Condition category
Mental and Behavioural Disorders
Date applied
18/06/2011
Date assigned
04/08/2011
Last edited
15/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
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 had any previous experience of music therapy.

What does the study involve?
Participants will be 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?
No adverse effects are expected.

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

When is the study starting and how long is it expected to run for?
The study started in August 2011 and will end in June 2016.

Who is funding the study?
Grieg Academy Music Therapy Research Centre (GAMUT), Bergen, Norway.

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

Trial website

http://helse.uni.no/timea

Contact information

Type

Scientific

Primary contact

Prof Christian Gold

ORCID ID

Contact details

Grieg Academy Music Therapy Research Centre (GAMUT)
Lars Hilles Gate 3
Bergen
5015
Norway
christian.gold@grieg.uib.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

On 29/07/2013 Italy and United Kingdom were added to the countries of recruitment.

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

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Autism spectrum disorders

Intervention

1. Individual improvisational music therapy over a period of five 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

1. Autism Diagnostic Observation Schedule (ADOS) – social communication algorithm score at 5 months
2. Assessors administering the instrument will be blinded to group allocation of the children to be assessed

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)

Overall trial start date

01/08/2011

Overall trial end date

30/06/2016

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

01/08/2011

Recruitment end date

30/06/2016

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, Uni Health, Uni Research, Bergen (Norway)

Sponsor details

c/o Prof Christian Gold
Lars Hilles Gate 3
Bergen
5015
Norway

Sponsor type

Research organisation

Website

http://helse.uni.no/

Funders

Funder type

University/education

Funder name

GAMUT, University Research, Bergen (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Doctoral Programme in Music Therapy, Aalborg University (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Faculty of Psychology, University of Vienna (Austria)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Danish Council for Independent Research/Humanities (FKK), Copenhagen (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22221670

Publication citations

  1. Protocol

    Geretsegger M, Holck U, Gold C, Randomised controlled trial of improvisational music therapy's effectiveness for children with autism spectrum disorders (TIME-A): study protocol., BMC Pediatr, 2012, 12, 2, doi: 10.1186/1471-2431-12-2.

Additional files

Editorial Notes