Back to resultsPediatric Massage for Children With Autism Spectrum Disorder
Primary Purpose
Autism Spectrum Disorder
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pediatric massage therapy
Usual care
No intervention
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Shenzhen Children's HospitalRecruiting
- Department of Chinese Medicine, The University of Hong Kong-Shenzhen HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Other
Arm Label
Pediatric massage
Waitlist control
Healthy Control
Arm Description
Children with ASD will receive pediatric massage for 12 weeks.
Waitlist control
15 healthy controls (age- and sex- matched with ASD patients) will be recruited. All of them will receive clinical evaluations, EEG and fNIRS detection.
Outcomes
Primary Outcome Measures
Changes in the Autism Behavior Checklist (ABC)
ABC is a scale used for nonadaptive behaviors created to screen and indicate the probability of a diagnosis of autism. The questionnaire including 57 items related to five areas: sensorial, relational, use of body and objects, and social skills. Scale score> 67 strongly suggests the presence of autism. Changes in the ABC from baseline to endpoint will be observed. Assessments will be conducted at baseline and once every four weeks thereafter.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04220086
First Posted
October 27, 2019
Last Updated
September 27, 2021
Sponsor
The University of Hong Kong
Collaborators
Shenzhen Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04220086
Brief Title
Pediatric Massage for Children With Autism Spectrum Disorder
Official Title
The Effectiveness and Brain-related Mechanism of Pediatric Massage for Children With Autism Spectrum Disorder (ASD): A Randomized, Waiting-list Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 30, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Shenzhen Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
87 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pediatric massage
Arm Type
Experimental
Arm Description
Children with ASD will receive pediatric massage for 12 weeks.
Arm Title
Waitlist control
Arm Type
Sham Comparator
Arm Description
Waitlist control
Arm Title
Healthy Control
Arm Type
Other
Arm Description
15 healthy controls (age- and sex- matched with ASD patients) will be recruited. All of them will receive clinical evaluations, EEG and fNIRS detection.
Intervention Type
Procedure
Intervention Name(s)
Pediatric massage therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Usual care
Intervention Description
Including Applied Behavior Analysis (ABA), Educational intervention, Interpersonal development intervention.
Intervention Type
Other
Intervention Name(s)
No intervention
Other Intervention Name(s)
No intervention for healthy controls
Intervention Description
No intervention for healthy controls
Primary Outcome Measure Information:
Title
Changes in the Autism Behavior Checklist (ABC)
Description
ABC is a scale used for nonadaptive behaviors created to screen and indicate the probability of a diagnosis of autism. The questionnaire including 57 items related to five areas: sensorial, relational, use of body and objects, and social skills. Scale score> 67 strongly suggests the presence of autism. Changes in the ABC from baseline to endpoint will be observed. Assessments will be conducted at baseline and once every four weeks thereafter.
Time Frame
Baseline, 4 week, 8 week, 12 week, and follow-up assessment at the week of 4, 8, 12 after treatment
Secondary Outcome Measure Information:
Title
Changes in the Childhood Autism Rating Scale (CARS)
Description
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.
Time Frame
Baseline, 4 week, 8 week, 12 week
Title
Changes in the Social Responsiveness Scale - Second Edition (SRS-2)
Description
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.
Time Frame
Baseline, 4 week, 8 week, 12 week
Title
Changes in the Children's Sleep Habits Questionnaire (CSHQ)
Description
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.
Time Frame
Baseline, 4 week, 8 week, 12 week
Title
Changes in the Eysenck Personality Questionnaire (EPQ) - adult version
Description
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.
Time Frame
Baseline
Title
Changes in electroencephalography (EEG)
Description
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.
Time Frame
Baseline, 12 week
Title
Changes in functional near-infrared spectroscopy (fNIRS) of the brain
Description
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.
Time Frame
Baseline, 12 week
Title
Number of participants with non-serious and serious adverse events (AEs)
Description
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.
Time Frame
1,2,3,4,5,6,7,8,9,10,11,12 weeks
Title
Number of participants with abnormal laboratory values in blood routine examination.
Description
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.
Time Frame
Baseline, 12 week
Title
Changes in the Autism Treatment Evaluation Checklist (ATEC).
Description
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.
Time Frame
Baseline, 4 week, 8 week, 12 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin-Jing Yang
Phone
+852 39176471
Email
yangxj@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang-Jin Zhang
Organizational Affiliation
The University of Hong Kong-Shenzhen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shenzhen Children's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cong KOU
Phone
+86 18923838509
Email
koucong1982@163.com
First Name & Middle Initial & Last Name & Degree
Cong KOU
Facility Name
Department of Chinese Medicine, The University of Hong Kong-Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shui-Yan ZHANG
Phone
+86 13826569649
Email
zhangsy9@hku-szh.org
First Name & Middle Initial & Last Name & Degree
Zhang-Jin ZHANG
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pediatric Massage for Children With Autism Spectrum Disorder
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