Music for Autism: Binational Randomised Controlled Trial of Music Therapy Versus Play Therapy for Autistic Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Brain connectivity of frontotemporal regions
研究概览
简要总结
The Music for Autism (M4A) trial evaluates the neurobehavioral outcomes of a music therapy (MT) intervention, compared to a matched play therapy (PT) intervention, on social communication skills, brain connectivity and structural brain changes. In a crossover randomised controlled trial (RCT), 80 children with autism across all levels of functioning, aged 6-12 years, undergo a baseline assessment, which includes measurements of social communication, participation, functional connectivity and brain structure. Participants are then randomly allocated to a sequence of interventions (MT-PT or PT-MT) and assessments are taken before and after each intervention period. Both interventions will target common goals and follow the same structure, while at the same time allowing for flexibility in the therapists' approach. It is hypothesized that 12 weeks of intervention through MT, compared to PT, will improve social communication skills, participation, and other relevant mental health outcomes in children with autism spectrum disorder (ASD), as well as regulate resting-state functional over and under-connectivity and increase grey and white matter volume in specified regions. The investigators also expect changes in functional brain connectivity to correlate with behavioural outcome measures, specifically with improved social communication skills.
详细描述
M4A will combine biomedical research with clinical outcome research to investigate if 12 weeks of intervention through MT, compared to PT, improve social communication skills, participation, family quality of life, receptive vocabulary, adaptive behavior, and symptom severity in children with ASD, and if this is accompanied by a change in resting state functional connectivity (rsFC) as well as grey and white matter volume change. Additional mental health outcomes include not only core areas of impairment, but also associated problems such as chronic stress, which is a significant issue for people with ASD; impedes learning; and can be reduced through music, both as an outcome in itself and as a mediator for other health outcomes.
M4A will also investigate if clinical improvement is correlated with an increase of rsFC between auditory and striatal/fronto-motor regions as well as a decrease of rsFC between auditory and visual regions in MT compared to PT. Possible changes in grey/white matter volume will be measured by voxel-based morphometry (VBM) in a whole-brain scan before and after the interventions.
Sample size and power: This study will be powered for an effect size of d=0.34. With a two-sided significance level of 5%, a sample of n=70 will be required to detect the effect with 80% power. Attrition is expected at <10%; the study will therefore recruit at least 80 participants. More specifically, the investigators expect to find a mean difference of 4.84 (SD=14.24), corresponding to an effect size d=0.34, on the primary outcome. The investigators expect the scores to be correlated within participants by r≥0.50. Sample size to achieve 80% test power was calculated in R.
Treatment fidelity: All sessions will be recorded on video to help ensure and assess treatment fidelity. Fidelity will be rated by 2 raters, who are trained on a manual for assessment of treatment fidelity, on 4 different dimensions: (1.) Program adherence (number of sessions completed; number and types of activities covered, from the therapist's weekly reports); (2.) Process fidelity (delivery of the theoretical concepts of the intervention); (3.) Content fidelity (establishment of a therapeutic relationship between the participant and the therapist, measured using quality of delivery and participant responsiveness as well as the theoretical principles underlying the interventions); (4.) Programme differentiation between MT and PT ("Music was central to this activity").
Statistical analysis of behavioural outcomes will compare change from before to after each intervention within each participant. The intention-to-treat principle will be followed as applicable in a crossover trial: Participants will be analysed in the group to which they were randomised, regardless of whether they actually received the full allocated intervention. The main analysis will include all participants with valid data for both intervention periods; in addition, multiple imputation of missing outcomes will be used as a sensitivity analysis. Tests will use a two-sided 5% significance level. The two main secondary outcomes, participation and quality of life, will be Bonferroni corrected; the remaining secondary outcomes will be exploratory. Analysis software will be R.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
To ensure blinding, the primary outcome measure will be completed by special educators who are familiar with the child (rather than their parents). Success of blinding (for all outcomes) will be verified at the last follow-up.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meet diagnostic criteria as specified in Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-V) and officially diagnosed with autism spectrum disorder (ASD) by a licensed clinical professional using standardised diagnostic tools (Autism Diagnostic Observation Schedule (ADOS), Autism Diagnostic Interview Revised (ADI-R)).
