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| Name | Class |
|---|---|
| Samsung Electronics | INDUSTRY |
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The aim of this study is 1) to investigate clinical effects of equine-assisted activities and therapy (EAA/T) for treating attention-deficit/hyperactivity disorder (ADHD) and 2) to compare the clinical effect of EAA/T and drug therapy in children 6-13-years-of-age. This study is designed as a 12-week, prospective, open labeled trial, including 24 sessions of EAA/T. Forty six subjects will be enrolled and various clinical tests will be administered at baseline and after EAA/T or drug therapy.
This study is designed as a 12-week, prospective, open labeled trial, including 24 sessions of EAA/T. Forty six subjects will be aasigned 12 weeks of EAA/T or drug therapy, and various clinical tests will be administered at baseline and after EAA/T or drug therapy. Assessments included the investigator-administered ADHD-Rating Scale (ARS-I), Clinical Global Impressions - Severity scale (CGI-S), Clinical Global Impressions - Improvement scale (CGI-I), Gordon Diagnostic System (GDS), Korea-Child Behavior Checklist (K-CBCL), Self-Esteem Scale (SES), Bruininks-Oseretsky test of motor proficiency, second edition (BOT-2), and quantitative electroencephalography (QEEG) or functional magnetic resonance imaging(fMRI) study. This study has two objectives. The first objective is to investigate clinical effects of equine-assisted activities and therapy (EAA/T) for treating attention-deficit/hyperactivity disorder (ADHD). For this one, we determine the treatment response rate as the primary outcome measure. The treatment response is defined as ≥ 30% decline than baseline in the ARS-I score or in CGI-I scores of 1 or 2 to endpoint. The second objective is to compare the clinical effect of EAA/T and drug therapy in children with ADHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EAA/T | Experimental | EAA/TEquine-Assisted Activities and Therapy) bi-weekly for 12eeks |
|
| Drugs | Active Comparator | Methylphenidate or Atomoxetine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EAA/T | Behavioral | bi-weekly for 12weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| chane of ARS-I score | change of Investigator-administered ADHD-Rating Scale (ARS-I) after Equine-Assisted Therapy | change measures (baseline and 12 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoo-Sook Joung, M.D.,Ph.D. | Contact | 82-2-3410-0930 | yschoung@skku.edu |
| Name | Affiliation | Role |
|---|---|---|
| Yoo-Sook Joung, M.D.,Ph.D. | Department of Psychiatry, Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yoo-Sook Joung | Recruiting | Seoul | 135-710 | South Korea |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D008774 | Methylphenidate |
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Methylphenidate | Drug | dosage adjustment according to clinical effectiveness, QD for 12weeks |
|
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| Atomoxetine | Drug | dosage adjustment according to clinical effectiveness, QD or BID, for 12weeks |
|
|
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011437 | Propylamines |
| D000588 | Amines |