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document
Randomised controlled trial of improvisational music therapy 's effectiveness for children with autism spectrum disorders ( TIME-A ) : study protocol . BACKGROUND Previous research has suggested that music therapy may facilitate skills in areas typically affected by autism spectrum disorders such as social interaction and communication . However , generalisability of previous findings has been restricted , as studies were limited in either methodological accuracy or the clinical relevance of their approach . The aim of this study is to determine effects of improvisational music therapy on social communication skills of children with autism spectrum disorders . An additional aim of the study is to examine if variation in dose of treatment ( i.e. , number of music therapy sessions per week ) affects outcome of therapy , and to determine cost-effectiveness . METHODS/DESIGN Children aged between 4 ; 0 and 6 ; 11 years who are diagnosed with autism spectrum disorder will be randomly assigned to one of three conditions . Parents of all participants will receive three sessions of parent counselling ( at 0 , 2 , and 5 months ) . In addition , children randomised to the two intervention groups will be offered individual , improvisational music therapy over a period of five months , either one session ( low-intensity ) or three sessions ( high-intensity ) per week . Generalised effects of music therapy will be measured using standardised scales completed by blinded assessors ( Autism Diagnostic Observation Schedule , ADOS ) and parents ( Social Responsiveness Scale , SRS ) before and 2 , 5 , and 12 months after randomisation . Cost effectiveness will be calculated as man years . A group sequential design with first interim look at N = 235 will ensure both power and efficiency . DISCUSSION Responding to the need for more rigorously designed trials examining the effectiveness of music therapy in autism spectrum disorders , this pragmatic trial sets out to generate findings that will be well generalisable to clinical practice . Addressing the issue of dose variation , this study 's results will also provide information on the relevance of session frequency for therapy outcome . TRIAL REGISTRATION Current Controlled Trials ISRCTN78923965 .
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Intervention_Psychological
improvisational music therapy 's
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Intervention_Psychological
music therapy
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Intervention_Educational
three sessions of parent counselling
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Intervention_Psychological
individual , improvisational music therapy
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Outcome_Other
effectiveness
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Outcome_Mental
skills
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Outcome_Mental
social interaction and communication
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Outcome_Mental
social communication skills
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Outcome_Mental
outcome of therapy
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Outcome_Other
cost-effectiveness
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Outcome_Other
standardised scales
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Outcome_Mental
( Autism Diagnostic Observation Schedule , ADOS )
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Outcome_Mental
parents ( Social Responsiveness Scale , SRS )
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Outcome_Other
Cost effectiveness
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Outcome_Mental
session frequency
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Participant_Age
children
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Participant_Condition
autism spectrum disorders
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Participant_Condition
autism spectrum disorders
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Participant_Age
children
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Participant_Condition
autism spectrum disorders
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Participant_Age
Children aged between 4 ; 0 and 6 ; 11 years
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Participant_Condition
autism spectrum disorder
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Participant_Condition
autism spectrum disorders