Autism Spectrum DisorderNCT04220086
Pediatric Massage for Children With Autism Spectrum Disorder
A study testing Pediatric massage therapy in people with Autism Spectrum Disorder, run by The University of Hong Kong at 2 sites in China.
Trial summary
This study was designed as a randomized controlled clinical trial of pediatric massage for children with Autism Spectrum Disorder (ASD). 72 ASD children will be recruited and randomly divided into two groups: the treatment group (pediatric massage + usual care, n=36) and the control group (usual care/waitlist group… Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Pediatric massage therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 2 sitesChina
- Study dates
- 30 May 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Autism Spectrum Disorder (ASD) has been diagnosed and a diagnosis certificate has been provided. The diagnostic criteria is based on the Diagnostic and Statistical Manual of Mental Disorders fifth version (DSM-V) criteria of Autism Spectrum Disorder. Score of CARS≥30;
- Aged 3-10, right-handedness ；
- The parents (or other legal guardians) of participants to give consent and to cooperate with the treatment and data collection.
Who cannot join
- The conventional treatment accepted currently does not belong to the following three categories: Applied Behavior Analysis (ABA), Educational intervention or Interpersonal development intervention;
- Patients with any major treatment changes within 4 weeks prior to joining the study;
- Patients or their parents with other neurodevelopmental disorders, severe psychiatric diseases, genetic disease, or other severe systemic disease (such as history of severe head trauma, or stroke);
- Seizure within the last year prior to enrolment, or the need for seizure medications either at present or in the past;
- Being involved in other clinical trials;
- Patients received pediatric massage therapy in the past two months, or are receiving pediatric massage;
- During the study period, parents will be required not to initiate any new interventions or modify current interventions unless absolutely necessary. If a change must be made, the parent is required to inform investigator, who decides whether the subject should stop participating in the study based on situation.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shenzhen Children's Hospital
Shenzhen, Guangdong, 518038
Department of Chinese Medicine, The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, 518053
About this study
Official title: The Effectiveness and Brain-related Mechanism of Pediatric Massage for Children With Autism Spectrum Disorder (ASD): A Randomized, Waiting-list Controlled Trial
This study was designed as a randomized controlled clinical trial of pediatric massage for children with Autism Spectrum Disorder (ASD). 72 ASD children will be recruited and randomly divided into two groups: the treatment group (pediatric massage + usual care, n=36) and the control group (usual care/waitlist group, n=36).30 healty controls will be recruited. Children in the treatment group will received 12 weeks pediatric massage by doctors and their own parents.
The Autism Behavior Checklist (ABC), Childhood Autism Rating Scale (CARS), Autism Treatment Evaluation Checklist (ATEC), Social Responsiveness Scale-Second Edition (SRS-2), Children's Sleep Habits Questionnaire (CSHQ) and Eysenck Personality Questionnaire (EPQ) will be used to assess the clinical behavioral changes of all participants, and to analyze the clinical effectiveness and safety of pediatric massage for children with ASD.
Electroencephalography (EEG) and brain functional near-infrared spectroscopy (fNIRS) will be recorded before and after treatment, to observe the potential brain target of pediatric massage for children with ASD.
Read the detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by deficits in social interactions and communication skills, both verbal and non-verbal, restricted interests, and stereotypical behaviors. However, at present, there is no drug has proven effective in alleviating the core symptoms of social and communication difficulties in ASD.
ASD families are becoming turn to complementary and alternative medicine (CAM). They use CAM to treat symptoms of autism in general, comorbid symptoms (such as attention, hyperactivity, irritability, moodiness, gastrointestinal symptoms, seizures, sleep and tactile sensitivity). In addition, some families report that the use of CAM has less negative side effects compared with conventional treatments.
As a traditional TCM therapy, pediatric massage has been used in treating various pediatric diseases including ASD. A large number of clinical studies have shown that pediatric massage can improve ASD and its accompanied symptoms effectively. However, its exact effectiveness and mechanism need to be further explored.
