NCT04220086

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
1.4 years until next milestone

Study Start

First participant enrolled

May 30, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

1.1 years

First QC Date

October 27, 2019

Last Update Submit

September 27, 2021

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 4 week, 8 week, 12 week, and follow-up assessment at the week of 4, 8, 12 after treatment

Secondary Outcomes (9)

  • Changes in the Childhood Autism Rating Scale (CARS)

    Baseline, 4 week, 8 week, 12 week

  • Changes in the Social Responsiveness Scale - Second Edition (SRS-2)

    Baseline, 4 week, 8 week, 12 week

  • Changes in the Children's Sleep Habits Questionnaire (CSHQ)

    Baseline, 4 week, 8 week, 12 week

  • Changes in the Eysenck Personality Questionnaire (EPQ) - adult version

    Baseline

  • Changes in electroencephalography (EEG)

    Baseline, 12 week

  • +4 more secondary outcomes

Study Arms (3)

Pediatric massage

EXPERIMENTAL

Children with ASD will receive pediatric massage for 12 weeks.

Procedure: Pediatric massage therapyProcedure: Usual care

Waitlist control

SHAM COMPARATOR

Waitlist control

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.

Other: No intervention

Interventions

Pediatric massage therapyPROCEDURE

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.

Pediatric massage
Usual carePROCEDURE

Including Applied Behavior Analysis (ABA), Educational intervention, Interpersonal development intervention.

Pediatric massageWaitlist control
No interventionOTHER

No intervention for healthy controls

Also known as: No intervention for healthy controls
Healthy Control

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shenzhen Children's Hospital

Shenzhen, Guangdong, 518038, China

RECRUITING

Department of Chinese Medicine, The University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, 518053, China

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Zhang-Jin Zhang

    The University of Hong Kong-Shenzhen Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin-Jing Yang

CONTACT

+852 39176471yangxj@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 27, 2019

First Posted

January 7, 2020

Study Start

May 30, 2021

Primary Completion

June 30, 2022

Study Completion

December 31, 2022

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations

CN(2)