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Trial of Improvisational Music therapy’s Effectiveness for children with Autism (TIME-A)
ISRCTN ISRCTN78923965
DOI 10.1186/ISRCTN78923965
ClinicalTrials.gov identifier
EudraCT number
Public title Trial of Improvisational Music therapy’s Effectiveness for children with Autism (TIME-A)
Scientific title Randomised controlled Trial of Improvisational Music therapy’s Effectiveness for children with Autism spectrum disorders (TIME-A)
Acronym TIME-A
Serial number at source N/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.
Lay 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
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
Countries of recruitment Australia, Austria, Brazil, Israel, Italy, Korea, South, Norway, United Kingdom, United States of America
Disease/condition/study domain Autism spectrum disorders
Participants - 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)
Participants - exclusion criteria 1. Children with serious sensory disorders (blindness, deafness)
2. Children who have had any previous experience of music therapy
Anticipated start date 01/08/2011
Anticipated end date 30/06/2016
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 300 (75 in each intervention arm, 150 in the standard care condition)
Interventions 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
Primary outcome measure(s) 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 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)
Sources of funding 1. GAMUT, University Research, Bergen (Norway)
2. Doctoral Programme in Music Therapy, Aalborg University (Denmark)
3. Faculty of Psychology, University of Vienna (Austria)
4. The Danish Council for Independent Research/Humanities (FKK), Copenhagen (Denmark)
Trial website http://helse.uni.no/timea
Publications 1. 2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/22221670
Contact name Prof  Christian  Gold
  Address Grieg Academy Music Therapy Research Centre (GAMUT)
Lars Hilles Gate 3
  City/town Bergen
  Zip/Postcode 5015
  Country Norway
  Email christian.gold@grieg.uib.no
Sponsor GAMUT, Uni Health, Uni Research, Bergen (Norway)
  Address c/o Prof Christian Gold
Lars Hilles Gate 3
  City/town Bergen
  Zip/Postcode 5015
  Country Norway
  Sponsor website: http://helse.uni.no/
Date applied 18/06/2011
Last edited 15/11/2013
Date ISRCTN assigned 04/08/2011
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