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

May 27, 2010 updated by: Khon Kaen University

Breathing Meditation With Methylphenidate for the Treatment of Attention Deficit Hyperactivity Disorder Children: A Randomized Controlled Trial

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

22

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 Locations

      • Khon Kaen, Thailand, 40002
        • Recruiting
        • Department of Psychiatry, Faculty of Medicine, Khon Kaen University
        • Contact:
        • Principal Investigator:
          • Thawatchai Krisanaprakornkit, MD
        • Sub-Investigator:
          • Somjitr Rongbudsri, M.Ed.
        • Sub-Investigator:
          • Niramol Patjanasuntorn, MD

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

7 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Thawatchai Krisanaprakornkit, MD, Department of Psychiatry, Faculty of Medicine , Khon Kaen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

April 1, 2006

Primary Completion (ANTICIPATED)

December 1, 2009

Study Completion (ANTICIPATED)

May 1, 2011

Study Registration Dates

First Submitted

April 4, 2006

First Submitted That Met QC Criteria

April 4, 2006

First Posted (ESTIMATE)

April 5, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 28, 2010

Last Update Submitted That Met QC Criteria

May 27, 2010

Last Verified

August 1, 2009

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.

Clinical Trials on Attention Deficit Disorder With Hyperactivity

Clinical Trials on Breathing Meditation

Subscribe