- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02482649
EAA/Therapy for Treating Children With ADHD
June 24, 2015 updated by: Samsung Medical Center
Equine-Assisted Activities and Therapy for Treating Children With Attention-Deficit/Hyperactivity Disorder
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yoo-Sook Joung, M.D.,Ph.D.
- Phone Number: 82-2-3410-0930
- Email: yschoung@skku.edu
Study Locations
-
-
-
Seoul, Korea, Republic of, 135-710
- Recruiting
- Yoo-Sook Joung
-
Contact:
- Yoo-Sook Joung, M.D., Ph.D.
- Phone Number: 82-2-3410-0930
- Email: yschoung@skku.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 13 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EAA/T
EAA/TEquine-Assisted Activities and Therapy) bi-weekly for 12eeks
|
bi-weekly for 12weeks
Other Names:
|
Active Comparator: Drugs
Methylphenidate or Atomoxetine
|
dosage adjustment according to clinical effectiveness, QD for 12weeks
Other Names:
dosage adjustment according to clinical effectiveness, QD or BID, for 12weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
chane of ARS-I score
Time Frame: change measures (baseline and 12 weeks)
|
change of Investigator-administered ADHD-Rating Scale (ARS-I) after Equine-Assisted Therapy
|
change measures (baseline and 12 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yoo-Sook Joung, M.D.,Ph.D., Department of Psychiatry, Samsung Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Anticipated)
August 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
June 24, 2015
First Submitted That Met QC Criteria
June 24, 2015
First Posted (Estimate)
June 26, 2015
Study Record Updates
Last Update Posted (Estimate)
June 26, 2015
Last Update Submitted That Met QC Criteria
June 24, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Adrenergic Uptake Inhibitors
- Methylphenidate
- Atomoxetine Hydrochloride
Other Study ID Numbers
- 2012-12-049
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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