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

May 15, 2020 updated by: Gottfried Schlaug, Beth Israel Deaconess Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • Boston University, Autism Center of Excellence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Auditory-Motor Mapping Training (AMMT)
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
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.
Other Names:
  • AMMT
Active Comparator: Speech-Repetition Therapy (SRT)
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
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.
Other Names:
  • SRT

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in approximately correct Consonant-Vowel Syllables between Best-Baseline and Post-25-session assessment
Time Frame: ≥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)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in approximately correct Consonant-Vowel Syllables between Best-Baseline and Post-4-week follow-up assessment
Time Frame: ≥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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beth Israel Deaconess Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gottfried Schlaug, MD, PhD, Beth Israel Deaconess Medical Center/Harvard Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012P000344

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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