- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03817593
TM Meditation in Children With ADD/ADHD
The Assessment of Transcendental Meditation Training on ADD/ADHD Symptoms of Adolescents.
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common developmental disorders experienced in childhood, with limited options for effective pharmacological treatment. Transcendental Meditation (TM) has been proposed to be used as a tool for attentional training and modulating autonomic nervous system activity in the ADHD population. However, the empirical support in favor of meditation for ADHD is limited, and the mechanism by which TM may have an effect on ADD/ADHD is not understood. There is also a conflicted data as to the nature of autonomic dysregulation of ADHD.
Heart Rate Variability (HRV) represents the beat to beat changes of heart rate in the interbeat interval, and considered to be a non-invasive tool to study autonomic nervous system. There is evidence that a non-directive meditation may increase parasympathetic activity and overall HRV. To the best of our knowledge, the differential effect of meditation on ADHD symptoms: according to the baseline HRV of the participants, or ADHD subtypes has not been assessed.
The aim of this study is to collect the data on ADHD adolescents who will get TM training as a part of out-of-school program, which is offered all children diagnosed with ADD/ADHD, aged 11.5 y-16y, in the community center of Kadima-Zoran, Israel.
The assessment of all of the children participating in this program will be performed with the help of validated questionnaires for diagnosis and follow-up of ADD/ADHD, and HRV monitoring.
In order to perform an assessment in a controlled way, the instruction of TM shall take place in two cycles of 3 months each.
Study Overview
Status
Intervention / Treatment
Detailed Description
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common developmental disorders experienced in childhood, with a prevalence of 5 -10%, and can persist into adulthood (1) It is characterized by a combination of overactive, poorly modulated behavior with marked inattention and may involve physical aggression, which may be associated with a number of structural and functional abnormalities in the central nervous system (2).
Pharmacological treatment is often the treatment of choice; however its effectiveness is limited and often involves considerable side effects (3).
Meditation has been proposed to be used as a tool for attentional training and modulating autonomic nervous system activity in the ADHD population. A systematic review of meditation- based interventions for children with ADHD could not reach definite conclusions regarding their efficacy due to poor methodological quality of the studies (4).
A pilot randomized controlled study published few years ago demonstrated that three months of TM practice resulted in significant improvement of ADHD symptoms (5).
The mechanism by which TM may have an effect on ADD/ADHD is not understood. Furthermore, it is not clear whether TM may have a differential effect on the two subclasses of this condition: inattentive- and hyperactive- type
Individuals with ADHD probably have imbalances in autonomic nervous system activity, which may be associated with impairment of sustained attention (6) and emotional regulation (7,8,9).
Heart Rate Variability (HRV) represents the beat to beat changes of heart rate in the interbeat interval, resulting from dynamic balance of sympathetic and parasympathetic inputs to the heart being a non-invasive tool to study autonomic nervous system, has been proposed to be related to cognitive performance (10) and be a potential marker of stress (11). A lower resting HRV has been associated with greater difficulties in emotional regulation, especially a lack of emotional clarity and impulse control (12), depression and anxiety states (15), while higher levels - with higher cognitive performance, increased emotional regulation and perception of well-being (13, 14).
There is however no agreement as to the nature of autonomic dysregulation of ADHD (9,16,17).
The effect of meditation on autonomic nervous system via changes in heart rate variability has been studied recently. Interestingly, some of the techniques were associated with lower HRV (18), while others - with increased parasympathetic activity and HRV (19). To the best of our knowledge, the differential effect of meditation on ADHD symptoms: according to the baseline HRV of the participants, or ADHD subtypes has not been assessed.
Aims
Primary objective:
To collect the data on ADHD adolescents who will get TM training
Secondary objectives:
- To assess whether improvement of symptoms may be sustained for 3 months after the intervention.
- To assess whether the effect of TM on ADHD symptoms may be correlated with the baseline HRV or ADHD subtypes of the participants.
Participants and Methods
Study design TM classes are going to take place in the facility of Community Center at the Kadima Zoran Community Center for Culture and Sport (as an out-of-school program): a group of TM instructors will provide TM teaching to the adolescents with ADD/ADHD of the Zoran school, with the consent of the teachers and the parents of the children.
