AutismCHIMENCT06016621
Autism - Children's Improvisational Music Therapy Evaluation
A study testing Improvisational Music Therapy in people with Autism, run by Prof Simon Baron-Cohen at 2 sites in United Kingdom.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of individual sessions of improvisational music therapy for autistic children aged 7 - 11. Researchers will compare the impact of adding improvisational music therapy to usual care alone for autistic children over a 12-week period. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Autism
- What is being tested?
- Improvisational Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 13 Nov 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 7 to 11 years.
- A clinical diagnosis of autism made by a qualified professional according to the International Classification of Diseases (ICD) 10th Revision criteria. Confirmed by a copy of the clinical report detailing the diagnosis (if available) or verified verbally by the child's parents.
- Parents/guardians must give informed consent for their children to be enrolled in the trial.
- Parents/guardians must be willing for the music therapy sessions and BOSCC assessments to be video recorded for monitoring and research purpose
- Participants must be willing to attend two music therapy sessions per week for the duration of the trial.
- Non-verbal children may be included
Who cannot join
- Received regular individual music therapy in the preceding year as this would be likely to have a strong influence on the course of therapy.
- Severe hearing deficit as this would alter the aim, course, and implementation of therapy.
- Caregivers that are unable to attend for the psychological assessments with their child.
- Caregivers without a basic understanding of English.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Artur Jaschke, PhD contact
United Kingdom2 sites, 2 recruiting
- Recruiting
Anglia Ruskin University
Cambridge, CB1 1PT
Jonathan Pool, PhD
- Recruiting
Autism Research Centre
Cambridge, CB2 8AH
Artur Jaschke, PhD
About this study
Official title: A Randomised Controlled Trial on the Effectiveness of Improvisational Music Therapy for Autistic Children Aged 7 - 11 [Autism-CHIME Trial].
The goal of this clinical trial is to evaluate the effectiveness of individual sessions of improvisational music therapy for autistic children aged 7 - 11.
Researchers will compare the impact of adding improvisational music therapy to usual care alone for autistic children over a 12-week period.
Read more
Participants will be randomly assigned to one of the following two conditions: the Improvisational Music Therapy (intervention) Group or the support as usual (control) Group.
The aim is to achieve seven overarching objectives:
- To determine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving social communication in autistic children.
- To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving communication skills in autistic children.
- To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in reducing psychosocial problems in autistic children.
- To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving wellbeing of autistic children.
- To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving adaptive functioning in autistic children.
- To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving anxiety in autistic children.
- To examine whether the therapeutic relationship predicts the development of social, communication and language skills among autistic children.
Read the detailed description
Co-Chief Investigators Professor Simon Baron-Cohen Dr Carrie Allison Dr David M. Greenberg Dr. Jonathan Pool
Co-Investigators Dr Artur Jaschke
Advisor Emeritus Professor Helen Odell-Miller Dr. Claire Howlin
The Autism-CHIME trial is designed as a rigorous Randomised Controlled Trial (RCT) of individual sessions of improvisational music therapy with autistic children. The trial will be conducted in mainstream and special schools located in Cambridgeshire, Peterborough, London, and the South and East of England. The number of schools involved will depend on the number of eligible children willing to participate, with a minimum of 5-10 children per school.
Enrolled participants will undergo 1:1 block randomisation, to either support as usual plus improvisational music therapy sessions (intervention arm) or support as usual (control arm). Randomisation will occur after the baseline assessments have been completed. Participants will be stratified based on the version of the Brief Observation of Social Communication Change (BOSCC) that they are allocated (primary outcome measure): (1) Minimally Verbal, (2) Phrase Speakers, or (3) Fluent Speakers, so that there are equal numbers in each group, and that the control group and experimental group are balanced.
Data will be collected at different time points during the trial:
The first data collection point (T1) will be collected prior to randomisation (to establish eligibility to participate and assess baseline functioning), and at the primary endpoint T2 (13 weeks after randomisation; end of intervention) and the secondary endpoint T3 will be 39 weeks post-randomisation (i.e. 6 months after the end of music therapy).
The trial will finish after the final follow-up data collection from the participants is completed.
