Pediatric Massage for Children With Autism Spectrum Disorder

Last updated: September 27, 2021
Sponsor: The University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autism Spectrum Disorder (Asd)

Williams Syndrome

Asperger's Disorder

Treatment

N/A

Clinical Study ID

NCT04220086
TNASD1
  • Ages 3-10
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Autism Spectrum Disorder (ASD) has been diagnosed and a diagnosis certificate has beenprovided. The diagnostic criteria is based on the Diagnostic and Statistical Manual ofMental Disorders fifth version (DSM-V) criteria of Autism Spectrum Disorder. Score ofCARS≥30;
  2. Aged 3-10, right-handedness ;
  3. The parents (or other legal guardians) of participants to give consent and tocooperate with the treatment and data collection.

Exclusion

Exclusion Criteria:

  1. The conventional treatment accepted currently does not belong to the following threecategories: Applied Behavior Analysis (ABA), Educational intervention or Interpersonaldevelopment 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 psychiatricdiseases, genetic disease, or other severe systemic disease (such as history of severehead trauma, or stroke);
  4. Seizure within the last year prior to enrolment, or the need for seizure medicationseither 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 receivingpediatric massage;
  7. During the study period, parents will be required not to initiate any newinterventions or modify current interventions unless absolutely necessary. If a changemust be made, the parent is required to inform investigator, who decides whether thesubject should stop participating in the study based on situation.

Study Design

Total Participants: 87
Study Start date:
May 30, 2021
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

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

    Shenzhen, Guangdong 518053
    China

    Active - Recruiting

  • Shenzhen Children's Hospital

    Shenzhen, Guangdong 518038
    China

    Active - Recruiting

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