In the proposed study, pediatric massage will be employed to treat children with ASD, to confirm the effectiveness and safety of pediatric massage therapy for children with ASD, and to explore the potential mechanism and target of pediatric massage for ASD.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Pediatric massage therapy, Usual care, No intervention
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric massage therapyProcedure or surgery
Children with ASD will receive pediatric massage therapy twice a week for 12 consecutive weeks by professional pediatric massage doctor. In addition, they will receive parent provided pediatric massage therapy at home after their parents received the professional pediatric massage therapy training. The frequency of pediatric massage will not be more than once every day and each session last about 30 minutes.
Usual careProcedure or surgery
Including Applied Behavior Analysis (ABA), Educational intervention, Interpersonal development intervention.
No interventionOther
Also called No intervention for healthy controls
No intervention for healthy controls
| Study group | Role | What they receive |
|---|---|---|
| Pediatric massage | Experimental | Children with ASD will receive pediatric massage for 12 weeks. Receives: Procedure: Pediatric massage therapy; Procedure: Usual care |
| Waitlist control | Sham comparator | Waitlist control Receives: Procedure: Usual care |
| Healthy Control | Other | 15 healthy controls (age- and sex- matched with ASD patients) will be recruited. All of them will receive clinical evaluations, EEG and fNIRS detection. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Autism Treatment Evaluation Checklist (ATEC)
The ATEC is designed to be completed by parents, teachers, or caretakers. It consists of 4 subtests: I. Speech/Language Communication (14 items); II. Sociability (20 items); III. Sensory/ Cognitive Awareness (18 items); and IV. Health/Physical/Behavior (25 items). It basically provides several subscale scores as well as a total score to be used for comparison before and after treatment.
Measured: Baseline, 4 week, 8 week, 12 week
Secondary outcomes (8)
Changes in the Childhood Autism Rating Scale (CARS)
CARS assesses the child on a scale from 1 to 4 in each of 15 dimensions or symptoms (including the ability to relate to people, emotional response, imitation, body use, object use, listening response, fear or nervousness, verbal communication, nonverbal communication, activity level, level and reliability of intellectual response, adaptation to changes, visual response, taste, smell and touch responses and general impressions). A total score of at least 30 strongly suggests the presence of autism. Children with score between 30 and 36 have mild-to-moderate autism while those with score between 37 and 60 have severe autism. Change in CARS from Baseline to Endpoint will be observed. Assessments will be conducted at baseline and once every four weeks thereafter.
Measured: Baseline, 4 week, 8 week, 12 week
Changes in the Social Responsiveness Scale - Second Edition (SRS-2)
The Social Responsiveness Scale is a parent- and/or teacher-reported 65 question scale designed to measure social competence. Each question on the scale inquires about an observed aspect of reciprocal social behavior that is rated from "0" to "3", where 0 is best possible behavior and 3 is the worst possible behavior. The total SRS score may range from 0 to 195 where higher values represent the worse outcome. Assessments will be conducted at baseline and once every four weeks thereafter.
Measured: Baseline, 4 week, 8 week, 12 week
Changes in the Children's Sleep Habits Questionnaire (CSHQ)
The Children's Sleep Habits Questionnaire (CSHQ) is a parental report sleep screening instrument designed for preschool- and school-aged children. The scale yields both a total score and 8 subscales reflecting the following sleep domains:1) bedtime resistance, 2) sleep onset delay, 3) sleep duration, 4) sleep anxiety, 5) night wakings, 6) parasomnias, 7) sleep-disordered breathing, 8) daytime sleepiness. Each item is answered with 1 of 3 markers: "usually" for 5 or more times a week, "sometimes" for 2-4 times a week, and "rarely" for never or 1 time a week. Higher scores reflect more disturbed sleep behavior. Assessments will be conducted at baseline and once every four weeks thereafter.
Measured: Baseline, 4 week, 8 week, 12 week
Changes in the Eysenck Personality Questionnaire (EPQ) - adult version
The EPQ is a three dimensional personality assessment tool to assess the personality traits of a person, including the Psychoticism (P), Extraversion (E), Neuroticism (N), and Lie (L) scales. Assessments will be conducted at baseline for parents to access parents' personality.