- Conditions
- Autism
- Being tested
- Improvisational Music Therapy
- Keywords
- Randomised Controlled Trial, Improvisational music therapy, Autism, Children, Social communication, Social cognition
- Medical subject headings
- Autistic Disorder, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improvisational Music TherapyBehavioural
The therapist engages with the child by playing and sharing musical instruments, and/or sings while being attuned to the child's behaviour and expression. Various improvisational techniques are employed to engage the child. There are opportunities for pulse, rhythmic, dynamic or melodic patterns, and timbre to be mirrored, reinforced, or complemented, which allows for moments of synchronization between the therapist and the child, giving the child's musical expressions a pragmatic meaning within this context. The therapist may also gently provoke the child by violating expectations or patterns that have been jointly developed in order to elicit specific social communication behaviours. Further, there are opportunities for the child to develop and enhance social communication skills such as joint attention, sharing affect, reciprocity, shared history, scaffolding, imitation and turn-taking. These have been shown to develop social competency and also resilience.
| Study group | Role | What they receive |
|---|---|---|
| Support as usual control Group | No intervention | Participants allocated to 'support as usual' will receive routine support from their general practitioners (GPs), mental health and education/allied health professionals. Support as usual is defined as normal practice for each school in addition to the usual support from the specialist teaching teams for autism in the area, or any other additional therapies intended to support communication skills or wellbeing for autistic children. They will not receive the individual music therapy intervention or any extra support services from the research team. Any concomitant treatment or therapeutic interventions that participating children might receive will be recorded during assessment sessions before randomisation, and following the primary endpoint, specifying the kind and amount or frequency of intervention. |
| Improvisational Music Therapy | Experimental | Participating children randomised to the Improvisational Music Therapy (intervention) Group will receive 30-minute individual music therapy sessions two times per week over a 12-week period. These will be delivered by academically trained Health and Care Professions Council (HCPC)-registered music therapists in the United Kingdom (master's level or equivalent) with clinical experience of working with autistic children. Each child in the intervention arm will receive 24 sessions of music therapy over a 12-week period. A music therapy training manual will be used to guide music therapists. Receives: Behavioral: Improvisational Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change of the total score of the Brief Observation of Social Communication Change (BOSCC). One of three versions of the BOSCC will be used depending on the child's level of verbal communication.
The BOSCC consists of specific items that were developed to identify changes in social-communication behaviours over relatively short periods of time by quantifying subtleties in both the frequency and the quality of specific behaviours. There are three forms of the BOSCC: one for individuals who are minimally verbal (MV), one for those with phrase speech/young fluent speakers (PS/YF up to age 6 - 8) and one for fluent speakers (F1/F2 with two sets of materials, one for children and one for adolescents and adults). Scores are based on the observation of social communicative behaviour during naturalistic interactions between a child and an adult.
Measured: Baseline and at the end of intervention (13 weeks after randomisation).
Secondary outcomes (8)
Absolute change of the total score of the BOSCC.
The BOSCC consists of specific items that were developed to identify changes in social-communication behaviours.
Measured: Baseline and 39 weeks after randomisation.
Absolute change of the total score of the Children's Communication Checklist-2 to test improvement in communication skills.
Measure designed to assess the communication skills of children 4 to 16. It includes two domains: Language (Speech, Syntax, Semantics, Coherence) and Pragmatics (Initiation, Scripted Language, Context, Nonverbal Communication, Social Relations, Interests).
Measured: Baseline, 13 and 39 weeks after randomisation.
Absolute change of the total score of the Strengths and Difficulties Questionnaire to test improvement in psychosocial difficulties
Questionnaire of behavioural and emotional difficulties suitable for children aged 3-16 years old. It addresses different dimensions: emotional problems, conduct problems, hyperactivity/inattention problems, peer problems and prosocial behaviour.
Measured: Baseline, 13 and 39 weeks after randomisation.
Absolute change of the total score of the Young Child Outcome Rating Scale (YCORS) as a measure of wellbeing.
Engaging young children regarding their assessment of how they are doing using child friendly language (faces).
Measured: Baseline, 13 and 39 weeks after randomisation.
Absolute change of the total score of the Vineland-3 Domain level parent/caregiver form to test improvement in adaptive functioning.
Measure of adaptive functioning including Communication domain, Daily living skills domain and Socialization domain.
Measured: Baseline, 13 and 39 weeks after randomisation.
Absolute change of the total score of the Parent-Rated Anxiety Scale (PRAS) for Youth with Autism Spectrum Disorder (ASD) as a measure of anxiety.
