Autism — Testing a Novel Speech Intervention in Minimally Verbal Children With Autism Spectrum Disorder (ASD)
Citation(s)
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.
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. Review.
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.
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.
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. Review.
Wan CY, Schlaug G Neural pathways for language in autism: the potential for music-based treatments. Future Neurol. 2010 Nov;5(6):797-805.
Testing a Novel Speech Intervention in Minimally Verbal Children With Autism Spectrum Disorder (ASD)
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.