About the project

Background

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 aged 6-12 years. The 80 children for the study will be recruited from Vienna, Austria and Bergen, Norway. 

Outcomes

Before and after each intervention, children will be assessed for several neurobehavioral and biological outcomes including social communication skills, participation, family quality of life, mental health, brain connectivity, brain structure, gut microbiome, and stress levels.

For the full list of primary and secondary outcome measures, see the study's trial registration page at ClinicalTrials.gov.

Method

M4A is designed as an assessor blinded crossover RCT, comparing music therapy (MT) to a structurally matched play-based intervention (PBI). Following the baseline assessment, a concealed random allocation to a sequence of interventions (MT-PBI or PBI-MT) will be implemented by one researcher who does not have contact with participants. Each intervention has a duration of 3 months and includes a 3 month washout period between interventions.

Both interventions will consist of 12 weekly one-on-one sessions, 45 minutes each, conducted in the same setting by a licensed music therapist, in accordance with an intervention manual developed for the study. Using a theoretically motivated approach, both interventions will target similar domains such as creating a shared experience, building meaningful relationships, and fostering self-expression. A varied set of activities combining therapist- and child-led interactions will target common goals, such as multisensory integration, verbal and social communication, emotion regulation, turn-taking, social appropriateness, and interaction. During both interventions, children can choose 4 activities per session using a visual schedule to facilitate their choices and as a visual support throughout the therapy. While both therapies will target the same aforementioned goals, music therapy will do so through the use of rhythmic cues, music instruments (e.g., piano, drums, djembe, xylophone, harmonica), songs, and stories accompanied by songs or musical instruments, and the play-based intervention will use verbal interaction, toys (e.g., building bricks, finger puppets, Play-Doh, puzzles), and the same stories as in music therapy, but without a musical component. 

Work packages

WP1: Recruitment and randomisation 
WP2: Clinical assessments and brain imaging 
WP3: Interventions 
WP4: Statistical analyses and reporting 
WP5: Microbiome
WP6: Behavioural tasks

Monitoring Committee

The role of the DSMC is to safeguard the interests of trial participants, assess the safety of the interventions during the trial, and monitor the overall conduct of the clinical trial. The DSMC will monitor data quality, safety, ethical aspects, and that the study can be conducted sufficiently in terms of recruitment, data collection, problems at participating sites, differences between the groups, and missing data.

The independent DSMC consists of three people with strong methodological and clinical expertise who are not otherwise affiliated with the project or its institutions: 

- Mike Crawford (chair; Professor at Imperial College London, UK)
- Luise Poustka (Professor at the University of Göttingen, Germany)
- Paul Bassett (freelance statistician and owner of Statsconsultancy Ltd near London, UK)
- John Carpente (Professor at Molloy University, NY, US)

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.

Advisors

Aparna Nadig and Megha Sharda, who conducted the Canadian study M4A is based upon, 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.

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 (approx. twice a year) and as needed, and also help with recruitment and dissemination through their existing networks.