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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06110884
Other study ID # 202307099RIND
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date December 31, 2026

Study information

Verified date October 2023
Source National Taiwan University Hospital
Contact Chih-en Liu, university
Phone 886-3-5326151
Email G03486@hch.gov.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 3 Years to 5 Years
Eligibility 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

Study Design


Intervention

Behavioral:
music therapy, speech therapy
receive group music therapy in addition to traditional language therapy
speech therapy
receive only traditional language therapy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Revised version of the Preschool Language Scale (PLS) assess the language abilities of children, minimum value 0, maximum value 83, higher scores means a better outcome 8 weeks
Primary Checklist for Autism Spectrum Disorder-Chinese Version (CASD-C) evaluate autism trait performance 8 weeks
Secondary Child Behavior Checklist for Ages 1½-5 (CBCL 1½-5) evaluate emotional behavior 8 weeks
Secondary Parenting Stress Index evaluate parent-child stress levels, minimum value 36, maximum value 180, higher scores means a worse outcome 8 weeks
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