Measured: Baseline
Changes in functional near-infrared spectroscopy (fNIRS) of the brain
Functional near-infrared spectroscopy (fNIRS) is a non-invasive neuroimaging procedure used to measure hemodynamic changes (oxyhemoglobin, deoxyhemoglobin and total haemoglobin), it will be measured at baseline and after the12-week treatment.
Measured: Baseline, 12 week
Number of participants with non-serious and serious adverse events (AEs)
Safety assessment. Adverse events that are related to treatment will be recorded once AE happens throughout the whole study. Adverse events rate will be assessed in all patients.
Measured: 1,2,3,4,5,6,7,8,9,10,11,12 weeks
Changes in electroencephalography (EEG)
EEG is a useful indicator of cortical connectivity between functional areas in the brain. Continuous resting-state electroencephalography (EEG) was recorded before and after the 12-week treatment and the delta (δ), theta (θ), alpha (α), beta (β) and gamma (γ) bands frequency will be used for EEG analysis.
Measured: Baseline, 12 week
Number of participants with abnormal laboratory values in blood routine examination.
Safety assessment. Blood routine examination (including RBC, WBC, Hb, HCT, PLT, MCV, MCH, MCHC, W-SCR, W-LCR, W-SCC, W-LCC, RDW-CV, PDW, and MPV levels) will be conducted before and after treatment to evaluate if there is infection or anemia. Number of participants with abnormal laboratory values will be recorded.
Measured: Baseline, 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2020
- Study start30 May 2021
- Primary completion30 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Children's Hospital
- Responsible party
- Principal investigator, Prof. Zhang Zhang-Jin, The University of Hong Kong
- Investigators
- Zhang-Jin Zhang, Principal investigator, The University of Hong Kong-Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04220086
- Sponsor's protocol ID
- TNASD1
- Status last verified
- Aug 2026
- First submitted
- 27 Oct 2019
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness and Brain-related Mechanism of Pediatric Massage for Children With Autism Spectrum Disorder (ASD): A Randomized, Waiting-list Controlled Trial
- ClinicalTrials.gov ID
- NCT04220086
- Acronym / sponsor ID
- TNASD1
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Shenzhen Children's Hospital
- Study start
- 30 May 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 7 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed as a randomized controlled clinical trial of pediatric massage for children with Autism Spectrum Disorder (ASD). 72 ASD children will be recruited and randomly divided into two groups: the treatment group (pediatric massage + usual care, n=36) and the control group (usual care/waitlist group, n=36).30 healty controls will be recruited. Children in the treatment group will received 12 weeks pediatric massage by doctors and their own parents.
The Autism Behavior Checklist (ABC), Childhood Autism Rating Scale (CARS), Autism Treatment Evaluation Checklist (ATEC), Social Responsiveness Scale-Second Edition (SRS-2), Children's Sleep Habits Questionnaire (CSHQ) and Eysenck Personality Questionnaire (EPQ) will be used to assess the clinical behavioral changes of all participants, and to analyze the clinical effectiveness and safety of pediatric massage for children with ASD.
Electroencephalography (EEG) and brain functional near-infrared spectroscopy (fNIRS) will be recorded before and after treatment, to observe the potential brain target of pediatric massage for children with ASD.
Detailed description
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by deficits in social interactions and communication skills, both verbal and non-verbal, restricted interests, and stereotypical behaviors. However, at present, there is no drug has proven effective in alleviating the core symptoms of social and communication difficulties in ASD.
ASD families are becoming turn to complementary and alternative medicine (CAM). They use CAM to treat symptoms of autism in general, comorbid symptoms (such as attention, hyperactivity, irritability, moodiness, gastrointestinal symptoms, seizures, sleep and tactile sensitivity). In addition, some families report that the use of CAM has less negative side effects compared with conventional treatments.
As a traditional TCM therapy, pediatric massage has been used in treating various pediatric diseases including ASD. A large number of clinical studies have shown that pediatric massage can improve ASD and its accompanied symptoms effectively. However, its exact effectiveness and mechanism need to be further explored.
In the proposed study, pediatric massage will be employed to treat children with ASD, to confirm the effectiveness and safety of pediatric massage therapy for children with ASD, and to explore the potential mechanism and target of pediatric massage for ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pediatric massage | Experimental | Procedure: Pediatric massage therapy, Procedure: Usual careChildren with ASD will receive pediatric massage for 12 weeks. |
| Waitlist control | Sham comparator | Procedure: Usual careWaitlist control |
| Healthy Control | Other | Other: No intervention15 healthy controls (age- and sex- matched with ASD patients) will be recruited. All of them will receive clinical evaluations, EEG and fNIRS detection. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Autism Spectrum Disorder (ASD) has been diagnosed and a diagnosis certificate has been provided. The diagnostic criteria is based on the Diagnostic and Statistical Manual of Mental Disorders fifth version (DSM-V) criteria of Autism Spectrum Disorder. Score of CARS≥30;
- Aged 3-10, right-handedness ；
- The parents (or other legal guardians) of participants to give consent and to cooperate with the treatment and data collection.
Key exclusion criteria (7 listed)
- The conventional treatment accepted currently does not belong to the following three categories: Applied Behavior Analysis (ABA), Educational intervention or Interpersonal development intervention;
- Patients with any major treatment changes within 4 weeks prior to joining the study;
- Patients or their parents with other neurodevelopmental disorders, severe psychiatric diseases, genetic disease, or other severe systemic disease (such as history of severe head trauma, or stroke);
- Seizure within the last year prior to enrolment, or the need for seizure medications either at present or in the past;
- Being involved in other clinical trials;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pediatric massage therapyChildren with ASD will receive pediatric massage therapy twice a week for 12 consecutive weeks by professional pediatric massage doctor. In addition, they will receive parent provided pediatric massage therapy at home after their parents received the professional pediatric massage therapy training. The frequency of pediatric massage will not be more than once every day and each session last about 30 minutes. | Procedure or surgery | Pediatric massage |
| Usual careIncluding Applied Behavior Analysis (ABA), Educational intervention, Interpersonal development intervention. | Procedure or surgery | Pediatric massage, Waitlist control |
| No interventionAlso: No intervention for healthy controlsNo intervention for healthy controls | Other | Healthy Control |
Primary outcome
Changes in the Autism Treatment Evaluation Checklist (ATEC)
Time frame: Baseline, 4 week, 8 week, 12 week
The ATEC is designed to be completed by parents, teachers, or caretakers. It consists of 4 subtests: I. Speech/Language Communication (14 items); II. Sociability (20 items); III. Sensory/ Cognitive Awareness (18 items); and IV. Health/Physical/Behavior (25 items). It basically provides several subscale scores as well as a total score to be used for comparison before and after treatment.
8 secondary outcomes
Changes in the Childhood Autism Rating Scale (CARS)
Time frame: Baseline, 4 week, 8 week, 12 week
Changes in the Social Responsiveness Scale - Second Edition (SRS-2)
Time frame: Baseline, 4 week, 8 week, 12 week
Changes in the Children's Sleep Habits Questionnaire (CSHQ)
Time frame: Baseline, 4 week, 8 week, 12 week
Changes in the Eysenck Personality Questionnaire (EPQ) - adult version
Time frame: Baseline
Changes in functional near-infrared spectroscopy (fNIRS) of the brain
Time frame: Baseline, 12 week
Number of participants with non-serious and serious adverse events (AEs)
Time frame: 1,2,3,4,5,6,7,8,9,10,11,12 weeks
Changes in electroencephalography (EEG)
Time frame: Baseline, 12 week
Number of participants with abnormal laboratory values in blood routine examination.
Time frame: Baseline, 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang-Jin Zhang principal investigator
The University of Hong Kong-Shenzhen Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric massage therapy in people with Autism Spectrum Disorder, run by The University of Hong Kong at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Autism Treatment Evaluation Checklist (ATEC) (time frame: Baseline, 4 week, 8 week, 12 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.