Trial of improvisational music therapy's effectiveness for children with autism
| ISRCTN | ISRCTN78923965 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78923965 |
| Secondary identifying numbers | N/A |
- 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
Plain English Summary
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
Scientific
Uni Research Health
GAMUT - The Grieg Academy Music Therapy Research Centre
Postboks 7810
Bergen
5020
Norway
| Phone | +47 (0)975 01 757 |
|---|---|
| christian.gold@uni.no |
Study information
| Study design | Multi-centre three-arm single (rater) blind randomised controlled trial of intervention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient 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 hypothesis | 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 |
| Condition | 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 | Autism Diagnostic Observation Schedule (ADOS) Social Affect score at 5 months |
| Secondary outcome measures | 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 |
| Overall study start date | 01/08/2011 |
| Overall study end date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 6 Years |
| Sex | Both |
| Target number of participants | 300 (75 in each intervention arm, 150 in the standard care condition) |
| Participant 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) |
| Participant exclusion criteria | 1. Children with serious sensory disorders (blindness, deafness) 2. Children who have had any previous experience of music therapy |
| Recruitment start date | 01/11/2011 |
| Recruitment end date | 10/11/2015 |
Locations
Countries of recruitment
- Australia
- Austria
- Brazil
- Israel
- Italy
- Korea, South
- Norway
- United Kingdom
- United States of America
Study participating centre
5015
Norway
Sponsor information
Research organisation
Uni Research Health
Postboks 7810
Bergen
5020
Norway
| Website | http://helse.uni.no/ |
|---|---|
"ROR" |
https://ror.org/03zga2b32 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Forskningsrådet, Norwegian Research Council, Research Council of Norway
- Location
- Norway
Government organisation / Local government
- Alternative name(s)
- University of Bergen, UiB
- Location
- Norway
Private sector organisation / Universities (academic only)
- Alternative name(s)
- University of Melbourne in Australia, The University of Melbourne, Melbourne University, UNIMELB
- Location
- Australia
Government organisation / National government
- Alternative name(s)
- Danish Council for Independent Research, Det Frie Forskningsrad, Independent Research Fund Denmark, DFF
- Location
- Denmark
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Aalborg University, AAU
- Location
- Denmark
Private sector organisation / Universities (academic only)
- Alternative name(s)
- University of Vienna
- Location
- Austria
Government organisation / Universities (academic only)
- Alternative name(s)
- Hospital of Clinics of Porto Alegre, HCPA
- Location
- Brazil
No information available
Government organisation / Universities (academic only)
- Alternative name(s)
- Università degli Studi di Pisa, Universidad de Pisa, University of Pisa, UniPi
- Location
- Italy
Private sector organisation / Universities (academic only)
- Alternative name(s)
- JJ
- Location
- Korea, South
Government organisation / Local government
- Alternative name(s)
- Western Norway Regional Health Authority, WNRHA, Helse Vest Regionalt Helseføretak, Helse Vest RHF
- Location
- Norway
No information available
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
No information available
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
No information available
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
No information available
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- American Music Therapy Association, Inc., AMTA
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| 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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 05/01/2012 | Yes | No | |
| Results article | results | 01/06/2015 | Yes | No | |
| Results article | pilot cohort results | 01/06/2016 | Yes | No | |
| Other publications | editorial | 08/08/2017 | Yes | No | |
| Results article | results | 08/08/2017 | Yes | No |
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.
