<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03015272</url>
  </required_header>
  <id_info>
    <org_study_id>2012P000344</org_study_id>
    <nct_id>NCT03015272</nct_id>
  </id_info>
  <brief_title>Testing a Novel Speech Intervention in Minimally Verbal Children With Autism Spectrum Disorder (ASD)</brief_title>
  <official_title>Testing a Novel Speech Intervention in Minimally Verbal Children With Autism Spectrum Disorder (ASD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beth Israel Deaconess Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beth Israel Deaconess Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the Novel Language Intervention for minimally verbal children with Autism&#xD;
      Spectrum Disorder (ASD) is to test the efficacy of one experimental treatment (AMMT) compared&#xD;
      to baseline assessments and compare the AMMT efficacy to a control intervention (SRT), both&#xD;
      treatments were designed to facilitate speech output in minimally verbal 5.5 to 12.0 year&#xD;
      olds. This study aims to compare the two interventions (one intonation-based; the other&#xD;
      non-intonation-based) in a single-blind, randomized controlled trial (RCT) that includes a&#xD;
      comprehensive baseline assessment battery, 25 intensive 1-on-1 treatment sessions conducted 5&#xD;
      days/week, and a series of probe assessments administered at multiple timepoints pre-,&#xD;
      during, and post-therapy.&#xD;
&#xD;
      Despite the complex needs of minimally verbal children with ASD and the wide variety of&#xD;
      treatments available to address many of those needs, there is still a great need for&#xD;
      effective methods that promote the development of speech sounds and facilitate the production&#xD;
      of those sounds in this growing population. While the primary aim of this RCT is to&#xD;
      investigate the effects of AMMTversus a control intervention (SRT) on minimally verbal&#xD;
      children with ASD and compare the two interventions to determine whether one is more&#xD;
      effective than the other, this study also aims to examine whether baseline cognitive skills,&#xD;
      speech praxis, joint attention abilities and/or neural architecture can predict the effects&#xD;
      of treatment with AMMT or SRT in minimally verbal children with ASD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ability to communicate verbally is considered the most important prognostic indicator for&#xD;
      children with ASD. If a child has not developed speech by age 5, it is generally considered&#xD;
      unlikely that he or she will do so. Although a small number of cases of speech development in&#xD;
      older children with ASD have been reported, the type and intensity of treatments used varied&#xD;
      widely, suggesting little consensus regarding the likely mechanisms involved. A few&#xD;
      preliminary studies have tested the efficacy of interventions that employed techniques such&#xD;
      as orienting cues, behavioral strategies, and prompts for facilitating speech acquisition in&#xD;
      minimally verbal children, though almost all tested their approaches in children under the&#xD;
      age of 5 who would be classified as preverbal rather than minimally verbal.&#xD;
&#xD;
      Principal Investigator Gottfried Schlaug, MD, PhD oversees all aspects of study treatments&#xD;
      for the interventional arm of this Autism Center of Excellence directed by Helen&#xD;
      Tager-Flusberg of Boston University. The Intervention study's main objective is to compare&#xD;
      the effectiveness of one novel treatment for minimally verbal children with autism spectrum&#xD;
      disorders (ASD), Auditory-Motor Mapping Training (AMMT) to a control intervention termed&#xD;
      Speech Repetition Therapy (SRT), both of which were developed and piloted in Dr. Schlaug's&#xD;
      laboratory. The aim of the present study is to test whether one of those treatments is more&#xD;
      effective than the other in a group of 5;5 to 12;0 year olds.&#xD;
&#xD;
      Participants will be screened and undergo several tests at Boston University's (BU) Autism&#xD;
      Center of Excellence. Those found eligible for the intervention &quot;Testing a novel speech&#xD;
      intervention in minimally verbal children with ASD&quot; will be enrolled and undergo testing at&#xD;
      BU, participate in MRI scanning at Massachusetts General Hospital's (MGH) Martinos Imaging&#xD;
      Center, and will then be randomly assigned to either the AMMT or SRT group for treatment at&#xD;
      BIDMC. Before the intervention begins, participants will have up to 5 Baseline testing&#xD;
      sessions (approx. 45-60 min./session) to (1) determine their ability to repeat a set of&#xD;
      high-frequency 2-syllable words/phrases (e.g., Hello and All done), and (2) obtain an&#xD;
      inventory of speech sounds that they are able to produce prior to treatment.&#xD;
&#xD;
      The intervention consists of 25 one-on-one therapy sessions during which children will be&#xD;
      working toward producing (or approximating) a set of high-frequency 2-syllable words/phrases&#xD;
      (e.g., &quot;More, please&quot;, &quot;Mommy&quot;, &quot;All done&quot;, etc.). Progress will be monitored several times&#xD;
      during the treatment phase as well as immediately after the 25 sessions and 4-weeks later.&#xD;
      The total time commitment for the Intervention portion of the study will be approximately 6-8&#xD;
      weeks (i.e., approx. 1 week (±) for Baseline testing; approx. 5 weeks (5 sessions/week) for&#xD;
      treatment; and approx. 1 week (±) for several mid- and post-treatment testing sessions). Upon&#xD;
      completion of the intervention at BIDMC, participants will undergo post-treatment testing at&#xD;
      BU and follow-up MRI at MGH's Martinos Imaging Center.&#xD;
&#xD;
      Results of this study will not only help determine if one of the two interventions is&#xD;
      effective by comparing post-treatment assessments to baseline assessments but will also&#xD;
      compare the experimental treatment (AMMT) versus the control treatment (SRT) to examine&#xD;
      whether or not one is more effective than the other.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">September 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in approximately correct Consonant-Vowel Syllables between Best-Baseline and Post-25-session assessment</measure>
    <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)</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in approximately correct Consonant-Vowel Syllables between Best-Baseline and Post-4-week follow-up assessment</measure>
    <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)</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Autism</condition>
  <arm_group>