排除标准
- •Recent or current music therapy
- •Metallic or electronic implants
研究组 & 干预措施
Music therapy/Play therapy
This sequence of interventions begins with 12 weeks of music therapy intervention, followed by a 3 month washout period and concluding with 12 weeks of play therapy intervention.
Both interventions will consist of 12 weekly one-on-one sessions, 45 minutes each, conducted in the same setting by a licensed music therapist, in accordance with an intervention manual. Using a theoretically motivated approach, both interventions will target similar domains: creating a shared experience, building meaningful relationships, fostering self-expression. A varied set of activities combining therapist- and child-led interactions will target common goals: multisensory integration, verbal and social communication, emotion regulation, turn-taking, social appropriateness, and interaction. In both interventions, children can choose 4 activities per session using a visual schedule.
干预措施: Music Therapy (Behavioral)
Music therapy/Play therapy
This sequence of interventions begins with 12 weeks of music therapy intervention, followed by a 3 month washout period and concluding with 12 weeks of play therapy intervention.
Both interventions will consist of 12 weekly one-on-one sessions, 45 minutes each, conducted in the same setting by a licensed music therapist, in accordance with an intervention manual. Using a theoretically motivated approach, both interventions will target similar domains: creating a shared experience, building meaningful relationships, fostering self-expression. A varied set of activities combining therapist- and child-led interactions will target common goals: multisensory integration, verbal and social communication, emotion regulation, turn-taking, social appropriateness, and interaction. In both interventions, children can choose 4 activities per session using a visual schedule.
干预措施: Play therapy (Behavioral)
Play therapy/Music therapy
This sequence of interventions begins with 12 weeks of play therapy intervention, followed by a 3 month washout period and concluding with 12 weeks of music therapy intervention.
Both interventions will consist of 12 weekly one-on-one sessions, 45 minutes each, conducted in the same setting by a licensed music therapist, in accordance with an intervention manual. Using a theoretically motivated approach, both interventions will target similar domains: creating a shared experience, building meaningful relationships, fostering self-expression. A varied set of activities combining therapist- and child-led interactions will target common goals: multisensory integration, verbal and social communication, emotion regulation, turn-taking, social appropriateness, interaction. In both interventions, children can choose 4 activities per session using a visual schedule.
干预措施: Music Therapy (Behavioral)
Play therapy/Music therapy
This sequence of interventions begins with 12 weeks of play therapy intervention, followed by a 3 month washout period and concluding with 12 weeks of music therapy intervention.
Both interventions will consist of 12 weekly one-on-one sessions, 45 minutes each, conducted in the same setting by a licensed music therapist, in accordance with an intervention manual. Using a theoretically motivated approach, both interventions will target similar domains: creating a shared experience, building meaningful relationships, fostering self-expression. A varied set of activities combining therapist- and child-led interactions will target common goals: multisensory integration, verbal and social communication, emotion regulation, turn-taking, social appropriateness, interaction. In both interventions, children can choose 4 activities per session using a visual schedule.
干预措施: Play therapy (Behavioral)
结局指标
主要结局
Brain connectivity of frontotemporal regions
时间窗: 12 weeks
Brain connectivity of frontotemporal regions will be measured as resting state functional connectivity (rsFC) from 6 seeds, will be used as the main neuroscientific outcome. Seeds will be anatomically defined regions of interest (ROIs) in Montreal Neurological Institute space for the left and right Heschl's gyrus, inferior frontal gyrus, and temporal pole.
Children's Communication Checklist-2
时间窗: 12 weeks
The Children's Communication Checklist-2 is a measure designed to assess the communication skills of children. The caregiver-report scale measures aspects of pragmatic communication with 70 items across 10 subdomains. The standard general communication composite standard score will be used as a measure of a child's general pragmatics and communication ability. Scores on the general composite of the Children's Communication Checklist-2 have a mean of 100 (SD=15). Higher scores indicate better social-communication skills.
次要结局
- Child and Adolescent Scale of Participation(12 weeks)
- Grey and white matter volume (Structural brain changes)(12 weeks)
- Hair cortisol concentration(12 weeks)
- Peabody Picture Vocabulary Test- 4th edition(12 weeks)
- Beach Center Family Quality of Life Scale(12 weeks)
- Social Responsiveness Scale(12 weeks)
- Vineland Adaptive Behavior Scales(12 weeks)