enhanced Milieu Teaching (EMT) into a telemedicine model. The goal of this study is to examine whether a telemedicine approach is effective for training parents to implement EMT language support strategies and whether changes in parent behavior are associated with child communication and language growth. The investigators will pilot the telemedicine initiative to provide early intervention services to ten children with DS (aged 18- 48 months) and their families who live in rural and /or under-served areas of Oregon. The investigators will use single-case research design methodology to pilot this intervention research. The investigators will use secure video-teleconferencing technology to provide EMT. Clinicians will provide EMT to parents through interactive coaching, teaching them how to foster their children's social communication and language skills. Outcomes will focus on parents' use of language support strategies and children's social communication and language skills. Delivering early intervention to children with DS and providing parent-training at a distance using a telemedicine approach has the potential to transform the delivery of early language interventions for children with DS. Results of this study will directly inform the development and refinement of

Interventions

  • BEHAVIORAL Enhanced Milieu teaching

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2019-06-01
Est. Completion 2021-12-01
Phase NA

What the Registry Record Tells You About NCT03935620

The ClinicalTrials.gov registry entry for NCT03935620 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oregon Health and Science University, which has 546 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Enhanced Milieu teaching is the first listed.

NCT03935620 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03935620 about?

NCT03935620 is a clinical study titled "Delivering Early Intervention to Children With Down Syndrome". Children with Down syndrome (DS) are at risk for significant language and communication impairments. Enhancing the service delivery of early intervention for children with DS is a key research and policy issue given the prevalence and detrimental effects of persistent language impairments. Using a t...

What is the current status of trial NCT03935620?

This trial is currently completed. It is a NA study. The enrollment target is 3 participants. The study started on 2019-06-01. Estimated completion is 2021-12-01.

What interventions are being tested in trial NCT03935620?

The interventions under investigation include: Enhanced Milieu teaching (BEHAVIORAL).

Who is sponsoring clinical trial NCT03935620?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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