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Breathing Meditation With Methylphenidate for the Treatment of Attention Deficit Hyperactivity Disorder

Primary Purpose

Attention Deficit Disorder With Hyperactivity

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Breathing Meditation
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring Attention Deficit Disorder with Hyperactivity, meditation, breathing meditation, Anapanasathi, randomized controlled trial, nonpharmacologic treatment, complementary and alternative medicine

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children diagnosed with ADHD by a child psychiatrist using DSM-IV-TR criteria Any religious background Age between 7-12 years. Voluntariness and can adhere to the program Exclusion Criteria: Autistic spectrum disorders Mental retardation

Sites / Locations

  • Department of Psychiatry, Faculty of Medicine, Khon Kaen UniversityRecruiting

Outcomes

Primary Outcome Measures

Conners' Abbreviated Parent Questionnaire (continuous outcome) assessed by the parents at baseline, end of 4-week , at 8 weeks, and at 12 weeks

Secondary Outcome Measures

Child Attention Problems (CAP) Rating Scale at the same time
Drugs used throughout 12 weeks program

Full Information

First Posted
April 4, 2006
Last Updated
May 27, 2010
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT00310986
Brief Title
Breathing Meditation With Methylphenidate for the Treatment of Attention Deficit Hyperactivity Disorder
Official Title
Breathing Meditation With Methylphenidate for the Treatment of Attention Deficit Hyperactivity Disorder Children: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
May 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Khon Kaen University

4. Oversight

5. Study Description

Brief Summary
In 2004, the Developmental Clinic of the Child Psychiatric Unit at Srinagarind Hospital, had 80 new pediatric cases of attention deficit hyperactivity disorder (ADHD) come for evaluation and intervention. The children were between 7-12 years of age. Most of them were treated with stimulant medication, (i.e. methylphenidate) to help reduce hyperactivity; however, both the parents and children needed special help to develop some techniques for behavioural management. Meditation has been used as an attention training method for many thousands of years, and was mostly involved with religious or spiritual practices in various parts of the world, especially in the eastern countries. Breathing meditation is a popular method which can be applied to all people without instructions that are too complicated. If meditation therapy, by breathing meditation which is specified to treat attention deficit hyperactivity disorders, benefits this group of patients, it would be very useful, culturally appropriate, cost-effective and would reduce the drugs used which will save the child from drug side effects.
Detailed Description
Attention Deficit Hyperactivity Disorder (ADHD) is the most common psychiatric disorder in children, with an estimated prevalence of 3-7% in school children (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision [DSM-IV-TR]). The major symptoms of this disorder are developmentally inconsistent and chronic levels of inattention, impulsiveness, and hyperactivity. The numbers of patients visiting physicians for ADHD are increasing from year to year. Boys are diagnosed with ADHD three times more often than girls. Although the studies on adolescents are few, the data suggest that about half of the children diagnosed with ADHD will have persistent symptoms into adolescence and some symptoms persist into adulthood. The symptoms of ADHD, if not adequately managed, will have many life long effects on the patients, families, friends, peers, teachers and colleagues. For the patients, the disorder will impact on patient's academic, social and emotional performance, and behavioural development, leading to poor academic achievement, low occupational status, increased risk of substance abuse and delinquency. More than 30% of children with ADHD repeat a year in school and up to 56% require remedial tutoring. Drug therapy began in the 1930s; since the 1970s, stimulants such as dexamphetamine, and methylphenidate have increasingly been used as the treatment of choice, but remain controversial. Currently available psychological treatments for ADHD include behavioural training for teachers and parents, and parenting skills classes, behavioural therapy for children with ADHD. Psychosocial treatments are generally combined with medication because each treatment alone has only a partial effect on the core symptoms of the disorder. Growing scientific evidence, clinical experience and community attitudes are encouraging a shift to more natural and holistic forms of therapy as alternatives or adjuncts to pharmacological approaches in a variety of conditions. Meditation has a wide range of applications, but it is especially useful in treating stress and related disorders to promote calmness and enhance the attentional ability. A psychological oriented definition stated that meditation is a set of attentional practices leading to an altered state or trait of consciousness characterized by expanded awareness, greater presence, and a more integrated sense of self. Breathing Meditation could be classified as both concentrative meditation and mindfulness meditation. The concentrative ability is first developed at the beginning state and followed by mindful ability. The studies which use meditation therapy for ADHD are still scarce. In Thailand, Hassasiri A, et al (1995) had developed meditation program for children with ADHD based on Neo-humanist concept which comprised of meditation and imagery . The program was tested in pre-post test design with purposive sampling and yielded the statistical significant different at p < 0.05 (unpublished data). There has never been research about the effectiveness of breathing meditation. We are interested in conducting a randomized controlled trial to study the effectiveness in patients with attention deficit hyperactivity disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
Attention Deficit Disorder with Hyperactivity, meditation, breathing meditation, Anapanasathi, randomized controlled trial, nonpharmacologic treatment, complementary and alternative medicine

