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Pediatric Massage for Children With Autism Spectrum Disorder

NCT04220086 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2021-09-29

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Pediatric massage therapy

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.

PROCEDURE

Usual care

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

OTHER

No intervention

No intervention for healthy controls

Sponsors & Collaborators

  • Shenzhen Children's Hospital

    collaborator OTHER_GOV

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Zhang-Jin Zhang · The University of Hong Kong-Shenzhen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-30
Primary Completion
2022-06-30
Completion
2022-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04220086 on ClinicalTrials.gov