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NCT03015272 · ClinicalTrials.gov registry record · Phase 2
Testing a Novel Speech Intervention in Minimally Verbal Children With Autism Spectrum Disorder (ASD)
A Phase 2 study of Autism, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 2
- Study locations
NCT03015272: Completed Phase 2 study of Autism, sponsored by Beth Israel Deaconess Medical Center.
NCT03015272 is a Phase 2 study of Autism that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 14 participants, below the 183-participant average among 104 other Autism trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03015272, a Phase 2 study of Autism, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of the Novel Language Intervention for minimally verbal children with Autism Spectrum Disorder (ASD) is to test the efficacy of one experimental treatment (AMMT) compared to baseline assessments and compare the AMMT efficacy to a control intervention (SRT), both treatments were designed to facilitate speech output in minimally verbal 5.5 to 12.0 year olds. This study aims to compare the two interventions (one intonation-based; the other non-intonation-based) in a single-blind, randomized controlled trial (RCT) that includes a comprehensive baseline assessment battery, 25 intensive 1-on-1 treatment sessions conducted 5 days/week, and a series of probe assessments administered at multiple timepoints pre-, during, and post-therapy. Despite the complex needs of minimally verbal children with ASD and the wide variety of treatments available to address many of those needs, there is still a great need for effective methods that promote the development of speech sounds and facilitate the production of those sounds in this growing population. While the primary aim of this RCT is to investigate the effects of AMMTversus a control intervention (SRT) on minimally verbal children with ASD and compare the two interventions to determine whether one is more effective than the other, this study also aims to examine whether baseline cognitive skills, speech praxis, joint attention abilities and/or neural architecture can predict the effects of treatment with AMMT or SRT in minimally verbal children with ASD.
Primary Outcome
Approximately correct consonant-vowel syllables of 30 target words/phrases (15 Trained; 15 Untrained) presented using visual clues during at least 3 baseline assessments, multiple interim assessments (after 10, 15, 20, 25 therapy sessions), and one post-treatment assessment (4 weeks after the end of therapy).
Conditions Studied
Interventions
- BEHAVIORAL Auditory-Motor Mapping Training
- BEHAVIORAL Speech-Repetition Therapy
Study Locations (2)
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Boston University, Autism Center of Excellence - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2014-11 |
| Est. Completion | 2019-12 |
| Phase | Phase 2 |
What the finished NCT03015272 record still lists
NCT03015272 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 183-participant average among 104 other Autism trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Autism appearing as the primary indexed condition, and to 2 interventions - of which Auditory-Motor Mapping Training is the first listed.
NCT03015272 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03015272 about?
NCT03015272 is a clinical study titled "Testing a Novel Speech Intervention in Minimally Verbal Children With Autism Spectrum Disorder (ASD)". The goal of the Novel Language Intervention for minimally verbal children with Autism Spectrum Disorder (ASD) is to test the efficacy of one experimental treatment (AMMT) compared to baseline assessments and compare the AMMT efficacy to a control intervention (SRT), both treatments were designed to ...
What is the current status of trial NCT03015272?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2014-11. Estimated completion is 2019-12.
What conditions does trial NCT03015272 study?
This clinical trial studies the following conditions: Autism.
What interventions are being tested in trial NCT03015272?
The interventions under investigation include: Auditory-Motor Mapping Training (BEHAVIORAL), Speech-Repetition Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT03015272?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03015272 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03015272's enrollment target sits among peer trials
14 97th of 104 higher than 7 of 104 other Autism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism 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.
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