The investigators hypothesize that electromagnetic therapy (EMT) could produce greater improvement on Autism spectrum disorder (ASD) compared to the waitlist control. To test this hypothesis, a pilot randomized waitlist-controlled trial is designed to achieve the 2 aims: 1. To evaluate the efficacy of EMT in improving children with ASD as measured by Childhood Autism Rating Scale (CARS) by comparing the change in CARS scores from baseline to week 12 between the two groups. 2. To assess the safety of EMT by comparing the number of participants with adverse events, number of participants withdrawn and reasons of withdrawal in treatment group with those in the control group. A pilot randomized waitlist-controlled trial is designed. A total of 30 children aged 3-12 years with a principal diagnosis of ASD will be recruited. They will be randomly assigned to Care-As Usual (CAU) and CAU+EMT groups (n = 15 each group). Participants on the CAU+EMT group will receive a total of 30 sessions of EMT within 12 weeks (2 - 3 sessions/week).Those who are initially assigned to CAU group will receive EMT for 12 weeks after they complete the trial. The post-trial treatment will serve as a compensation for their participation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Electromagnetic therapy will be performed using an electromagnetic stimulator (Smart Cap). Chinese medicine practitioners who have at least 3 years of experience will conduct EMT after training. Each session of EMT will take 20-25 min, with 2-3 sessions per week, total of 30 sessions finished within 12 weeks.
Clinical Services Centres, The School of Chinese Medicine, The University of Hong Kong
Hong Kong, Hong Kong
Childhood Autism Rating Scale（CARS）
CARS consists of 15 items that cover all domains of ASD symptoms: 1, relationship to people; 2, Imitation; 3, emotional response; 4, body use; 5, object use; 6, adaptation to change; 7, visual response; 8, listening response; 9, taste-smell-touch response and use; 10, fear and nervousness; 11, verbal communication; 12. non-verbal communication; 13. Activity level; 14. Level and consistency of intellectual response; 15, general impressions. Each item is scored from "1" (normal behavior) to "4" (severely abnormal behavior), with a total score ranging from 15 to 60. Scores 30-37 indicate mild to moderate ASD; 38-60 indicate severe.
Time frame: The changes from baseline to week 12, week 24 and week 36.
Autism Treatment Evaluation Scale (ATEC)
Autism Treatment Evaluation Scale is evaluated by a parent and serve as supplementary to CARS.The minimum vale of ATEC is 0 and the maximum value is 197, the higher the score the worse the outcome.
Time frame: The changes from baseline, week 12, week 24 and week 36.
Children's Sleep Habits Questionnaire (CSHQ)
The minimum vale of CSHQ is 0 and the maximum value is 66, the higher the score the worse the outcome.
Time frame: The changes from baseline, week 12, week 24 and week 36.
Clinical Global Impression-Severity (CGI-S)
The minimum vale of CGI-S is 0 and the maximum value is 7, the higher the score the worse the outcome.
Time frame: The changes from baseline, week 12, week 24 and week 36.
Clinical Global Impression Severity-Improvement (CGI-I)
The minimum vale of CGI-I is 0 and the maximum value is 7, the higher the score the worse the outcome.
Time frame: The changes from baseline, week 12, week 24 and week 36.
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