Trial of improvisational music therapy's effectiveness for children with autism

ISRCTN	ISRCTN78923965
DOI	https://doi.org/10.1186/ISRCTN78923965
Protocol serial number	N/A
Sponsor	GAMUT - The Grieg Academy Music Therapy Research Centre
Funders	Norges Forskningsråd, Universitetet i Bergen, University of Melbourne, Det Frie Forskningsråd, Aalborg Universitet, Universität Wien, Hospital de Clínicas de Porto Alegre, IRCCS Stella Maris Foundation, Pisa , Università di Pisa, Jeonju University, Helse Vest, Bergen municipality, Bergen culture school , Fjell municipality, Fjell culture school , National Institute for Health Research, Cambridge and Peterborough Foundation NHS Trust , Evelyn Trust, Cambridgeshire Music , Anglia Ruskin University, Molloy College, American Music Therapy Association

Submission date: 18/06/2011
Registration date: 04/08/2011
Last edited: 12/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Autism spectrum disorders (ASDs) involve impairments or delayed development in social interaction and communication skills. A wide range of different approaches have been used to help children with ASD develop these skills. However, there is little evidence of effectiveness for most of these methods. Music therapy has been used to treat ASD for a long time, and there are many studies suggesting that music therapy may enhance social communication skills. The aim of this study is to find out about the effects of improvisational music therapy on the social communication skills of children with ASD. Additional aims are to examine if changing the number of music therapy sessions per week affects the outcome of therapy, and to determine cost-effectiveness.

Who can participate?
Children aged between 4 years and 6 years 11 months diagnosed with ASD. Participating children must not be affected by serious sensory disorders (blindness, deafness) and must not have received music therapy in the last 12 months

What does the study involve?
Participants are randomly allocated to one of three groups:
1. High-intensity music therapy (improvisational music therapy sessions three times per week for five months, and three sessions of parent counselling).
2. Low-intensity music therapy (improvisational music therapy sessions once a week for five months, and three sessions of parent counselling).
3. Standard care (three sessions of parent counselling).
Improvisational music therapy is a flexible, child-centred method where a trained therapist reacts musically to the childs (musical or other) behaviour and expression and uses various improvisational techniques to engage the child, establish contact, and enter a dialogue with him/her. While engaging in joint musical activities within a shared history of interaction, the child is offered opportunities to develop and enhance skills that are associated with later development in language and social competency.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.

Where is the study run from?
Uni Research Health, The Grieg Academy Music Therapy Research Centre (GAMUT), Bergen (Norway)

When is the study starting and how long is it expected to run for?
August 2011 to December 2016

Who is funding the study?
1. The Research Council of Norway (Norway)
2. POLYFON Knowledge Cluster for Music Therapy, The Grieg Academy Department of Music, University of Bergen (Norway)
3. Melbourne Conservatorium of Music, The University of Melbourne (Australia)
4. Danish Council for Independent Research/Humanities (FKK) (Denmark)
5. Doctoral Programme in Music Therapy, Aalborg University (Denmark)
6. Faculty of Psychology, University of Vienna (Austria)
7. Research Incentive Fund (FIPE) of the Hospital de Clínicas de Porto Alegre (HCPA) (Brazil)
8. IRCCS Stella Maris Foundation, Pisa (Italy)
9. University of Pisa (Italy)
10. Research Institute of Health and Science, Jeonju University (Korea)
11. Health Authority of Western Norway (Norway)
12. Bergen municipality, Bergen culture school (Norway)
13. Fjell municipality, Fjell culture school (Norway)
14. National Institute for Health Research (UK)
15. Cambridge and Peterborough Foundation NHS Trust (UK)
16. The Evelyn Trust (UK)
17. Cambridgeshire Music (UK)
18. Anglia Ruskin University (UK)
19. Molloy College (USA)
20. Mid-Atlantic Region of the American Music Therapy Association (USA)

Who is the main contact?
Prof. Christian Gold
christian.gold@uni.no

Contact information

Prof Christian Gold
Scientific

Uni Research Health
GAMUT - The Grieg Academy Music Therapy Research Centre
Postboks 7810
Bergen
5020
Norway

Phone	+47 (0)975 01 757
Email	christian.gold@uni.no

Study information

Primary study design	Interventional
Study design	Multi-centre three-arm single (rater) blind randomised controlled trial of intervention
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Randomised controlled Trial of Improvisational Music therapy's Effectiveness for children with Autism spectrum disorders (TIME-A)
Study acronym	TIME-A
Study objectives	Music therapy is superior to standard care in improving social communicative skills in children with autism spectrum disorders (ASD) as assessed by blinded clinicians at the end of the treatment period Secondary hypotheses 1. Music therapy is superior to standard care in improving social responsiveness in children with ASD as assessed by parents/guardians at the end of the treatment period 2. Change in social communicative skills and social responsiveness varies with variation of treatment intensity 3. Changes in social communicative skills and social responsiveness are sustained until seven months after ending of treatment
Ethics approval(s)	Approval by the responsible ethics committees will be secured before the start of participants enrolment at each site
Health condition(s) or problem(s) studied	Autism spectrum disorders
Intervention	1. Individual improvisational music therapy over a period of 5 months, one session (low-intensity) or three sessions (high-intensity) per week 2. Standard care in all treatment arms: 3 sessions of parent counselling at 0, 2, and 5 months
Intervention type	Other
Primary outcome measure(s)	Autism Diagnostic Observation Schedule (ADOS) Social Affect score at 5 months
Key secondary outcome measure(s)	1. ADOS at 2 and 12 months 2. ADOS subscales: Communication, Reciprocal Social Interaction, Imagination/Creativity, Stereotyped Behaviors and Restricted Interests, at 2, 5, and 12 months 3. Social Responsiveness Scale (SRS) as rated by parents/guardians at 2, 5, and 12 months 4. SRS subscales: Social Awareness (receptive aspects of social behavior), Social Cognition (social information processing), Social Communication (capacity for reciprocal social communication), Social Motivation (social anxiety/avoidance), Autistic Mannerisms (autistic preoccupations and traits) 5. Cost-effectiveness ratios and incremental cost-effectiveness ratios for the different alternatives (Cost will be measured as real resources used in treatment, in terms of personnel hours of work; effectiveness is measured by ADOS) Added 05/06/2017: 6. Ratings of quality of life of the child and of the family as a whole, respectively, at 2, 5 and 12 months 7. Adverse events 8. Binary analysis of proportion of participants who improved on the primary outcome
Completion date	31/12/2016

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	4 Years
Upper age limit	6 Years
Sex	All
Target sample size at registration	300
Key inclusion criteria	1. Aged 4 years to 6 years, 11 months 2. With a diagnosis of autism spectrum disorder according to ICD-10 criteria as assessed by a child psychiatrist or clinical psychologist; diagnosis of ASD needs to be reconfirmed in the baseline assessment with children fulfilling diagnostic criteria for ASD on both the Autism Diagnostic Observation Schedule (ADOS) and the Autism Diagnostic Interview-Revised (ADI-R)
Key exclusion criteria	1. Children with serious sensory disorders (blindness, deafness) 2. Children who have had any previous experience of music therapy
Date of first enrolment	01/11/2011
Date of final enrolment	10/11/2015

Locations

Countries of recruitment

United Kingdom
Australia
Austria
Brazil
Israel
Italy
Korea, South
Norway
United States of America

Study participating centre

Grieg Academy Music Therapy Research Centre (GAMUT)

Bergen
5015
Norway

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan	The datasets generated during and/or analysed during the study will be stored in a publically available repository (NSD - Norwegian Centre for Research Data, http://www.nsd.uib.no/nsd/english/index.html).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2015		Yes	No
Results article	pilot cohort results	01/06/2016		Yes	No
Results article	results	08/08/2017		Yes	No
Protocol article	protocol	05/01/2012		Yes	No
Other publications	editorial	08/08/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

12/10/2017: Publication reference added.
09/08/2017: Publication reference added.
08/06/2017: The IPD sharing plan has been added.
05/06/2017: 14 additional funders have been added and the secondary outcome measures have been updated.
01/06/2016: The recruitment dates have been updated from 01/08/2011 - 30/06/2016 to 01/11/2011 - 10/11/2015. The overall trial end date has been updated from 30/06/2016 to 31/12/2016. Additionally, the National Institute for Health Research (UK) has been added as a funder, and the funder "Grieg Academy Music Therapy Research Centre, Bergen, Norway" has been amended to The Research Council of Norway.
29/07/2013: Italy and United Kingdom were added to the countries of recruitment.

Trial of improvisational music therapy's effectiveness for children with autism