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

Autism Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

• NCT number: NCT03015272
• Study type: Interventional
• Source: Beth Israel Deaconess Medical Center
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 2014
• Completion date: December 2019