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EAA/Therapy for Treating Children With ADHD

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EAA/T
Methylphenidate
Atomoxetine
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

6 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yoo-Sook JoungRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EAA/T

Drugs

Arm Description

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

Methylphenidate or Atomoxetine

Outcomes

Primary Outcome Measures

chane of ARS-I score
change of Investigator-administered ADHD-Rating Scale (ARS-I) after Equine-Assisted Therapy

Secondary Outcome Measures

Full Information

First Posted
June 24, 2015
Last Updated
June 24, 2015
Sponsor
Samsung Medical Center
Collaborators
Samsung Electronics
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1. Study Identification

Unique Protocol Identification Number
NCT02482649
Brief Title
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

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
Collaborators
Samsung Electronics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EAA/T
Arm Type
Experimental
Arm Description
EAA/TEquine-Assisted Activities and Therapy) bi-weekly for 12eeks
Arm Title
Drugs
Arm Type
Active Comparator
Arm Description
Methylphenidate or Atomoxetine
Intervention Type
Behavioral
Intervention Name(s)
EAA/T
Other Intervention Name(s)
Equine-Assisted Activities and Therapy, Hyppotherapy
Intervention Description
bi-weekly for 12weeks
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Other Intervention Name(s)
Cencerta, Metadate
Intervention Description
dosage adjustment according to clinical effectiveness, QD for 12weeks
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Other Intervention Name(s)
Strattera
Intervention Description
dosage adjustment according to clinical effectiveness, QD or BID, for 12weeks
Primary Outcome Measure Information:
Title
chane of ARS-I score
Description
change of Investigator-administered ADHD-Rating Scale (ARS-I) after Equine-Assisted Therapy
Time Frame
change measures (baseline and 12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yoo-Sook Joung, M.D.,Ph.D.
Phone
82-2-3410-0930
Email
yschoung@skku.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoo-Sook Joung, M.D.,Ph.D.
Organizational Affiliation
Department of Psychiatry, Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yoo-Sook Joung
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoo-Sook Joung, M.D., Ph.D.
Phone
82-2-3410-0930
Email
yschoung@skku.edu

12. IPD Sharing Statement

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EAA/Therapy for Treating Children With ADHD

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