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

NCT03015272 | Completed Phase 2

• 1 other identifier: 2012P000344
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief 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

Autism

Keywords

minimally-verbal; children; intervention; singing; music

Outcome Measures

Primary Outcomes (1)

• Change in approximately correct Consonant-Vowel Syllables between Best-Baseline and Post-25-session assessment

  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).

  ≥3 Baseline Assessments (over 1 week) after randomization and before therapy initiation; 4 assessments during and after therapy period (after 10, 15, 20, 25 sessions), and one follow-up assessment 4 weeks after the End of Therapy (total period 11 weeks)

Secondary Outcomes (1)

• Change in approximately correct Consonant-Vowel Syllables between Best-Baseline and Post-4-week follow-up assessment

  ≥3 Baseline Assessments (over 1 week) after randomization and before therapy initiation; 4 assessments during and after therapy period (after 10, 15, 20, 25 sessions), and one follow-up assessment 4 weeks after the End of Therapy (total period 11 weeks)

Study Arms (2)

Auditory-Motor Mapping Training (AMMT)

EXPERIMENTAL

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 and 12 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 this intervention.

Behavioral: Auditory-Motor Mapping Training

Speech-Repetition Therapy (SRT)

ACTIVE COMPARATOR

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

Behavioral: Speech-Repetition Therapy

Interventions

Auditory-Motor Mapping Training BEHAVIORAL

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.

Also known as: AMMT

Auditory-Motor Mapping Training (AMMT)

Speech-Repetition Therapy BEHAVIORAL

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.

Also known as: SRT

Speech-Repetition Therapy (SRT)

Eligibility Criteria

• Age: 66 Months - 120 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Boston University: collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Boston University, Autism Center of Excellence

Boston, Massachusetts, 02215, United States

Location

Related Publications (6)

• Wan CY, Bazen L, Baars R, Libenson A, Zipse L, Zuk J, Norton A, Schlaug G. Auditory-motor mapping training as an intervention to facilitate speech output in non-verbal children with autism: a proof of concept study. PLoS One. 2011;6(9):e25505. doi: 10.1371/journal.pone.0025505. Epub 2011 Sep 29.

  PMID: 21980480 BACKGROUND

• Wan CY, Schlaug G. Neural pathways for language in autism: the potential for music-based treatments. Future Neurol. 2010 Nov;5(6):797-805. doi: 10.2217/fnl.10.55.

  PMID: 21197137 BACKGROUND

• Wan CY, Demaine K, Zipse L, Norton A, Schlaug G. From music making to speaking: engaging the mirror neuron system in autism. Brain Res Bull. 2010 May 31;82(3-4):161-8. doi: 10.1016/j.brainresbull.2010.04.010. Epub 2010 Apr 28.

  PMID: 20433906 BACKGROUND

• Kasari C, Brady N, Lord C, Tager-Flusberg H. Assessing the minimally verbal school-aged child with autism spectrum disorder. Autism Res. 2013 Dec;6(6):479-93. doi: 10.1002/aur.1334. Epub 2013 Oct 29.

  PMID: 24353165 BACKGROUND

• Tager-Flusberg H. Promoting communicative speech in minimally verbal children with autism spectrum disorder. J Am Acad Child Adolesc Psychiatry. 2014 Jun;53(6):612-3. doi: 10.1016/j.jaac.2014.04.005. No abstract available.

  PMID: 24839879 BACKGROUND

• Chenausky K, Norton A, Tager-Flusberg H, Schlaug G. Auditory-Motor Mapping Training: Comparing the Effects of a Novel Speech Treatment to a Control Treatment for Minimally Verbal Children with Autism. PLoS One. 2016 Nov 9;11(11):e0164930. doi: 10.1371/journal.pone.0164930. eCollection 2016.

  PMID: 27829034 BACKGROUND

Related Links

• Dr. Schlaug's lab website
• Boston University, Autism Center of Excellence

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Gottfried Schlaug, MD, PhD

  Beth Israel Deaconess Medical Center/Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurology

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: January 10, 2017
• Study Start: November 1, 2014
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share

Locations

US (2)