- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06277778
Effect of Combined Music and Taekwondo Training for Children With Autism Spectrum Disorder
February 18, 2024 updated by: The Hong Kong Polytechnic University
Effect of Combined Music and Taekwondo Training on the Psychological and Physical Condition of Children With Autism Spectrum Disorder: A Randomized Controlled Trial
The goal of this randomized controlled trial is to evaluate the effect of combined music and taekwondo training on the mental and physical condition of children with autism spectrum disorder.
Participants will be asked to do combined music and taekwondo training or taekwondo training alone to evaluate if the combined training is better than the taekwondo training alone on mental and physical performance for children with autism spectrum disorder.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clare CW YU, PhD
- Phone Number: +85234003251
- Email: clare-chung-wah.yu@polyu.edu.hk
Study Contact Backup
- Name: Kam-Ming Mok, PhD
- Email: kmmok2@ln.edu.hk
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Chinese children aged 7 to 9 years who have been clinically diagnosed as ASD by developmental paediatricians or clinical psychologists based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for ASD.
Exclusion Criteria:
- children who have experience in Taekwondo training;
- children who have received music therapy within the previous 12 months;
- those who have severe sensory disorders (blindness or deafness);
- those who have underlying congenital abnormalities or other diseases that limit their ability to engage in physical activities.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Taekwondo training with music therapy
the participating children will attend 20 sessions of Taekwondo training with the presence of music.
|
Taekwondo training with music therapy
|
Sham Comparator: Taekwondo training alone
the participating children will attend 20 sessions of Taekwondo training alone.
|
Taekwondo training without music therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Engagement in the Training Sessions
Time Frame: Through training completion, an average of 20 sessions over 10 consecutive weeks
|
the Revised Individual Child Engagement Record (ICER); The ICER-R uses a 15-second momentary time sampling approach and involves the coding of types of engagement, the occurrence of interaction and the interaction partner (coach or peers), and whether the child was physically prompted.
The types of engagement being coded at each 15-second interval are active engagement, passive engagement, active non-engagement, and passive non-engagement.
|
Through training completion, an average of 20 sessions over 10 consecutive weeks
|
Gross Motor Skills
Time Frame: Baseline, 10 weeks
|
Motor skills will be assessed using the Bruininks-Oseretsky Test of Motor Proficiency-2
|
Baseline, 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Activity Level
Time Frame: Through training completion, an average of 20 sessions over 10 consecutive weeks
|
Participants will wear an optical heart rate monitor on their forearm to measure their exercise heart rate as a reflection of the physical activity level during the training.
Continuous heart rate data will be recorded for every record and expressed as the mean heart rate per min.
|
Through training completion, an average of 20 sessions over 10 consecutive weeks
|
Enjoyment State
Time Frame: Through training completion, an average of 20 sessions over 10 consecutive weeks
|
The Children's Emotional Manifestation Scale (CEMS) will be used to assess the children's emotional state.
It classifies observable emotional behaviours into five categories: 'Facial expression', 'Vocalization', 'Activity', 'Interaction', and 'Level of cooperation'.
Each category is scored from 1 to 5. The numbers obtained for each category are added together to obtain the total score, which will be between 5 and 25.
High scores indicate the manifestation of more negative emotional behavior.
|
Through training completion, an average of 20 sessions over 10 consecutive weeks
|
Rate of Perceived Exertion
Time Frame: Through training completion, an average of 20 sessions over 10 consecutive weeks
|
Children will be asked to rate their exertion level using the Borg 6-to-20 Scale, in which "6" indicates "no exertion at all" and "20" indicates "maximal exertion".
|
Through training completion, an average of 20 sessions over 10 consecutive weeks
|
Taekwondo skills performance
Time Frame: Baseline, 10 weeks
|
A scoring system was modified for use in this project with reference to the international Taekwondo referee scoring standard.
Children's performance for a set of selected Taekwondo moves and kicks will be observed and scored by two qualified referees.
The performance will be scored out of 8 marks, with 3 marks for presentation, 2 marks for cognitive ability, 2 marks for basic skills, and 1 mark for social interaction.
Higher scores indicate better performance.
|
Baseline, 10 weeks
|
Conners' Continuous Performance Test II
Time Frame: Baseline, 10 weeks
|
This test will be used to measure the children's selective attention, that is, their ability to maintain a consistent focus on some continuous stimuli.
|
Baseline, 10 weeks
|
Comprehensive Trail-Making Test (CTMT)
Time Frame: Baseline, 10 weeks
|
The test consists of five visual search and sequencing tasks that are heavily influenced by attention, concentration, resistance to distraction, and cognitive flexibility (or set-shifting).
The child is required to connect a series of stimuli (numbers, expressed as numerals or in word form, and letters) in a specified order as fast as possible in each trial.
The time scores for the five CTMT trials will be converted to standardized T-scores according to the reference tables in the testing manual, and be summed up to produce a global performance level score, the CTMT Composite Index (CI), which can then be converted into a percentile score according to the participant's chronological age.
Higher T score and CTMT CI correspond to better performance.
|
Baseline, 10 weeks
|
Social Responsiveness Scale, second edition (SRS-2)
Time Frame: Baseline, 10 weeks
|
This scale will be completed by the parents.
It is a 65-item autism rating scale widely use to identify a spectrum of deficits in reciprocal social behavior, ranging from absent to severe, based on observations of a child's behavior in various social settings.
Scoring is on a four-point Likert Scale with five subscales (social awareness, social cognition, social communication, social motivation, and autistic mannerism).
Higher T-scores correspond to poorer social functioning.
|
Baseline, 10 weeks
|
Childhood Autism Spectrum Test
Time Frame: Baseline, 10 weeks
|
This is a 39-item, yes-or-no questionnaire of children's social behavior and communication tendencies as reported by their parents.
The questionnaire has been translated into Chinese and is being validated.
The cut-off score of 15 marks indicates possible autism spectrum disorder (ASD) or related social-communication difficulties.
|
Baseline, 10 weeks
|
Strength and Difficulties Questionnaires (SDQ)
Time Frame: Baseline, 10 weeks
|
The questionnaire will be completed by parents.
There are 25 items in the SDQ, which consists of five scales, each with five items, for assessing children's mental health status in terms of emotional, conduct, hyperactivity, peer problems, and prosocial behavior.
|
Baseline, 10 weeks
|
Clinical Global Improvement (CGI) score
Time Frame: 10 weeks, 2 months follow-up
|
The CGI-I will be completed by parents to evaluate children's functional changes in daily life after completion of the 10-week program, and at 2-month follow-up.
The CGI-I consisted of 12 questions developed by our research team, which are focused on all core symptoms of ASD and covered the following aspects: (1) motor functioning; (2) children's capability to follow instructions; (3) social, communication, and language understanding and expression; and (4) children's capabilities for attention shifting, attention to complete a task, attention to details, and imagination.
|
10 weeks, 2 months follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Clare CW YU, PhD, Assistant Professor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
January 14, 2024
First Submitted That Met QC Criteria
February 18, 2024
First Posted (Actual)
February 26, 2024
Study Record Updates
Last Update Posted (Actual)
February 26, 2024
Last Update Submitted That Met QC Criteria
February 18, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20211117003-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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