The PRAS-ASD is a 25-item, parent-reported measure of anxiety symptoms in youth with ASD (age 5-17 years).
Measured: Baseline, 13 and 39 weeks after randomisation.
Association between the therapeutic relationship and the development of social, communication and language skills.
The therapeutic relationship will be measured using the Assessment of the Quality of Relationship (AQR), based on video recordings of the first and last of music therapy to evaluate the association between the therapeutic relationship and the development of social, communication and language skills in children allocated to the music therapy intervention.
Measured: Weeks 1 and 12
Absolute change of the total score of the Music Therapy Communication and Social Interaction Scale (MTCSI) (or Music Engagement Scale, MES) based on video recordings.
Measured based on video recordings of the first and last weeks of music therapy in all of the children allocated to the music therapy intervention) to evaluate communicative and socially interactive responses that are elicited during music therapy sessions.
Measured: Weeks 1 and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start13 Nov 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assessor-blind, multi-centre, pragmatic, two-arm, randomised controlled trial in which participants will be randomly allocated to either: 1. Twice-weekly 30 minute-sessions of one to one improvisational music therapy over 12 weeks, in addition to support as usual. 2. Support as usual control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof Simon Baron-Cohen
- Sponsor type
- University, hospital or other
- Collaborators
- Anglia Ruskin University, Musical Universe, Rosetrees Trust, Stoneygate Trust, Autism Centre of Excellence
- Responsible party
- Sponsor-investigator, Prof Simon Baron-Cohen, University of Cambridge
- Investigators
- Jonathan Pool, PhD, Principal investigator, Cambridge Institute for Music Therapy Research. Anglia Ruskin University, CambridgeDavid M. David M. Greenberg, PhD, Principal investigator, Musical Universe Inc. USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016621
- Sponsor's protocol ID
- PRE.2022.077
- Other IDs
- ETH2223-3184
- Acronym
- CHIME
- Status last verified
- Mar 2025
- First submitted
- 19 Aug 2023
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Levitin, D. J. This is your brain on music: The science of a human obsession. vi, 314 (Dutton/Penguin Books, 2006).
Savage PE, Loui P, Tarr B, Schachner A, Glowacki L, Mithen S, Fitch WT. Music as a coevolved system for social bonding. Behav Brain Sci. 2020 Aug 20;44:e59. doi: 10.1017/S0140525X20000333.
PubMed 32814608Sharda M, Tuerk C, Chowdhury R, Jamey K, Foster N, Custo-Blanch M, Tan M, Nadig A, Hyde K. Music improves social communication and auditory-motor connectivity in children with autism. Transl Psychiatry. 2018 Oct 23;8(1):231. doi: 10.1038/s41398-018-0287-3.
PubMed 30352997American Music Therapy Association (AMTA). https://www.musictherapy.org/.
Diagnostic and statistical manual of mental disorders: DSM-5TM, 5th ed. xliv, 947 (American Psychiatric Publishing, Inc., 2013). doi:10.1176/appi.books.9780890425596.
Kanner L. Autistic disturbances of affective contact. Acta Paedopsychiatr. 1968;35(4):100-36. No abstract available.
PubMed 4880460Stegemann T, Geretsegger M, Phan Quoc E, Riedl H, Smetana M. Music Therapy and Other Music-Based Interventions in Pediatric Health Care: An Overview. Medicines (Basel). 2019 Feb 14;6(1):25. doi: 10.3390/medicines6010025.
PubMed 30769834Lim HA, Draper E. The effects of music therapy incorporated with applied behavior analysis verbal behavior approach for children with autism spectrum disorders. J Music Ther. 2011 Winter;48(4):532-50. doi: 10.1093/jmt/48.4.532.
PubMed 22506303Lim HA. Effect of "developmental speech and language training through music" on speech production in children with autism spectrum disorders. J Music Ther. 2010 Spring;47(1):2-26. doi: 10.1093/jmt/47.1.2.
PubMed 20635521Carpente, J. A. Investigating the Effectiveness of a Developmental, Individual Difference, Relationship-Based (DIR) Improvisational Music Therapy Program on Social Communication for Children with Autism Spectrum Disorder. Music Therapy Perspectives 35, 160-174 (2017).
Thompson GA, McFerran KS, Gold C. Family-centred music therapy to promote social engagement in young children with severe autism spectrum disorder: a randomized controlled study. Child Care Health Dev. 2014 Nov;40(6):840-52. doi: 10.1111/cch.12121. Epub 2013 Nov 22.
