- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06110884
Music Therapy for Language and Social Skills in Autistic Children
Effectiveness of Music Therapy for Speech Delay and Social Skills 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 assess the language abilities autism trait performance, adaptive function, emotional behavior, and parent-child stress levels.
Study Overview
Status
Conditions
Intervention / Treatment
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 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. The investigators hope that this research can propose more diversified therapeutic methods for language development in children with autism.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hsinchu, Taiwan, 300
- National Taiwan University Hospital Hsin-chu branch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control group
|
receive only traditional language therapy
|
|
Experimental: Music therapy group
|
receive group music therapy in addition to traditional language therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chinese version of the Preschool Language Scale (PLS)
Time Frame: 8 weeks
|
assess the language abilities of children, minimum value 0, maximum value 83, higher scores means a better outcome
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Checklist for Autism Spectrum Disorder-Chinese Version (CASD-C)
Time Frame: 8 weeks
|
evaluate autism trait performance
|
8 weeks
|
|
Child Behavior Checklist for Ages 1½-5 (CBCL 1½-5)
Time Frame: 8 weeks
|
evaluate emotional behavior
|
8 weeks
|
|
Parenting Stress Index
Time Frame: 8 weeks
|
evaluate parent-child stress levels, minimum value 36, maximum value 180, higher scores means a worse outcome
|
8 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Autism Spectrum Disorder
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Neurodevelopmental Disorders
- Child Development Disorders, Pervasive
- Communication Disorders
- Language Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Autistic Disorder
- Language Development Disorders
- Therapeutics
- Complementary Therapies
- Patient Care
- Psychotherapy
- Behavioral Disciplines and Activities
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Rehabilitation of Speech and Language Disorders
- Sensory Art Therapies
- Speech Therapy
- Music Therapy
Other Study ID Numbers
- 202307099RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autism
-
Fondazione I.R.C.C.S. Istituto Neurologico Carlo...Istituto Clinico HumanitasRecruitingAutism | Autism Spectrum Disorder (ASD) | Autism DisorderItaly
-
Istituto per la Ricerca e l'Innovazione BiomedicaRecruitingAutism | Autism DisorderItaly
-
University of NottinghamUniversity Hospitals of Derby and Burton NHS Foundation Trust; Lincolnshire...Not yet recruitingAutism Spectrum Disorder | Autism | Parent | Autism Disorder | Autism in Children | Parent Stress | Parent Mental Health | Autism Disorders and Maternal Stress | Parent SupportUnited Kingdom
-
Boston Children's HospitalRecruitingAutism Spectrum Disorder | Autism | Autism DisorderUnited States
-
The Children's Hospital of Zhejiang University...Not yet recruitingAutism | Autism Spectrum Disorder (ASD)China
-
Poznan University of Physical EducationCompletedAutism | Autism Spectrum Disorder (ASD)Poland
-
Greater Atlanta Integrative PediatricsRecruitingAutism Spectrum Disorder | Autism | ASD | Autism Spectrum Disorder (ASD)United States
-
Adia Med of Winter Park LLCRecruitingAutism Spectrum Disorder | Autism | ASD | Autism Spectrum Disorder (ASD)United States
-
Stanford UniversityJohn and Marcia Goldman FoundationNot yet recruitingAutism | Autism Spectrum Disorder (ASD)United States
-
Father Flanagan's Boys' HomeNational Institute on Deafness and Other Communication Disorders (NIDCD)Not yet recruitingAutism Spectrum Disorder | Autism | Autism, Susceptibility to, 6United States
Clinical Trials on music therapy, speech therapy
-
Iran University of Medical SciencesCompletedParkinson Disease | Speech Disorders | Voice DisordersIran, Islamic Republic of
-
Assistance Publique Hopitaux De MarseilleRecruitingEpilepsy | Temporal Lobe Epilepsy | AnomiaFrance
-
Ewha Womans University Seoul HospitalEwha Womans University Mokdong Hospital; National Rehabilitation Center, Seoul...CompletedDysarthria As Late Effect of StrokeKorea, Republic of
-
Klinik ArlesheimUniversity of Bern; Paracelsus-Spital RichterswilCompletedHypertension
-
Riphah International UniversityCompletedAutism Spectrum DisorderPakistan
-
Hospital de Clinicas de Porto AlegreCompletedOral Cancer | Intelligibility, Speech | Tongue Cancer | Jaw CancerBrazil
-
Johns Hopkins UniversityWithdrawn
-
Ewha Womans University Seoul HospitalEwha Womans University Mokdong Hospital; National Rehabilitation Center, Seoul...Not yet recruitingDysarthria As Late Effect of Stroke
-
Medical University of WarsawCompleted
-
Johns Hopkins UniversityCompletedPrimary Progressive Aphasia | PPAUnited States