Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05302167 - Molehill Mountain Feasibility Study. N/A
Completed NCT04167839 - Effects of Sensory Diets on Children's Sensory Processing Skills, Psychosocial Skills, and Classroom Engagement N/A
Terminated NCT04049981 - Investigation of Mechanisms of Action in Superpower Glass Phase 1/Phase 2
Active, not recruiting NCT06080087 - Implementation Toolkit to Enhance EBP Among Marginalized Families N/A
Recruiting NCT04107064 - Achieving Steady Work Among Adults With Autism Through Specialized Employment Program N/A
Completed NCT03206996 - Exposure Therapy for Auditory Sensitivity in Autism N/A
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Completed NCT05588570 - Coaching Children With Anxiety and Autism Through Telehealth N/A
Enrolling by invitation NCT06058104 - Evaluating Efficacy of a Digital Game Therapeutic for Children With Autism N/A
Completed NCT02911194 - a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD) N/A
Completed NCT03002363 - The Effects of Video Modeling of Audiological Testing on Pediatric Patient Compliance Phase 1
Withdrawn NCT02414451 - Trial of Propranolol in Adults and Adolescents With ASD and Predictors of Response N/A
Completed NCT02847182 - Cord Blood Infusion for Children With Autism Spectrum Disorder Phase 2
Completed NCT02720900 - Prebiotic Intervention for Autism Spectrum Disorders N/A
Completed NCT02536365 - Sensory Integration Therapy in Autism: Mechanisms and Effectiveness N/A
Completed NCT02708290 - Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD
Completed NCT02508922 - Trial of Vitamin D3 Supplementation in Paediatric Autism N/A
Recruiting NCT02255565 - Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study Phase 4
Recruiting NCT01836562 - A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism Phase 1/Phase 2
Completed NCT02154828 - Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)