Clinical trial NCT02482649: EAA/Therapy for Treating Children With ADHD
Official title: Equine-Assisted Activities and Therapy for Treating Children With Attention-Deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Samsung Electronics
First posted: 2015-06-26
Enrollment: 46
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* (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

Primary outcomes:
measure: chane of ARS-I score
timeFrame: change measures (baseline and 12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yoo-Sook Joung
Study officials:
affiliation: Department of Psychiatry, Samsung Medical Center
name: Yoo-Sook Joung, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: