Clinical trial NCT04220086: Pediatric Massage for Children With Autism Spectrum Disorder
Official title: The Effectiveness and Brain-related Mechanism of Pediatric Massage for Children With Autism Spectrum Disorder (ASD): A Randomized, Waiting-list Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Shenzhen Children's Hospital
First posted: 2020-01-07
Enrollment: 87
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in the Autism Behavior Checklist (ABC)
timeFrame: Baseline, 4 week, 8 week, 12 week, and follow-up assessment at the week of 4, 8, 12 after treatment
Secondary outcomes:
measure: Changes in the Childhood Autism Rating Scale (CARS)
timeFrame: Baseline, 4 week, 8 week, 12 week
measure: Changes in the Social Responsiveness Scale - Second Edition (SRS-2)
timeFrame: Baseline, 4 week, 8 week, 12 week
measure: Changes in the Children's Sleep Habits Questionnaire (CSHQ)
timeFrame: Baseline, 4 week, 8 week, 12 week
measure: Changes in the Eysenck Personality Questionnaire (EPQ) - adult version
timeFrame: Baseline
measure: Changes in electroencephalography (EEG)
timeFrame: Baseline, 12 week
measure: Changes in functional near-infrared spectroscopy (fNIRS) of the brain
timeFrame: Baseline, 12 week
measure: Number of participants with non-serious and serious adverse events (AEs)
timeFrame: 1,2,3,4,5,6,7,8,9,10,11,12 weeks
measure: Number of participants with abnormal laboratory values in blood routine examination.
timeFrame: Baseline, 12 week
measure: Changes in the Autism Treatment Evaluation Checklist (ATEC).
timeFrame: Baseline, 4 week, 8 week, 12 week
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Children's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Department of Chinese Medicine, The University of Hong Kong-Shenzhen Hospital
state: Guangdong
Study officials:
affiliation: The University of Hong Kong-Shenzhen Hospital
name: Zhang-Jin Zhang
role: PRINCIPAL_INVESTIGATOR
References: