MusT-In Therapy (Effect of Music Therapy and Interaction with Typically Developing Peers) for improving social interaction in children with severe autism spectrum disorder - Study protocol.

Abstract

Background: Autism Spectrum Disorder (ASD) affects 1 out of every 54 children in the United States, impairing their social skills and independence. Current evidence from clinical trials and meta-analyses suggests that, individually, both music therapy and interaction with typically developing peers (TD) can improve social skills in children with ASD. However, there are no clearly defined parameters for the combined efficacy of these interventions and their long-term effects. Therefore, conducting new studies in this area is of utmost importance not only for the scientific community but also for children with ASD and their caregivers. Objective: To evaluate the effect of a new add-on therapy on improving social interaction skills in children with severe ASD –the MusT-In Therapy– which combines music therapy and interaction with TD peers.

Methods: This is a phase II single-center, two-arm, parallel-group, randomized 1:1, assessor-blinded trial. 116 children with severe ASD (3-6 years old) will be assigned to either the standard of care or 30 weekly sessions of the MusT-In therapy plus standard of care. Improvement in social interaction will be assessed after 30 therapy sessions with the Vineland Scale 3rd edition as the primary outcome. Follow-up assessment of the outcome will be at 1 and 3 months after the intervention has finished.

Discussion: Given the lack of robust evidence-based therapies for ASD, the development of new treatments is paramount. Children with severe ASD have been underrepresented in previous trials and parental burden increases with the severity of the spectrum. If our intervention proves to be effective it could be the basis of a new treatment option.