A Randomised Controlled Trial on the Effectiveness of Improvisational Music Therapy for Autistic Children Aged 7 - 11 [Autism-CHIME Trial].
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Absolute change of the total score of the Brief Observation of Social Communication Change (BOSCC). One of three versions of the BOSCC will be used depending on the child's level of verbal communication.
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of individual sessions of improvisational music therapy for autistic children aged 7 - 11.
Researchers will compare the impact of adding improvisational music therapy to usual care alone for autistic children over a 12-week period.
Participants will be randomly assigned to one of the following two conditions: the Improvisational Music Therapy (intervention) Group or the support as usual (control) Group.
The aim is to achieve seven overarching objectives:
- To determine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving social communication in autistic children.
- To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving communication skills in autistic children.
- To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in reducing psychosocial problems in autistic children.
- To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving wellbeing of autistic children.
- To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving adaptive functioning in autistic children.
- To examine whether 12 weeks of individual sessions of improvisational music therapy in addition to support as usual is superior to support as usual alone in improving anxiety in autistic children.
- To examine whether the therapeutic relationship predicts the development of social, communication and language skills among autistic children.
详细描述
Co-Chief Investigators Professor Simon Baron-Cohen Dr Carrie Allison Dr David M. Greenberg Dr. Jonathan Pool
Co-Investigators Dr Artur Jaschke
Advisor Emeritus Professor Helen Odell-Miller Dr. Claire Howlin
The Autism-CHIME trial is designed as a rigorous Randomised Controlled Trial (RCT) of individual sessions of improvisational music therapy with autistic children. The trial will be conducted in mainstream and special schools located in Cambridgeshire, Peterborough, London, and the South and East of England. The number of schools involved will depend on the number of eligible children willing to participate, with a minimum of 5-10 children per school.
Enrolled participants will undergo 1:1 block randomisation, to either support as usual plus improvisational music therapy sessions (intervention arm) or support as usual (control arm). Randomisation will occur after the baseline assessments have been completed. Participants will be stratified based on the version of the Brief Observation of Social Communication Change (BOSCC) that they are allocated (primary outcome measure): (1) Minimally Verbal, (2) Phrase Speakers, or (3) Fluent Speakers, so that there are equal numbers in each group, and that the control group and experimental group are balanced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Research assistants involved in data collection will be blinded to treatment allocation for the entire duration of the study. Success of blinding will be verified by asking assessors if they inadvertently found out about the treatment allocation - instances of unblinding will be recorded using a case report form with details including information on who was unblinded, the source of the unblinding and the reason for the unblinding.
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 7 to 11 years.
- •A clinical diagnosis of autism made by a qualified professional according to the International Classification of Diseases (ICD) 10th Revision criteria. Confirmed by a copy of the clinical report detailing the diagnosis (if available) or verified verbally by the child's parents.
- •Parents/guardians must give informed consent for their children to be enrolled in the trial.
- •Parents/guardians must be willing for the music therapy sessions and BOSCC assessments to be video recorded for monitoring and research purpose
- •Participants must be willing to attend two music therapy sessions per week for the duration of the trial.
- •Non-verbal children may be included
排除标准
- •Received regular individual music therapy in the preceding year as this would be likely to have a strong influence on the course of therapy.
- •Severe hearing deficit as this would alter the aim, course, and implementation of therapy.
- •Caregivers that are unable to attend for the psychological assessments with their child.
- •Caregivers without a basic understanding of English.
结局指标
主要结局
Absolute change of the total score of the Brief Observation of Social Communication Change (BOSCC). One of three versions of the BOSCC will be used depending on the child's level of verbal communication.
时间窗: Baseline and at the end of intervention (13 weeks after randomisation).
The BOSCC consists of specific items that were developed to identify changes in social-communication behaviours over relatively short periods of time by quantifying subtleties in both the frequency and the quality of specific behaviours. There are three forms of the BOSCC: one for individuals who are minimally verbal (MV), one for those with phrase speech/young fluent speakers (PS/YF up to age 6 - 8) and one for fluent speakers (F1/F2 with two sets of materials, one for children and one for adolescents and adults). Scores are based on the observation of social communicative behaviour during naturalistic interactions between a child and an adult.
次要结局
- Absolute change of the total score of the Parent-Rated Anxiety Scale (PRAS) for Youth with Autism Spectrum Disorder (ASD) as a measure of anxiety.(Baseline, 13 and 39 weeks after randomisation.)
- Absolute change of the total score of the Strengths and Difficulties Questionnaire to test improvement in psychosocial difficulties(Baseline, 13 and 39 weeks after randomisation.)
- Absolute change of the total score of the Young Child Outcome Rating Scale (YCORS) as a measure of wellbeing.(Baseline, 13 and 39 weeks after randomisation.)
- Absolute change of the total score of the Music Therapy Communication and Social Interaction Scale (MTCSI) (or Music Engagement Scale, MES) based on video recordings.(Weeks 1 and 12.)
- Absolute change of the total score of the BOSCC.(Baseline and 39 weeks after randomisation.)
- Absolute change of the total score of the Vineland-3 Domain level parent/caregiver form to test improvement in adaptive functioning.(Baseline, 13 and 39 weeks after randomisation.)
- Absolute change of the total score of the Children's Communication Checklist-2 to test improvement in communication skills.(Baseline, 13 and 39 weeks after randomisation.)
- Association between the therapeutic relationship and the development of social, communication and language skills.(Weeks 1 and 12)
研究者
Prof Simon Baron-Cohen
Professor Simon Baron-Cohen
University of Cambridge