Testing a Novel Speech Intervention in Minimally Verbal Children With Autism Spectrum Disorder (ASD)
Condition: Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

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.
    

Intervention name(s): Auditory-Motor Mapping Training; Speech-Repetition Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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 intervention name(s): AMMT; SRT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: minimally-verbal; children; intervention; singing; music