Clinical trial NCT06110884: Music Therapy for Speech and Prosody in Autistic Children (MTSPAC)
Official title: Effectiveness of Music Therapy for Speech Delay and Prosody Disorder in Children With Autism
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism
Language Delay
Speech Disorders in Children
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-11-01
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is a single-blind randomized controlled trial, where the investigators plan to recruit 40 children with autism, randomly divided into two groups. The music therapy intervention group will receive an hour of group music therapy in addition to traditional language therapy. The control group will receive only traditional language therapy. The trial will last for 8 weeks, and participants in both groups will be assessed before and after the trial.

During the study, the investigators will use professional recording equipment to record their speech and use the speech analysis software to objectively compare whether there are significant differences in prosody between the two groups of children with autism before and after the intervention. Besides the acoustic measurement the investigators also assess the language abilities autism trait performance, adaptive function, emotional behavior, and parent-child stress levels.

Detailed description: This research is a single-blind randomized controlled trial, where the investigators plan to recruit 40 children with autism, randomly divided into two groups. The music therapy intervention group will receive an hour of group music therapy in addition to traditional language therapy. The control group will receive only traditional language therapy. The trial will last for 8 weeks, and participants in both groups will be assessed before and after the trial.

During the study, the investigators will use professional recording equipment to record their speech and use the speech analysis software to objectively compare whether there are significant differences in prosody between the two groups of children with autism before and after the intervention. Besides the acoustic measurement the investigators also assess the language abilities autism trait performance, adaptive function, emotional behavior, and parent-child stress levels.

The study hypothesizes that music therapy can contribute to improving language development delays in children with autism and may enhance their language development further by ameliorating prosody abnormalities. The investigators hope that this research can propose more diversified therapeutic methods for language development in children with autism.

Eligibility criteria: Inclusion Criteria:

* children with autism
* aged 3-5 y/o
* children with speech delay (T-score of Preschool Language Scale \< 40)
* Mandarin as first language

Exclusion Criteria:

* children with other neurological diseases
* children without verbal output
* children with articulation or voice disorder

Primary outcomes:
measure: Revised version of the Preschool Language Scale (PLS)
timeFrame: 8 weeks
measure: Checklist for Autism Spectrum Disorder-Chinese Version (CASD-C)
timeFrame: 8 weeks
Secondary outcomes:
measure: Child Behavior Checklist for Ages 1½-5 (CBCL 1½-5)
timeFrame: 8 weeks
measure: Parenting Stress Index
timeFrame: 8 weeks
Other outcomes:
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