Pediatric Massage for Children With Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title: The Effectiveness and Brain-related Mechanism of Pediatric Massage for Children With Autism Spectrum Disorder (ASD): A Randomized, Waiting-list Controlled Trial

Status Recruiting

Clinical 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, 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

• NCT number: NCT04220086
• Study type: Interventional
• Source: The University of Hong Kong
• Contact: Xin-Jing Yang
• Phone: +852 39176471
• Email: yangxj@hku.hk
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2021
• Completion date: December 31, 2022