Efficacy of Music Therapy on Social Competence in Children with Autism Spectrum Disorder- A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- NA
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in CDDC Social Competence Score from baseline after 8 weeks of music therapy plus SOC VS SOC
研究概览
简要总结
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Background
Autism Spectrum disorder is a neuro-developmental condition of childhood characterized by qualitative impairment in social and communicative behaviour. There are different modalities that can be used in therapy for autism :one such intervention that can be applied in children with autism is music therapy. Music is a domain of preserved skills and interest in ASD. Music Therapy is a form of clinical application of music and its element as a therapeutic medium to address cognitive, developmental and adaptive and rehabilitative goals in the areas cognitive , psychosocial , language ,sensory and motor functions in individuals with disabilities. The present protocol aims to assess the efficacy of music therapy in social competency in children with ASD. This Study aims to assess the efficacy of Music Therapy in social competence .It will be tested in our cultural context with Music Therapy Protocol indigineous model and will be assessed with instruments developed in India (CDDC and ISAA).
Objectives
Primary objective**-**
To compare the change in social skill score (measured by change in CDDC score) from baseline after 8 weeks with Music therapy plus Standard of Care (SOC) versusSOC in Children with Autism Spectrum disorders.
Secondary objective-
· To compare the change in other domains (measured by change in CDDC scores) from baseline after 8 weeks with Music therapy plus standard of care vs standard of care
· To compare the change in Sensory Profile score **(**measured by change in SP-2 score) from baseline after 8 weeks with Music therapy plus standard of care vs standard of care
· To compare the change in symptom severity score (measured by change in Indian Scale for Assessment of Autism) from baseline after 8 weeks treatment with Music therapy plus standard of care vs standard of care . In children with Autism spectrum disorder;
Methods
This study is a Randomised Control Trial .Children with Autism Spectrum Disorder who are already being diagnosed based on the DSM 5 criteria are selected based on the inclusion and exclusion criteria. There will be a baseline application of CDDC, ISSA , SP-2. Children will be Allocated into two groups ,one getting music therapy and standard of care and the other group getting standard of care. Primary and Secondary outcome assessment will be done.and analysis will be done as per ITT , PP. After 8 weeks of the therapy the children will be clinically assessed using CDDC , ISSA, SP2.
Expected outcome
Music therapy is expected to improve social skills and emotional expression in children with autism spectrum disorder and therefore may be recommended later on as therapy in these children, if found effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •All children clinically diagnosed with ASD according to DSM 5 Children with ASD with age range 2-6 years Able to attend sessions continuously with no more than four absences.
排除标准
- •Significant medical or sensory or motor impairments A traumatic head injury or neurological condition Developmental quotient less than 70 Already on therapy with improvement in social emotional skill.
结局指标
主要结局
Change in CDDC Social Competence Score from baseline after 8 weeks of music therapy plus SOC VS SOC
时间窗: 0,8 weeks
次要结局
- Change in other developmental domain score measured by CDDC Score from baseline after 8 weeks of music therapy plus SOC VS SOC.
- Change in Sensory profile score measured by SP2 from baseline after 8 weeks of music therapy plus SOC VS SOC.
- Change in symptom severity score score measured by ISSA from baseline after 8 weeks of music therapy plus SOC VS SOC.
- To evaluate the change in play behaviour score measured by change in ChiPPA score post musical therapy plus SOC VS SOC.(0,8 weeks)
研究者
Snigdha Chand
All India Institute Of Medical Sciences ,Patna