Testing a Novel Speech Intervention in Minimally Verbal Children With Autism Spectrum Disorder (ASD)

Completed · Phase 2/Phase 3

Conditions studied: Autism

In brief

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.

Key facts

Study ID

NCT03015272

Run by

Beth Israel Deaconess Medical Center

People needed

14

Starts

2014-11-01

Expected to finish

2019-12-01

Last updated by the study team

2020-05-19

Who can join

Age: 6 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• be between the ages of 5;6 and 12;0 years,
• have a diagnosis of ASD,
• be classified as "minimally verbal" (which is defined as having fewer than 20 spoken words/phrases used for functional communication),
• demonstrate minimal progress in speech acquisition despite having had at least 18 months of speech therapy,
• have no other significant neurological or psychiatric illnesses/disorders other than ASD
• have no major hearing impairment,
• have a nonverbal mental age over 18 months,
• be able to follow 1-step commands without prompting,
• be able to sit in a chair for more than 15 minutes at a time, and
• be able to imitate at least 2 speech sounds on command.
• Families must agree to:
• - attend testing and treatment sessions at BIDMC 5 days/week for approx. 6-8 weeks,
• - attend pre- and post-intervention testing at BU's Autism Center of Excellence,
• - pre- and post-intervention MRI scanning at MGH's Martinos Center, and
• - video-recording of testing and treatment sessions.
• - suspend all other extracurricular speech / language therapies for the duration of the study.

You may not qualify if…

• have a history of significant neurological or psychiatric disorder other than ASD that could interfere with this study as determined by PI;
• have a major hearing impairment,
• have a nonverbal mental age of less than 18 months,
• have undergone a significant amount of intonation-based therapy (more than 25 sessions) within the 12 months period prior to enrollment,
• are able to produce more 20 or more words used communicatively,
• are unable to imitate at least 2 speech sounds on command,
• cannot commit to pre- and post- intervention testing and MRI at BU and MGH,
• cannot commit to 11 weeks of testing and treatment at BIDMC,
• are not willing to be video-recorded.

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Boston University, Autism Center of Excellence — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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