Condition category
Mental and Behavioural Disorders
Date applied
18/06/2011
Date assigned
04/08/2011
Last edited
12/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 child’s (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

Trial website

http://uni.no/en/uni-health/gamut/trial-of-improvisational-music-therapys-effectiveness-for-children-with-autism-time-a/

Contact information

Type

Scientific

Primary contact

Prof Christian Gold

ORCID ID

Contact details

Uni Research Health
GAMUT - The Grieg Academy Music Therapy Research Centre
Postboks 7810
Bergen
5020
Norway
+47 (0)975 01 757
christian.gold@uni.no

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Randomised controlled Trial of Improvisational Music therapy’'s Effectiveness for children with Autism spectrum disorders (TIME-A)

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

Approval by the responsible ethics committees will be secured before the start of participants’ enrolment at each site

Study design

Multi-centre three-arm single (rater) blind randomised controlled trial of intervention

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/08/2011

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

300 (75 in each intervention arm, 150 in the standard care condition)

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

Trial participating centre

Grieg Academy Music Therapy Research Centre (GAMUT)
Bergen
5015
Norway

Sponsor information

Organisation

GAMUT - The Grieg Academy Music Therapy Research Centre

Sponsor details

Uni Research Health
Postboks 7810
Bergen
5020
Norway

Sponsor type

Research organisation

Website

http://helse.uni.no/

Funders

Funder type

Research council

Funder name

Norges Forskningsråd

Alternative name(s)

Research Council of Norway, Forskningsrådet, Norwegian Research Council

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Norway

Funder name

Universitetet i Bergen

Alternative name(s)

University of Bergen, UiB

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Norway

Funder name

University of Melbourne

Alternative name(s)

Melbourne University

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Australia

Funder name

Det Frie Forskningsråd

Alternative name(s)

Danish Council for Independent Research, DFF

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Denmark

Funder name

Aalborg Universitet

Alternative name(s)

Aalborg University, AAU

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Denmark

Funder name

Universität Wien

Alternative name(s)

University of Vienna

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Austria

Funder name

Hospital de Clínicas de Porto Alegre

Alternative name(s)

HCPA

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Brazil

Funder name

IRCCS Stella Maris Foundation, Pisa

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Università di Pisa

Alternative name(s)

Università degli Studi di Pisa, University of Pisa, UniPi

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Italy

Funder name

Jeonju University

Alternative name(s)

JJ

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Korea, South

Funder name

Helse Vest

Alternative name(s)

Western Norway Regional Health Authority, WNRHA, Helse Vest Regionalt Helseføretak, Helse Vest RHF

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Norway

Funder name

Bergen municipality, Bergen culture school

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fjell municipality, Fjell culture school

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

Cambridge and Peterborough Foundation NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Evelyn Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Cambridgeshire Music

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Anglia Ruskin University

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Funder name

Molloy College

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

American Music Therapy Association

Alternative name(s)

American Music Therapy Association, Inc., AMTA

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Results and Publications

Publication and dissemination plan

Planned publication in a peer-reviewed journal.

IPD sharing statement:
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).

Intention to publish date

31/12/2017

Participant level data

Stored in repository

Results - basic reporting

Publication summary

2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22221670
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26019303 (treatment guidelines)
2016 pilot cohort results in: http://www.ncbi.nlm.nih.gov/pubmed/27084832
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28787504
2017 editorial in: http://www.ncbi.nlm.nih.gov/pubmed/28787492

Publication citations

Additional files

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.