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Music for autism (M4A)
The M4A team met in Vienna in February 2022.
The notion of a connection between autism spectrum disorder (ASD) and music is as old as the first reported cases of autism, and music has been used as a therapeutic tool for many decades. Music therapy (MT) has shown promising results for children's social communication, parent-child relationships, quality of life and participation in family life. However, to predict outcomes more accurately, a better understanding of the working mechanisms, or how MT is leading to positive outcomes, in autistic children is needed.
Therefore, the ongoing Music for Autism (M4A) trial aims to evaluate the effects of 12 weeks of MT compared to 12 weeks of a matched play-based therapy intervention on a group of autistic children ages 6-12 years. The 80 children for the study will be recruited from both Vienna, Austria and Bergen, Norway. Before and after each intervention, children will be assessed for several neurobehavioral and biological outcomes including social communication skills, participation, mental health, brain connectivity, brain structure, gut microbiome, and stress levels. Trial registration page at ClinicalTrials.gov
Project manager and project group
M4A is a binational randomised controlled trial, conducted in Norway and Austria. The researchers leading this project at the three institutions, who have collaborated previously, are:
Christian Gold, PhD, Research Professor at NORCE Norwegian Research Centre AS and Professorial Research Fellow at the University of Vienna, trained in MT, biostatistics, and trial management, with expertise in designing and conducting international multicentre RCTs of MT. His and his group's research has strongly contributed to the increasing evidence base for the effectiveness of MT in mental health. He serves as principal investigator (PI) and will be responsible for overall trial methodology and conduct as well as publication and dissemination. He is supported by existing staff from his team with interdisciplinary expertise (statistics, informatics, MT) to support the conduct of clinical trials. Personal website
Giorgia Silani, PhD, Associate Professor at the Department of Clinical and Health Psychology, Faculty of Psychology, University of Vienna, trained in psychology, clinical and social neuroscience, and psychotherapy. Giorgia Silani has published extensively on ASD in high-ranked journals and will be responsible for acquisition and analysis of fMRI data in Vienna. Personal website
Karsten Specht, PhD, Professor for biological and medical psychology at the University of Bergen, Head of the Bergen fMRI group and PI of a large project on replicability of rsFC, trained in physics and neuroscience, will be responsible for fMRI data acquisition and analysis in Bergen.
Marianna Ruiz, PhD candidate in Bergen, with a background in clinical psychology and neuroimaging, employed at the Health Department of NORCE and registered at the Faculty of Psychology of the University of Bergen. Alexander Groessing, PhD candidate in Vienna, with a background in neuropsychology and music, employed and registered at the Faculty of Psychology of the University of Vienna. Both PhD candidates have the daily responsibility for recruitment, assessment, and intervention in their country.
Maj-Britt Posserud, MD, professor of child and adolescent psychiatry, senior consultant at the autism unit at Haukeland University Hospital, helps with recruitment of participants in Norway. She has performed translational research in ASD and is currently establishing a Translational Research Register for ASD, which will include a pool of 300 potential participants in Western and Eastern Norway.
Isabella Wagner, PhD, assistant professor at the Faculty of Psychology, University of Vienna, is leading the work on the microbiome. Personal website
Alexandrina Guran, PhD, a post-doctoral reseacher at the University of Vienna, and Nace Mikus, a post-doctoral reseacher at the Aarhus University, Denmark, assist in analysing the outcome of behavioural tasks.
Master students in both countries assist with data collection, interventions, and scanning while conducting smaller sub-projects linked to M4A. Therapists and clinical psychologists are working within the project on an hourly basis.
Scientific advisors: Aparna Nadig and Megha Sharda, who conducted the Canadian study, have provided input on methodology and have agreed to act as scientific advisors. This ensures appropriate replication, including fidelity of interventions and reliability of assessments.
User representatives: Jonathan Gärtner, a young man with ASD who participated in MT for many years, and Helene Hodor, his relative who initiated his MT and other supporting activities, serve as user representatives for M4A in Vienna; Kristin Whitehouse, the mother of an autistic child who participated in the study, serves as a user representative in Bergen. Before the project start, user representatives discussed the project; confirmed the relevance of the primary outcome; commented on the importance of secondary outcomes; and gave advice on the relevance of intervention elements. During the project, they continue to give advice to the project team in meetings (ca. 2x/year) and as needed, and also help with recruitment and dissemination through their existing networks.
An independent Data and Safety Monitoring Committee of three people with strong methodological and clinical expertise, who are not otherwise affiliated with the project or its institutions, has been established (Mike Crawford, Paul Bassett, Luise Poustka). The DSMC has unblinded access to study data and will receive regular updates on recruitment, uptake of interventions, unforeseen events, adverse events, and immediate information on serious adverse events from the trial statistician (Jörg Assmus). Meetings with the DSMC are held on a biannual basis and consist of an open and a closed part. If issues arise, the DSMC will recommend to the PI on appropriate action.
Music for autism (M4A)
01.05.21 - 30.04.24