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

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

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:
  • Equine-Assisted Activities and Therapy
  • Hyppotherapy
Active Comparator: Drugs
Methylphenidate or Atomoxetine
dosage adjustment according to clinical effectiveness, QD for 12weeks
Other Names:
  • Metadate
  • Cencerta
dosage adjustment according to clinical effectiveness, QD or BID, for 12weeks
Other Names:
  • Strattera

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.

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

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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