Pediatric Massage for Children With Autism Spectrum Disorder

The University of Hong Kong (HKU)

Status: Unknown

Conditions: Autism Spectrum Disorder

Treatments: Procedure: Pediatric massage therapy; Other: No intervention; Procedure: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04220086

TNASD1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 87 estimated patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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;
2. Aged 3-10, right-handedness ；
3. The parents (or other legal guardians) of participants to give consent and to cooperate with the treatment and data collection.

Exclusion criteria

1. The conventional treatment accepted currently does not belong to the following three categories: Applied Behavior Analysis (ABA), Educational intervention or Interpersonal development intervention;
2. Patients with any major treatment changes within 4 weeks prior to joining the study;
3. 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);
4. Seizure within the last year prior to enrolment, or the need for seizure medications either at present or in the past;
5. Being involved in other clinical trials;
6. Patients received pediatric massage therapy in the past two months, or are receiving pediatric massage;
7. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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87 participants in 3 patient groups

Pediatric massage

Experimental group

Description:

Children with ASD will receive pediatric massage for 12 weeks.

Treatment:

Procedure: Usual care

Procedure: Pediatric massage therapy

Waitlist control

Sham Comparator group

Description:

Waitlist control

Treatment:

Procedure: Usual care

Healthy Control

Other group

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.

Treatment:

Other: No intervention