PubMed 24261547Walworth DD. The use of music therapy within the SCERTS model for children with Autism Spectrum Disorder. J Music Ther. 2007 Spring;44(1):2-22. doi: 10.1093/jmt/44.1.2.
PubMed 17419661Walworth DD, Register D, Engel JN. Using the SCERTS model assessment tool to identify music therapy goals for clients with autism spectrum disorder. J Music Ther. 2009 Fall;46(3):204-16. doi: 10.1093/jmt/46.3.204.
PubMed 19757876LaGasse AB. Effects of a music therapy group intervention on enhancing social skills in children with autism. J Music Ther. 2014 Fall;51(3):250-75. doi: 10.1093/jmt/thu012. Epub 2014 Jul 22.
PubMed 25053766Kim J, Wigram T, Gold C. The effects of improvisational music therapy on joint attention behaviors in autistic children: a randomized controlled study. J Autism Dev Disord. 2008 Oct;38(9):1758-66. doi: 10.1007/s10803-008-0566-6. Epub 2008 Jul 1.
PubMed 18592368
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial on the Effectiveness of Improvisational Music Therapy for Autistic Children Aged 7 - 11 [Autism-CHIME Trial].
- ClinicalTrials.gov ID
- NCT06016621
- Acronym / sponsor ID
- CHIME / PRE.2022.077
- Conditions
- Autism
- Keywords
- Randomised Controlled Trial, Improvisational music therapy, Autism, Children, Social communication, Social cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Prof Simon Baron-CohenUniversity, hospital or other
- Collaborators
- Anglia Ruskin University, Musical Universe, Rosetrees Trust, Stoneygate Trust, Autism Centre of Excellence
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the effectiveness of individual sessions of improvisational music therapy for autistic children aged 7 - 11.
Researchers will compare the impact of adding improvisational music therapy to usual care alone for autistic children over a 12-week period.
Participants will be randomly assigned to one of the following two conditions: the Improvisational Music Therapy (intervention) Group or the support as usual (control) Group.
The aim is to achieve seven overarching objectives:
- To determine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving social communication in autistic children.
- To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving communication skills in autistic children.
- To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in reducing psychosocial problems in autistic children.
- To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving wellbeing of autistic children.
- To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving adaptive functioning in autistic children.
- To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving anxiety in autistic children.
- To examine whether the therapeutic relationship predicts the development of social, communication and language skills among autistic children.
Detailed description
Co-Chief Investigators Professor Simon Baron-Cohen Dr Carrie Allison Dr David M. Greenberg Dr. Jonathan Pool
Co-Investigators Dr Artur Jaschke
Advisor Emeritus Professor Helen Odell-Miller Dr. Claire Howlin
The Autism-CHIME trial is designed as a rigorous Randomised Controlled Trial (RCT) of individual sessions of improvisational music therapy with autistic children. The trial will be conducted in mainstream and special schools located in Cambridgeshire, Peterborough, London, and the South and East of England. The number of schools involved will depend on the number of eligible children willing to participate, with a minimum of 5-10 children per school.
Enrolled participants will undergo 1:1 block randomisation, to either support as usual plus improvisational music therapy sessions (intervention arm) or support as usual (control arm). Randomisation will occur after the baseline assessments have been completed. Participants will be stratified based on the version of the Brief Observation of Social Communication Change (BOSCC) that they are allocated (primary outcome measure): (1) Minimally Verbal, (2) Phrase Speakers, or (3) Fluent Speakers, so that there are equal numbers in each group, and that the control group and experimental group are balanced.
Data will be collected at different time points during the trial:
The first data collection point (T1) will be collected prior to randomisation (to establish eligibility to participate and assess baseline functioning), and at the primary endpoint T2 (13 weeks after randomisation; end of intervention) and the secondary endpoint T3 will be 39 weeks post-randomisation (i.e. 6 months after the end of music therapy).