Since March 2019, the TM classes will be offered to all children aged 11.5 y-16y, with a confirmed diagnosis of ADD/ADHD, under supervision of the school teachers.
About 50 adolescents out of 60 adolescents, diagnosed with ADHD shall participate in this program.
The assessment and follow-up on these children will be performed by pediatric neurologist and HRV monitoring.
The instruction of TM shall be in two groups (of 20-30 children each). TM training for each group shall be 3 months. The children in both groups shall be followed up for 6 months, and assessed by the same parameters.
Participants:
About 50 adolescents out of 60 adolescents, diagnosed with ADHD who study at this school, are expected to participate in this program.
A senior pediatric neurologist will examine the children, confirm the diagnosis, according to the DSM 5 criteria, and shall obtain a written informed consent for the evaluation of the children during this program.
Current pharmacological treatment, ADHD subtype (e.g. inattentive type, combined type or mixed type) and the comorbidities will be documented.
Group 1
Two certified teachers of TM will teach these children according to the following protocol, as previously described by Grosswald et al(20):
Each participant will have an individual instruction for 1 hour, followed by a course of 3 weekly group meetings (1-1.5 hours) The students shall meditate in a group for 10 minutes, twice a day, during 3 months, under the supervision of school teachers who will be instructed in TM technique.
A group follow-up will be performed 10 days after a completion of the course, and then each participant will receive personal meetings with TM instructor on a weekly basis during the first month, and then twice a month.
After additional 3 months participants in this group will be examined again, to assess sustainability of the effect.
Group 2 Following the completion of the first 3 months period, the second group will receive TM training as above, and during the first 3 months this will be a reference (control) group.
Data analysis
The data will be analyzed according to the treatment groups. Similarly to the previous study (20) the expected statistical power of 93%will be calculated for comparison of means (Student T-test) .The assumed difference between groups is 0.1 and adopted Standard Deviation within the groups is ±0.1 (20).
Additional observations will be assessed according to the baseline HRV (sympathetic or parasympathetic predominance) and the ADHD subgroups (inattentive or hyperactive predominance), while the two ADHD subgroups and two HRV subgroups will be assessed independently with dichotomous outcomes. In the probable case that the two TM groups (A&B) shall not be significantly different, both groups may br assessed as one cohort with n=50, assuming dichotomous outcomes. This project may provide a preliminary assessment of the impact of ADHD subtype and of baseline HRV on the differential effect of TM on ADHD symptoms.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Children with a confirmed diagnosis of ADHD
Exclusion Criteria:
- Comorbidities of Conduct Disorder, ODD, OCD
- Children on psychiatric medications
- Other chronic diseases
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Transcendental Meditation (TM)
Each participant will have an individual instruction for 1 hour, followed by a course of 3 weekly group meetings (1-1.5 hours) The students shall meditate in a group for 10 minutes, twice a day, during 3 months, under the supervision of school teachers who will be instructed in TM technique. To ensure the quality of practice, a group follow-up will be performed 10 days after a completion of the course, and then each participant will receive personal meetings with TM instructor on a weekly basis during the first month, and twice a month for the second and third months. After additional 3 months participants in this group will be examined again, to assess sustainability of the effect |
Each participant will have an individual instruction for 1 hour, followed by a course of 3 weekly group meetings (1-1.5 hours) The students shall meditate in a group for 10 minutes, twice a day, during 3 months, under the supervision of school teachers who will be instructed in TM technique.
|
controls
Control group - Treatment as usual (TAU)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Achenbach Youth Self-Report (YSR) assesses overall behavioral and emotional functioning.
Time Frame: The changes in scoring of this questionnaire from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months
|
A self-reported scale that assesses overall behavioral and emotional functioning.
appropriate behaviors, as well as inappropriate ones.
The scale is designed for both parents and teachers, contains both social competency and behavior problem items.
|
The changes in scoring of this questionnaire from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months
|
Cardiac vagal tone - indexed by heart rate variability (HRV)
Time Frame: The changes in HRV from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months
|
HRV refers to changes in normal cardiac interbeat intervals, are under control of the vagus nerve (21), may be a biomarker of psychopathology (22) and of faster recovery from stress (23).
