Effect and Safety of Integrative Treatment Program for Patients with Autism Spectrum Disorder: A Prospective Observational Study
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0008580
- Lead Sponsor
- Gachon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 50
1) Male and female children aged 12 to 30 months
2) Those who meet the criteria for autism spectrum disorder in the DSM-5
3) A child who has been diagnosed with autism spectrum disorder mild concern or higher on the toddler module, or autism spectrum disorder or autism on the module 2 by ADOS 2 test by a qualified clinical psychologist
4) A person whose legal representative voluntarily signed an IRB-approved research consent form
1) In case of accompanying neurological abnormalities (epilepsy, cerebral palsy, Down syndrome, etc.)
2) Those diagnosed with attention deficit hyperactivity disorder, schizophrenia, etc.
3) A person diagnosed with a serious chronic or terminal disease (malignant tumor, tuberculosis, etc.)
4) If you are taking risperidone or aripiprazole, it has been less than 3 months since you stopped taking it
5) If you are taking health functional food to improve autism spectrum disorder, a person who has been taking it for less than 2 weeks after stopping taking it
6) Those who are judged unsuitable for participation in research by investigators
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Childhood Autism Rating Scale, Second Edition
- Secondary Outcome Measures
Name Time Method Autism Diagnostic Observation Schedule™, Second Edition;Autism Behavior Checklist;Social Maturity Scale;Clinical Global Impression-Severity;Clinical Global Impression of Change;Patient Global Impression of Change;blood test;Adverse events investigation