The trial will finish after the final follow-up data collection from the participants is completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Assessor-blind, multi-centre, pragmatic, two-arm, randomised controlled trial in which participants will be randomly allocated to either: 1. Twice-weekly 30 minute-sessions of one to one improvisational music therapy over 12 weeks, in addition to support as usual. 2. Support as usual control group.
| Arm | Type | Receives |
|---|---|---|
| Support as usual control Group | No intervention | –Participants allocated to 'support as usual' will receive routine support from their general practitioners (GPs), mental health and education/allied health professionals. Support as usual is defined as normal practice for each school in addition to the usual support from the specialist teaching teams for autism in the area, or any other additional therapies intended to support communication skills or wellbeing for autistic children. They will not receive the individual music therapy intervention or any extra support services from the research team. Any concomitant treatment or therapeutic interventions that participating children might receive will be recorded during assessment sessions before randomisation, and following the primary endpoint, specifying the kind and amount or frequency of intervention. |
| Improvisational Music Therapy | Experimental | Behavioral: Improvisational Music TherapyParticipating children randomised to the Improvisational Music Therapy (intervention) Group will receive 30-minute individual music therapy sessions two times per week over a 12-week period. These will be delivered by academically trained Health and Care Professions Council (HCPC)-registered music therapists in the United Kingdom (master's level or equivalent) with clinical experience of working with autistic children. Each child in the intervention arm will receive 24 sessions of music therapy over a 12-week period. A music therapy training manual will be used to guide music therapists. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged 7 to 11 years.
- A clinical diagnosis of autism made by a qualified professional according to the International Classification of Diseases (ICD) 10th Revision criteria. Confirmed by a copy of the clinical report detailing the diagnosis (if available) or verified verbally by the child's parents.
- Parents/guardians must give informed consent for their children to be enrolled in the trial.
- Parents/guardians must be willing for the music therapy sessions and BOSCC assessments to be video recorded for monitoring and research purpose
- Participants must be willing to attend two music therapy sessions per week for the duration of the trial.
Key exclusion criteria (4 listed)
- Received regular individual music therapy in the preceding year as this would be likely to have a strong influence on the course of therapy.
- Severe hearing deficit as this would alter the aim, course, and implementation of therapy.
- Caregivers that are unable to attend for the psychological assessments with their child.
- Caregivers without a basic understanding of English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improvisational Music TherapyThe therapist engages with the child by playing and sharing musical instruments, and/or sings while being attuned to the child's behaviour and expression. Various improvisational techniques are employed to engage the child. There are opportunities for pulse, rhythmic, dynamic or melodic patterns, and timbre to be mirrored, reinforced, or complemented, which allows for moments of synchronization between the therapist and the child, giving the child's musical expressions a pragmatic meaning within this context. The therapist may also gently provoke the child by violating expectations or patterns that have been jointly developed in order to elicit specific social communication behaviours. Further, there are opportunities for the child to develop and enhance social communication skills such as joint attention, sharing affect, reciprocity, shared history, scaffolding, imitation and turn-taking. These have been shown to develop social competency and also resilience. | Behavioural | Improvisational Music Therapy |
Primary outcome
Absolute change of the total score of the Brief Observation of Social Communication Change (BOSCC). One of three versions of the BOSCC will be used depending on the child's level of verbal communication.
Time frame: Baseline and at the end of intervention (13 weeks after randomisation).
The BOSCC consists of specific items that were developed to identify changes in social-communication behaviours over relatively short periods of time by quantifying subtleties in both the frequency and the quality of specific behaviours. There are three forms of the BOSCC: one for individuals who are minimally verbal (MV), one for those with phrase speech/young fluent speakers (PS/YF up to age 6 - 8) and one for fluent speakers (F1/F2 with two sets of materials, one for children and one for adolescents and adults). Scores are based on the observation of social communicative behaviour during naturalistic interactions between a child and an adult.
8 secondary outcomes
Absolute change of the total score of the BOSCC.
Time frame: Baseline and 39 weeks after randomisation.
Absolute change of the total score of the Children's Communication Checklist-2 to test improvement in communication skills.
Time frame: Baseline, 13 and 39 weeks after randomisation.
Absolute change of the total score of the Strengths and Difficulties Questionnaire to test improvement in psychosocial difficulties
Time frame: Baseline, 13 and 39 weeks after randomisation.
Absolute change of the total score of the Young Child Outcome Rating Scale (YCORS) as a measure of wellbeing.
Time frame: Baseline, 13 and 39 weeks after randomisation.
Absolute change of the total score of the Vineland-3 Domain level parent/caregiver form to test improvement in adaptive functioning.
Time frame: Baseline, 13 and 39 weeks after randomisation.
Absolute change of the total score of the Parent-Rated Anxiety Scale (PRAS) for Youth with Autism Spectrum Disorder (ASD) as a measure of anxiety.
Time frame: Baseline, 13 and 39 weeks after randomisation.
Association between the therapeutic relationship and the development of social, communication and language skills.
Time frame: Weeks 1 and 12
Absolute change of the total score of the Music Therapy Communication and Social Interaction Scale (MTCSI) (or Music Engagement Scale, MES) based on video recordings.
Time frame: Weeks 1 and 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- BackgroundLevitin, D. J. This is your brain on music: The science of a human obsession. vi, 314 (Dutton/Penguin Books, 2006).
- Background: PubMed 32814608Savage PE, Loui P, Tarr B, Schachner A, Glowacki L, Mithen S, Fitch WT. Music as a coevolved system for social bonding. Behav Brain Sci. 2020 Aug 20;44:e59. doi: 10.1017/S0140525X20000333.
- Background: PubMed 30352997Sharda M, Tuerk C, Chowdhury R, Jamey K, Foster N, Custo-Blanch M, Tan M, Nadig A, Hyde K. Music improves social communication and auditory-motor connectivity in children with autism. Transl Psychiatry. 2018 Oct 23;8(1):231. doi: 10.1038/s41398-018-0287-3.
- BackgroundAmerican Music Therapy Association (AMTA). https://www.musictherapy.org/.
- BackgroundDiagnostic and statistical manual of mental disorders: DSM-5TM, 5th ed. xliv, 947 (American Psychiatric Publishing, Inc., 2013). doi:10.1176/appi.books.9780890425596.
- Background: PubMed 4880460Kanner L. Autistic disturbances of affective contact. Acta Paedopsychiatr. 1968;35(4):100-36. No abstract available.
- Background: PubMed 30769834Stegemann T, Geretsegger M, Phan Quoc E, Riedl H, Smetana M. Music Therapy and Other Music-Based Interventions in Pediatric Health Care: An Overview. Medicines (Basel). 2019 Feb 14;6(1):25. doi: 10.3390/medicines6010025.
- Background: PubMed 22506303Lim HA, Draper E. The effects of music therapy incorporated with applied behavior analysis verbal behavior approach for children with autism spectrum disorders. J Music Ther. 2011 Winter;48(4):532-50. doi: 10.1093/jmt/48.4.532.
- Background: PubMed 20635521Lim HA. Effect of "developmental speech and language training through music" on speech production in children with autism spectrum disorders. J Music Ther. 2010 Spring;47(1):2-26. doi: 10.1093/jmt/47.1.2.
- BackgroundCarpente, J. A. Investigating the Effectiveness of a Developmental, Individual Difference, Relationship-Based (DIR) Improvisational Music Therapy Program on Social Communication for Children with Autism Spectrum Disorder. Music Therapy Perspectives 35, 160-174 (2017).
- Background: PubMed 24261547Thompson GA, McFerran KS, Gold C. Family-centred music therapy to promote social engagement in young children with severe autism spectrum disorder: a randomized controlled study. Child Care Health Dev. 2014 Nov;40(6):840-52. doi: 10.1111/cch.12121. Epub 2013 Nov 22.
- Background: PubMed 17419661Walworth DD. The use of music therapy within the SCERTS model for children with Autism Spectrum Disorder. J Music Ther. 2007 Spring;44(1):2-22. doi: 10.1093/jmt/44.1.2.
- Individual participant dataSharing planned: No
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Asperger's Disorder, Asperger Disorder
Not yet recruiting
Transdiagnostic Sleep and Circadian Treatment for Autistic Adolescents
Sleep, Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Artur Jaschke, PhD contact
Jonathan Pool, PhD principal investigator
Cambridge Institute for Music Therapy Research. Anglia Ruskin University, Cambridge
David M. David M. Greenberg, PhD principal investigator
Musical Universe Inc. USA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improvisational Music Therapy in people with Autism, run by Prof Simon Baron-Cohen at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simon Baron-Cohen, Professor (01223 465215, sb205@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change of the total score of the Brief Observation of Social Communication Change (BOSCC). One of three versions of the BOSCC will be used depending on the child's level of verbal communication. (time frame: Baseline and at the end of intervention (13 weeks after randomisation).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06016621, which also lists 54 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.