Testing a Novel Speech Intervention in Minimally Verbal Children With Autism Spectrum Disorder (ASD)
NCT03015272 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2020-05-19
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.
Conditions
Interventions
- BEHAVIORAL
-
Auditory-Motor Mapping Training
AMMT is a novel, intonation-based intervention that is accompanied by simultaneous tapping each spoken syllable on tuned drums, designed to help minimally verbal children between the ages of 5.5 and12.0 years develop and/or improve speech output. AMMT is administered 1-on-1 for 45 min./day, 5 days/week (25 sessions) by researchers trained in the method.
- BEHAVIORAL
-
Speech-Repetition Therapy
SRT is a novel, non-intonation-based intervention designed to help minimally verbal children between the ages of 5.5 and 12 years develop and/or improve speech output. SRT is administered 1-on-1 for 45 min./day, 5 days/week (25 sessions) by researchers trained in this intervention. SRT serves as a control intervention to AMMT.
Sponsors & Collaborators
-
Boston University
collaborator OTHER -
Beth Israel Deaconess Medical Center
lead OTHER
Principal Investigators
-
Gottfried Schlaug, MD, PhD · Beth Israel Deaconess Medical Center/Harvard Medical School
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 66 Months
- Max Age
- 120 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-11-30
- Primary Completion
- 2019-09-30
- Completion
- 2019-12-31
Countries
- United States
Study Locations
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