Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Khon Kaen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Khon Kaen University
ClinicalTrials.gov Identifier:
NCT00310986
First received: April 4, 2006
Last updated: May 27, 2010
Last verified: August 2009
  Purpose

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.


Condition Intervention
Attention Deficit Disorder With Hyperactivity
Behavioral: Breathing Meditation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Breathing Meditation With Methylphenidate for the Treatment of Attention Deficit Hyperactivity Disorder Children: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Khon Kaen University:

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

Estimated Enrollment: 22
Study Start Date: April 2006
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310986

Locations
Thailand
Department of Psychiatry, Faculty of Medicine, Khon Kaen University Recruiting
Khon Kaen, Thailand, 40002
Contact: Suchat Paholpak, MD    66-43-348384    suchat_p@kku.ac.th   
Principal Investigator: Thawatchai Krisanaprakornkit, MD         
Sub-Investigator: Somjitr Rongbudsri, M.Ed.         
Sub-Investigator: Niramol Patjanasuntorn, MD         
Sponsors and Collaborators
Khon Kaen University
Investigators
Principal Investigator: Thawatchai Krisanaprakornkit, MD Department of Psychiatry, Faculty of Medicine , Khon Kaen University
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00310986     History of Changes
Other Study ID Numbers: HE490230
Study First Received: April 4, 2006
Last Updated: May 27, 2010
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:
Attention Deficit Disorder with Hyperactivity
meditation
breathing meditation
Anapanasathi
randomized controlled trial
nonpharmacologic treatment
complementary and alternative medicine

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Methylphenidate
Central Nervous System Agents
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014