randomised controlled trial of improvisational music therapys effectiveness for children with autism spectrum disorders (time-a) study protocol随机对照试验的即兴音乐疗法的有效性对儿童自闭症谱系障碍(时间)研究协议.pdfVIP

Geretsegger et al. BMC Pediatrics 2012, 12:2 /1471-2431/12/2 STUDY PROTOCOL Open Access Randomised controlled trial of improvisational music therapy’s effectiveness for children with autism spectrum disorders (TIME-A): study protocol Monika Geretsegger1,2, Ulla Holck1 and Christian Gold3* Abstract 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 f