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

NCT06110884 | Recruiting

• 1 other identifier: 202307099RIND
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism; Language Delay; Speech Disorders in Children

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Child Behavior Checklist for Ages 1½-5 (CBCL 1½-5)

  8 weeks

• Parenting Stress Index

  8 weeks

Study Arms (2)

Music therapy group

EXPERIMENTAL

Behavioral: music therapy, speech therapy

Control group

ACTIVE COMPARATOR

Behavioral: speech therapy

Interventions

music therapy, speech therapy BEHAVIORAL

receive group music therapy in addition to traditional language therapy

Music therapy group

speech therapy BEHAVIORAL

receive only traditional language therapy

Control group

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Hsin-chu branch

Hsinchu, 300, Taiwan

RECRUITING

MeSH Terms

Conditions

Autistic Disorder; Language Development Disorders

Interventions

Music Therapy; Speech Therapy

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation of Speech and Language Disorders

Central Study Contacts

Chih-en Liu, university

CONTACT

886-3-5326151; G03486@hch.gov.tw

Shu-mei Yang, MD

CONTACT

886-972653754; b99401109@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 1, 2023
• Study Start: January 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 30, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)