Equine-Assisted Activities and Therapy for Treating Children With Attention-Deficit/Hyperactivity Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- chane of ARS-I score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 13 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a diagnosis of ADHD according to Diagnostic and Statistical Manual-IV-Text Version(DSM-IV-TR) and Korean Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Life¬time Version (K-SADS-PL)
排除标准
- •(1) a learning disorder or an intelligence quotient (IQ) measured by the Korean Wechsler Intelligence Scale for Children-IV (K-WISC-IV) < 70, (2) significant medical condition, schizophrenia or other psychotic disorder, bipolar disorder, a history of alcohol or drug dependence, neurologic disorders, epilepsy, and organic mental disorders; (3) a major depressive disorder that required pharmacotherapy; (4) significant suicidal ideation; (5) a Tourette's disorder or obsessive-compulsive disorder that required pharmacotherapy; (6) use of methylphenidate or atomoxetine within 90 days of baseline
研究组 & 干预措施
EAA/T
EAA/TEquine-Assisted Activities and Therapy) bi-weekly for 12eeks
干预措施: EAA/T (Behavioral)
Drugs
Methylphenidate or Atomoxetine
干预措施: Methylphenidate (Drug)
Drugs
Methylphenidate or Atomoxetine
干预措施: Atomoxetine (Drug)
结局指标
主要结局
chane of ARS-I score
时间窗: change measures (baseline and 12 weeks)
change of Investigator-administered ADHD-Rating Scale (ARS-I) after Equine-Assisted Therapy
次要结局
未报告次要终点
