Attention Deficit Disorder With HyperactivityNCT00310986
Breathing Meditation With Methylphenidate for the Treatment of Attention Deficit Hyperactivity Disorder
A study testing Breathing Meditation in people with Attention Deficit Disorder With Hyperactivity, run by Khon Kaen University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Breathing Meditation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 22 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2006to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Autistic spectrum disorders
- Mental retardation
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of Psychiatry, Faculty of Medicine, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, 40002
Suchat Paholpak, MD, 66-43-348384, suchat_p@kku.ac.th
Thawatchai Krisanaprakornkit, MD
About this study
Official title: 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.
Read the 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.
- Being tested
- Breathing Meditation
- Keywords
- Attention Deficit Disorder with Hyperactivity, meditation, breathing meditation, Anapanasathi, randomized controlled trial, nonpharmacologic treatment, complementary and alternative medicine
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing MeditationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Conners' Abbreviated Parent Questionnaire (continuous outcome) assessed by the parents at baseline, end of 4-week , at 8 weeks, and at 12 weeks
Secondary outcomes (2)
Child Attention Problems (CAP) Rating Scale at the same time
Drugs used throughout 12 weeks program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2009 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Investigators
- Thawatchai Krisanaprakornkit, MD, Principal investigator, Department of Psychiatry, Faculty of Medicine , Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310986
- Sponsor's protocol ID
- HE490230
- Status last verified
- Aug 2009
- First submitted
- 4 Apr 2006
- Last updated
- 28 May 2010
- Results posted
- No
Publications
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.
PubMed 15487477Krisanaprakornkit T, Krisanaprakornkit W, Piyavhatkul N, Laopaiboon M. Meditation therapy for anxiety disorders. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD004998. doi: 10.1002/14651858.CD004998.pub2.
PubMed 16437509Scahill L, Schwab-Stone M. Epidemiology of ADHD in school-age children. Child Adolesc Psychiatr Clin N Am. 2000 Jul;9(3):541-55, vii.
PubMed 10944656Barrows 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.
PubMed 11795084Mannuzza 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.
PubMed 9545994
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathing Meditation With Methylphenidate for the Treatment of Attention Deficit Hyperactivity Disorder Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00310986
- Acronym / sponsor ID
- HE490230
- Keywords
- Attention Deficit Disorder with Hyperactivity, meditation, breathing meditation, Anapanasathi, randomized controlled trial, nonpharmacologic treatment, complementary and alternative medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Dec 2009 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 5 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Autistic spectrum disorders
- Mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing Meditation | Behavioural | – |
Primary outcome
Conners' Abbreviated Parent Questionnaire (continuous outcome) assessed by the parents at baseline, end of 4-week , at 8 weeks, and at 12 weeks
2 secondary outcomes
Child Attention Problems (CAP) Rating Scale at the same time
Drugs used throughout 12 weeks program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2010.
- Results publication: PubMed 15487477Jensen 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 publication: PubMed 16437509Krisanaprakornkit T, Krisanaprakornkit W, Piyavhatkul N, Laopaiboon M. Meditation therapy for anxiety disorders. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD004998. doi: 10.1002/14651858.CD004998.pub2.
- Results publication: PubMed 10944656Scahill 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 publication: PubMed 11795084Barrows 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 publication: PubMed 9545994Mannuzza 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.
- The Khon Kaen University Ethics Committee for Human researchLink provided by the sponsor.
- Faculty of Medicine , KhonKaen University , ThailandLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Department of Psychiatry, Faculty of Medicine, Khon Kaen University
Khon Kaen, Thailand
Thawatchai Krisanaprakornkit, MD principal investigator
Department of Psychiatry, Faculty of Medicine , Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing Meditation in people with Attention Deficit Disorder With Hyperactivity, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00310986, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2010.