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NCT02158390 · ClinicalTrials.gov registry record · NA
Phenotypic Specific Communication Intervention for Children With Down Syndrome
A NA study, sponsored by Vanderbilt University.
- Completed
- Registry status
- NA
- Development phase
- 78
- Enrollment target
NCT02158390: Completed NA study, sponsored by Vanderbilt University.
NCT02158390 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 78 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02158390, a NA study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- NA
- Development phase
- 78 participants
- Enrollment target
Study Summary
Children with Down syndrome (DS) have greater difficulty acquiring expressive language than is predicted by their general cognitive abilities and language comprehension (Miller, 1999). To date, interventions to improve communication outcomes for children with DS have met with only modest success. The proposed study is a randomized controlled trial of an early communication intervention combining two evidence-based treatments that teach expressive communication (Enhanced Milieu Teaching; EMT) and joint attention/symbolic play (Joint Attention Symbolic Play Engagement and Regulation; JASPER) using a dual mode (words +AAC). The intervention (a) teaches the foundations of communication (joint attention, play), (b) builds on positive child characteristics of social attention, (c) uses naturalistic strategies to increase the rate and complexity of communication and increase task engagement, (d) addresses the potential value of adding visual support (AAC) to spoken communication, and (e) includes parents as implementers of the intervention to promote generalization across settings and activities, and to ensure maintenance over time. It is hypothesized that children with DS enrolled in the intervention will have better language and communication skills at the end of treatment and followup than children in the BAU comparison group.The study will enroll 82 30 to 54 month old children with DS who have fewer than 20 words. Examining predictors of response to treatment and the effects of treatment on executive functioning will inform both theory and practice.
Primary Outcome
Spoken language is measured by transcribing child utterances ( spoken and AAC generated ) during 20 minute naturalistic language samples. Linguistic analysis are automated, via SALT.
Interventions
- BEHAVIORAL Jasper-EMT with words and AAC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2014-06 |
| Est. Completion | 2018-02-06 |
| Phase | NA |
What the finished NCT02158390 record still lists
NCT02158390 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Jasper-EMT with words and AAC is the first listed.
NCT02158390 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02158390 about?
NCT02158390 is a clinical study titled "Phenotypic Specific Communication Intervention for Children With Down Syndrome". Children with Down syndrome (DS) have greater difficulty acquiring expressive language than is predicted by their general cognitive abilities and language comprehension (Miller, 1999). To date, interventions to improve communication outcomes for children with DS have met with only modest success. Th...
What is the current status of trial NCT02158390?
This trial is currently completed. It is a NA study. The enrollment target is 78 participants. The study started on 2014-06. Estimated completion is 2018-02-06.
What interventions are being tested in trial NCT02158390?
The interventions under investigation include: Jasper-EMT with words and AAC (BEHAVIORAL).
Who is sponsoring clinical trial NCT02158390?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02158390's enrollment target sits among peer trials
78 1060th of 2000 higher than 939 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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