Music Therapy for Speech and Prosody in Autistic Children (MTSPAC)

Effectiveness of Music Therapy for Speech Delay and Prosody Disorder in Children With Autism

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.

Study Overview

• Status: Recruiting
• Conditions: Autism; Language Delay; Speech Disorders in Children
• Intervention / Treatment: Behavioral: music therapy, speech therapy; Behavioral: speech therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chih-en Liu, university; Phone Number: 523522 886-3-5326151; Email: G03486@hch.gov.tw
• Study Contact Backup: Name: Shu-mei Yang, MD; Phone Number: 886-972653754; Email: b99401109@gmail.com

Study Locations

• Taiwan
  • Hsinchu, Taiwan, 300
    • Recruiting
    • National Taiwan University Hospital Hsin-Chu Branch
    • Contact: CHIH EN LIU, Bachelor of speech therapy; Phone Number: +886-3-532-6151 ext. 523522; Email: G03486@hch.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Behavioral: speech therapy; receive only traditional language therapy
Experimental: Music therapy group	Behavioral: music therapy, speech therapy; receive group music therapy in addition to traditional language therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Checklist for Autism Spectrum Disorder-Chinese Version (CASD-C)	evaluate autism trait performance	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Behavior Checklist for Ages 1½-5 (CBCL 1½-5)	evaluate emotional behavior	8 weeks
Parenting Stress Index	evaluate parent-child stress levels, minimum value 36, maximum value 180, higher scores means a worse outcome	8 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: October 30, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 27, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Communication Disorders; Language Disorders; Speech Disorders; Language Development Disorders
• Other Study ID Numbers: 202307099RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We would like to consider sharing the acoustic measurement data with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No