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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAU+EMT groups | Experimental | CAU+EMT group will continue their current interventions and medications as usual. The existing interventions and medications will be recorded and serve as covariates included in outcome analysis. Besides, CAU+EMT group will receive a total of 30 sessions of EMT within 12 weeks (2 - 3 sessions/week). |
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| CAU Group | No Intervention | CAU group will continue their current interventions and medications as usual. The existing interventions and medications will be recorded and serve as covariates included in outcome analysis.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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electromagnetic therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The changes from baseline to week 12, week 24 and week 36. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The changes from baseline, week 12, week 24 and week 36. |
| Children's Sleep Habits Questionnaire (CSHQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kwai Ching Lo, PHD | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Services Centres, The School of Chinese Medicine, The University of Hong Kong | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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The minimum vale of CSHQ is 0 and the maximum value is 66, the higher the score the worse the outcome. |
| 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. | 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. | The changes from baseline, week 12, week 24 and week 36. |