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临床试验/NCT02482649
NCT02482649Unknown不适用

Equine-Assisted Activities and Therapy for Treating Children With Attention-Deficit/Hyperactivity Disorder

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2013年1月最近更新:
适应症
干预措施

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

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

Experimental

EAA/TEquine-Assisted Activities and Therapy) bi-weekly for 12eeks

干预措施: EAA/T (Behavioral)

Drugs

Active Comparator

Methylphenidate or Atomoxetine

干预措施: Methylphenidate (Drug)

Drugs

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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