    <arm_group_label>Auditory-Motor Mapping Training (AMMT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Speech-Repetition Therapy (SRT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Auditory-Motor Mapping Training</intervention_name>
    <description>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.</description>
    <arm_group_label>Auditory-Motor Mapping Training (AMMT)</arm_group_label>
    <other_name>AMMT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Speech-Repetition Therapy</intervention_name>
    <description>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.</description>
    <arm_group_label>Speech-Repetition Therapy (SRT)</arm_group_label>
    <other_name>SRT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be between the ages of 5;6 and 12;0 years,&#xD;
&#xD;
          -  have a diagnosis of ASD,&#xD;
&#xD;
          -  be classified as &quot;minimally verbal&quot; (which is defined as having fewer than 20 spoken&#xD;
             words/phrases used for functional communication),&#xD;
&#xD;
          -  demonstrate minimal progress in speech acquisition despite having had at least 18&#xD;
             months of speech therapy,&#xD;
&#xD;
          -  have no other significant neurological or psychiatric illnesses/disorders other than&#xD;
             ASD&#xD;
&#xD;
          -  have no major hearing impairment,&#xD;
&#xD;
          -  have a nonverbal mental age over 18 months,&#xD;
&#xD;
          -  be able to follow 1-step commands without prompting,&#xD;
&#xD;
          -  be able to sit in a chair for more than 15 minutes at a time, and&#xD;
&#xD;
          -  be able to imitate at least 2 speech sounds on command.&#xD;
&#xD;
          -  Families must agree to:&#xD;
&#xD;
          -  - attend testing and treatment sessions at BIDMC 5 days/week for approx. 6-8 weeks,&#xD;
&#xD;
          -  - attend pre- and post-intervention testing at BU's Autism Center of Excellence,&#xD;
&#xD;
          -  - pre- and post-intervention MRI scanning at MGH's Martinos Center, and&#xD;
&#xD;
          -  - video-recording of testing and treatment sessions.&#xD;
&#xD;
          -  - suspend all other extracurricular speech / language therapies for the duration of&#xD;
             the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have a history of significant neurological or psychiatric disorder other than ASD that&#xD;
             could interfere with this study as determined by PI;&#xD;
&#xD;
          -  have a major hearing impairment,&#xD;
&#xD;
          -  have a nonverbal mental age of less than 18 months,&#xD;
&#xD;
          -  have undergone a significant amount of intonation-based therapy (more than 25&#xD;
             sessions) within the 12 months period prior to enrollment,&#xD;
&#xD;
          -  are able to produce more 20 or more words used communicatively,&#xD;
&#xD;
          -  are unable to imitate at least 2 speech sounds on command,&#xD;
&#xD;
          -  cannot commit to pre- and post- intervention testing and MRI at BU and MGH,&#xD;
&#xD;
          -  cannot commit to 11 weeks of testing and treatment at BIDMC,&#xD;
&#xD;
          -  are not willing to be video-recorded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>66 Months</minimum_age>
    <maximum_age>120 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gottfried Schlaug, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center/Harvard Medical School</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston University, Autism Center of Excellence</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.musicianbrain.com</url>
    <description>Dr. Schlaug's lab website</description>
  </link>
  <link>
    <url>http://www.bu.edu/autism/current-research/autism-center-of-excellence/novel-language-intervention/</url>
    <description>Boston University, Autism Center of Excellence</description>
  </link>
  <reference>
    <citation>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.</citation>
    <PMID>21980480</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21197137</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20433906</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24353165</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24839879</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27829034</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 29, 2016</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>May 15, 2020</last_update_submitted>
  <last_update_submitted_qc>May 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beth Israel Deaconess Medical Center</investigator_affiliation>
    <investigator_full_name>Gottfried Schlaug</investigator_full_name>
    <investigator_title>Associate Professor of Neurology</investigator_title>
  </responsible_party>
  <keyword>minimally-verbal</keyword>
  <keyword>children</keyword>
  <keyword>intervention</keyword>
  <keyword>singing</keyword>
  <keyword>music</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03015272
org study id: 2012P000344
nct id: NCT03015272
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: 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)
description: 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).
measure: 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)
description: 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).
arm group label: Auditory-Motor Mapping Training (AMMT)
arm group type: Experimental
description: 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.
arm group label: Speech-Repetition Therapy (SRT)
arm group type: Active Comparator
description: 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
intervention type: Behavioral
intervention name: Auditory-Motor Mapping Training
description: 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.
arm group label: Auditory-Motor Mapping Training (AMMT)
other name: AMMT
intervention type: Behavioral
intervention name: Speech-Repetition Therapy
description: 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.
arm group label: Speech-Repetition Therapy (SRT)
other name: SRT
criteria: 
gender: All
minimum age: 66 Months
maximum age: 120 Months
healthy volunteers: No
last name: Gottfried Schlaug, MD, PhD
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center/Harvard Medical School
facility: 
facility: 
country: United States
url: http://www.musicianbrain.com
description: Dr. Schlaug's lab website
url: http://www.bu.edu/autism/current-research/autism-center-of-excellence/novel-language-intervention/
description: Boston University, Autism Center of Excellence
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
responsible party type: Principal Investigator
investigator affiliation: Beth Israel Deaconess Medical Center
investigator full name: Gottfried Schlaug
investigator title: Associate Professor of Neurology
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
sharing ipd: Yes