HRV is also linked to social and emotional function and can be seen as an objective measure of emotional and social functioning both in healthy and ill population (24).
|
The changes in HRV from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Conners 3 questionnaire
Time Frame: The changes in scoring of this questionnaire from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months
|
Assesses cognitive, behavioral, and emotional problems, with a focus on ADHD and comordbid disorders-providing teacher, parent, and student perspectives
|
The changes in scoring of this questionnaire from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months
|
Behavior Rating Inventory of Executive Function (BRIEF)
Time Frame: The changes in scoring of this questionnaire from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months
|
Assesses executive function behaviors in the school and home environments.
The questionnaire was developed for parents and teachers of school-age children and is designed to assess the abilities of a broad range of children and adolescents.
Tthe BRIEF is useful when working with children who have learning disabilities and attention disorders, traumatic brain injuries, lead exposure, pervasive developmental disorders, depression, and other developmental, neurological, psychiatric, and medical conditions.
|
The changes in scoring of this questionnaire from the baseline will be evaluated at the beginning of the study (time 0), after 3 months of TM instruction and after additional 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sheba-18-5309-DG-CTIL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
Ornit CohenUnknownAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | Attention Deficit Disorder | Attention Deficit Disorders With Hyperactivity | Attention Deficit Hyperactivity DisordersIsrael
-
Cingulate TherapeuticsRecruitingPhase 3 Efficacy and Safety Laboratory Classroom Study in Pediatrics (6-12) With ADHD Using CTx-1301ADHD | Attention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | ADHD - Combined Type | Attention Deficit Hyperactivity Disorder Combined | Attention Deficit Hyper Activity | Attention-deficit HyperactivityUnited States
-
Karolinska InstitutetCompletedAttention Deficit Disorder With Hyperactivity (ADHD)Sweden
-
Fondation LenvalCompletedAttention Deficit Disorder With Hyperactivity | Attention Deficit Disorder Without HyperactivityFrance
-
Rabin Medical CenterNG Solutions LtdRecruitingADHD - Attention Deficit Disorder With HyperactivityIsrael
-
Clinical and Translational Genome Research Institute...Children's Specialized HospitalTerminatedAttention Deficit Disorders With HyperactivityUnited States
-
University of PennsylvaniaCompletedAttention Deficit Disorder With Hyperactivity (ADHD)United States
-
Nemours Children's ClinicCompletedAttention Deficit Hyperactivity Disorder | Attention Deficit Disorder With Hyperactivity | Attention Deficit DisorderUnited States
-
Massachusetts General HospitalRecruitingAttention Deficit Disorder With Hyperactivity | Attention Deficit DisorderUnited States
-
New River PharmaceuticalsShireCompletedAttention Deficit Hyperactivity Disorder | Attention Deficit Disorders With Hyperactivity | Attention Deficit Hyperactivity DisordersUnited States
Clinical Trials on Transcendental Meditation (TM)
-
Maharishi International UniversityColumbia UniversityUnknownCoronary Artery DiseaseUnited States
-
Maharishi International UniversityAmerican University; Abramson Family FoundationCompletedPsychological Stress | High-normal Blood PressureUnited States
-
Maharishi International UniversityCenter for Wellness and Achievement in EducationCompletedJob Stress | Perceived Stress
-
Maharishi International UniversityMedical College of WisconsinCompletedCardiovascular Disease | Coronary Heart DiseaseUnited States
-
Maharishi International UniversityWestern Oregon University; Maharishi University of Management Research InstituteCompletedStress Disorders, Post-Traumatic
-
Duke UniversityTerminatedCovid19 | Burnout, Professional | Exhaustion, CaregiverUnited States
-
Research Foundation for Mental Hygiene, Inc.University of California, San Diego; Northwell Health; Columbia University; Icahn... and other collaboratorsRecruiting
-
Maharishi International UniversityCompletedStress | Happiness | Self Efficacy | ResilienceLebanon
-
Maharishi International UniversityMedical College of WisconsinCompletedHigh Blood Pressure
-
Duke UniversityCompletedBurnout, Professional | Stress, PsychologicalUnited States