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Breathing Meditation
Primary Outcome Measure Information:
Title
Conners' Abbreviated Parent Questionnaire (continuous outcome) assessed by the parents at baseline, end of 4-week , at 8 weeks, and at 12 weeks
Secondary Outcome Measure Information:
Title
Child Attention Problems (CAP) Rating Scale at the same time
Title
Drugs used throughout 12 weeks program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children diagnosed with ADHD by a child psychiatrist using DSM-IV-TR criteria Any religious background Age between 7-12 years. Voluntariness and can adhere to the program Exclusion Criteria: Autistic spectrum disorders Mental retardation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thawatchai Krisanaprakornkit, MD
Organizational Affiliation
Department of Psychiatry, Faculty of Medicine , Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, Faculty of Medicine, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suchat Paholpak, MD
Phone
66-43-348384
Email
suchat_p@kku.ac.th
First Name & Middle Initial & Last Name & Degree
Thawatchai Krisanaprakornkit, MD
First Name & Middle Initial & Last Name & Degree
Somjitr Rongbudsri, M.Ed.
First Name & Middle Initial & Last Name & Degree
Niramol Patjanasuntorn, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
15487477
Citation
Jensen PS, Kenny DT. The effects of yoga on the attention and behavior of boys with Attention-Deficit/ hyperactivity Disorder (ADHD). J Atten Disord. 2004 May;7(4):205-16. doi: 10.1177/108705470400700403.
Results Reference
result
PubMed Identifier
16437509
Citation
Krisanaprakornkit T, Krisanaprakornkit W, Piyavhatkul N, Laopaiboon M. Meditation therapy for anxiety disorders. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD004998. doi: 10.1002/14651858.CD004998.pub2.
Results Reference
result
PubMed Identifier
10944656
Citation
Scahill L, Schwab-Stone M. Epidemiology of ADHD in school-age children. Child Adolesc Psychiatr Clin N Am. 2000 Jul;9(3):541-55, vii.
Results Reference
result
PubMed Identifier
11795084
Citation
Barrows KA, Jacobs BP. Mind-body medicine. An introduction and review of the literature. Med Clin North Am. 2002 Jan;86(1):11-31. doi: 10.1016/s0025-7125(03)00069-5.
Results Reference
result
PubMed Identifier
9545994
Citation
Mannuzza S, Klein RG, Bessler A, Malloy P, LaPadula M. Adult psychiatric status of hyperactive boys grown up. Am J Psychiatry. 1998 Apr;155(4):493-8. doi: 10.1176/ajp.155.4.493.
Results Reference
result
Links:
URL
http://eckku.kku.ac.th/
Description
The Khon Kaen University Ethics Committee for Human research

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Breathing Meditation With Methylphenidate for the Treatment of Attention Deficit Hyperactivity Disorder

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