TM Meditation in Children With ADD/ADHD

NCT03817593 | Withdrawn

• 1 other identifier: Sheba-18-5309-DG-CTIL
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Attention Deficit Disorder With Hyperactivity; Attention-Deficit Disorder in Adolescence

Keywords

meditation; heart rate variability; ADD; ADHD; children

Outcome Measures

Primary Outcomes (2)

• Achenbach Youth Self-Report (YSR) assesses overall behavioral and emotional functioning.

  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)

  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 Outcomes (2)

• Conners 3 questionnaire

  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)

  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

Study Arms (2)

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

Other: Transcendental Meditation (TM)

controls

Control group - Treatment as usual (TAU)

Interventions

Transcendental Meditation (TM) OTHER

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.

Transcendental Meditation (TM)

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

About 50 adolescents out of 60 adolescents, diagnosed with ADHD who study at at the Kadima Zoran School, Israel shall participate in this program.

You may qualify if:

• Children with a confirmed diagnosis of ADHD

You may not qualify if:

• Comorbidities of Conduct Disorder, ODD, OCD
• Children on psychiatric medications
• Other chronic diseases

Sponsors & Collaborators

• Sheba Medical Center: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Meditation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 25, 2019
• Study Start: November 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: May 24, 2022
• Last Updated: May 31, 2022

Record last verified: 2022-05