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



Status:Recruiting
Conditions:Neurology, Psychiatric, Autism
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:Any
Updated:1/3/2019
Start Date:November 2014
End Date:December 2019
Contact:Gottfried Schlaug, MD, PhD
Email:gschlaug@bidmc.harvard.edu
Phone:617-632-8917

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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.

The ability to communicate verbally is considered the most important prognostic indicator for
children with ASD. If a child has not developed speech by age 5, it is generally considered
unlikely that he or she will do so. Although a small number of cases of speech development in
older children with ASD have been reported, the type and intensity of treatments used varied
widely, suggesting little consensus regarding the likely mechanisms involved. A few
preliminary studies have tested the efficacy of interventions that employed techniques such
as orienting cues, behavioral strategies, and prompts for facilitating speech acquisition in
minimally verbal children, though almost all tested their approaches in children under the
age of 5 who would be classified as preverbal rather than minimally verbal.

Principal Investigator Gottfried Schlaug, MD, PhD oversees all aspects of study treatments
for the interventional arm of this Autism Center of Excellence directed by Helen
Tager-Flusberg of Boston University. The Intervention study's main objective is to compare
the effectiveness of one novel treatment for minimally verbal children with autism spectrum
disorders (ASD), Auditory-Motor Mapping Training (AMMT) to a control intervention termed
Speech Repetition Therapy (SRT), both of which were developed and piloted in Dr. Schlaug's
laboratory. The aim of the present study is to test whether one of those treatments is more
effective than the other in a group of 5;5 to 12;0 year olds.

Participants will be screened and undergo several tests at Boston University's (BU) Autism
Center of Excellence. Those found eligible for the intervention "Testing a novel speech
intervention in minimally verbal children with ASD" will be enrolled and undergo testing at
BU, participate in MRI scanning at Massachusetts General Hospital's (MGH) Martinos Imaging
Center, and will then be randomly assigned to either the AMMT or SRT group for treatment at
BIDMC. Before the intervention begins, participants will have up to 5 Baseline testing
sessions (approx. 45-60 min./session) to (1) determine their ability to repeat a set of
high-frequency 2-syllable words/phrases (e.g., Hello and All done), and (2) obtain an
inventory of speech sounds that they are able to produce prior to treatment.

The intervention consists of 25 one-on-one therapy sessions during which children will be
working toward producing (or approximating) a set of high-frequency 2-syllable words/phrases
(e.g., "More, please", "Mommy", "All done", etc.). Progress will be monitored several times
during the treatment phase as well as immediately after the 25 sessions and 4-weeks later.
The total time commitment for the Intervention portion of the study will be approximately 6-8
weeks (i.e., approx. 1 week (±) for Baseline testing; approx. 5 weeks (5 sessions/week) for
treatment; and approx. 1 week (±) for several mid- and post-treatment testing sessions). Upon
completion of the intervention at BIDMC, participants will undergo post-treatment testing at
BU and follow-up MRI at MGH's Martinos Imaging Center.

Results of this study will not only help determine if one of the two interventions is
effective by comparing post-treatment assessments to baseline assessments but will also
compare the experimental treatment (AMMT) versus the control treatment (SRT) to examine
whether or not one is more effective than the other.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
2
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Phone: 617-632-8926
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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