We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tai Chi Training for Children With ADHD

This study is currently recruiting participants.
Verified August 2016 by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02234557
First Posted: September 9, 2014
Last Update Posted: August 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  Purpose

Attention Deficit Hyperactivity Disorder (ADHD) has tremendous individual and societal impact, and the effectiveness of current standard treatments is limited. We examine a novel treatment that could remediate the core features of ADHD and thereby contribute to sustained improvements in behavioral control. This approach is motivated by mounting evidence that children with ADHD show difficulties with motor control, and that these motor deficits are strongly associated with the core behavioral features of ADHD. We employ Tai Chi, targeting improvements in well-established behavioral and physiologic measures of motor control, and with this, improvements in ADHD symptoms. The proposed study offers immense potential for the development of novel therapeutic approaches for ADHD with little risk of adverse reaction.

The over-arching goal of this proposal is to examine a movement-based mindfulness training as a therapeutic intervention for children with ADHD. This approach is motivated by two complimentary lines of evidence: 1) Children with ADHD show impairments in motor control that parallel (and correlate with) core deficits in behavioral control that define the disorder. 2) Gains in cognitive and behavioral control have been observed in adults learning Tai Chi, dance, or meditation. These lines of evidence provide substantial motivation for our proposed investigation of movement-based mindfulness training in children with ADHD. Specifically, we propose to evaluate an established Tai Chi-based intervention. We chose this approach for a number of reasons: 1) Tai Chi is among the most well-established movement-based interventions with documented therapeutic effects, including cognitive effects. 2) While many movement-based approaches show evidence of yielding cognitive improvements Tai Chi provides excellent opportunities for engagement of 8-12 year old children in the form of the collaborative game "push hands." 3) Tai Chi instruction consists of gentle movements that can be practiced even by those with physical limitations, and is readily available in the United States so the protocols developed in this study will be straightforward to deploy at a national level.

Hypothesis: After participating in a Tai Chi program, children with ADHD will show improvements in behavioral and physiologic measures of motor control. We further expect movement-based training will result in decreases in ADHD symptom severity.


Condition Intervention Phase
ADHD Behavioral: Tai Chi Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Movement-Based Training for Children With ADHD: A Feasibility Study

Further study details as provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

Primary Outcome Measures:
  • Motor persistence score [ Time Frame: Change from baseline in total postintervention score, approx. 10 weeks ]

    A total score combining NEPSY ("A Developmental NEuroPSYchological Assessment") statue task and lateral gaze fixation.

    A halving of the distance from TD (Typically Developing) baseline for motor persistence measures (based on preexisting control data, and barring ceiling effects) will be regarded as a clinically meaningful change.



Secondary Outcome Measures:
  • TMS SICI (short-interval intracortical inhibition) [ Time Frame: Change from baseline in total postintervention score, approx. 10 weeks ]

    SICI is obtained in paired pulse TMS trials, in which the first conditioning subthreshold pulse causes the subsequent suprathreshold pulse, on average, to evoke a smaller response in muscle. We expect this SICI effect to be diminished in ADHD preintervention (i.e., less of a reduction). Postintervention, we expect more robust SICI reduction in muscle response (i.e., more like the typically developing baseline).

    This will be compared to results from stimulant medication, in which patients recovered approximately half-way towards typically developing baseline.


  • Cognitive motor control [ Time Frame: Change from baseline in total postintervention score, approx. 10 weeks ]
    RDoC (research domain criteria) battery for cognitive control targeting response inhibition delivered via laboratory computer (flanker task, Go / No-Go, and Stop Signal). We expect significant improvements across RDoC relevant scores.

  • Goniometer-based measures of sequential finger movements [ Time Frame: Change from baseline in total postintervention score, approx. 10 weeks ]
    Mirror overflow, speed, and rhythmicity will be assessed with goniometers during simple sequential finger movements. We expect reductions in overflow postintervention. We will report on changes in other measures, but these are not central to our hypothesis.

  • Evaluation of Tai Chi performance [ Time Frame: Change from baseline in total postintervention score, approx. 10 weeks ]
    Students will be asked to perform a subset of Tai Chi movements from the training, which will be scored on a 0-2 point scale for each movement. We expect performance to improve over the course of the intervention.


Other Outcome Measures:
  • Clinical measures of ADHD symptom severity and motor coordination [ Time Frame: Change from baseline in total postintervention score, approx. 10 weeks ]
    We will administer Connors and DuPaul surveys (parent versions), the BASC-2 (Behavior Assessment System for Children, Second Edition, parent and child versions), and DCDQ (Developmental Coordination Disorder Questionnaire). We expect improvements on these measures over the course of the intervention. In particular, based on Hernandez-Reif, et al. (2001), we expect marked improvements on Connors subscales for Anxiety, Conduct, Daydream, Emotion, and Hyperactive.

  • Behavioral assessments of basic motor control [ Time Frame: Change from baseline in total postintervention score, approx. 10 weeks ]
    We'll administer the PANESS (Physical and Neurologic Examination of Subtle Signs) and mABC-2 (Movement Assessment Battery for Children). We expect improvements over the course of the intervention.

  • Surveys of expectations [ Time Frame: preintervention ]
    Prospective survey to assess expectations at outset. Results will be reported as descriptive statistics and representative text samples.

  • Surveys of Satisfaction [ Time Frame: postintervention ]
    A retrospective survey to assess satisfaction and plans to continue with Tai Chi or other movement classes following the intervention. Results will be reported as descriptive statistics and representative text samples.


Estimated Enrollment: 40
Study Start Date: September 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tai Chi
Tai Chi instruction, 1 hour, twice per week Home Tai Chi practice with video, requesting 15-30 minutes, 3 times per week, monitored by practice log
Behavioral: Tai Chi

6-8 students will be enrolled in 8 weeks of Tai Chi instruction, with two 1-hour sessions per week. Students will be requested to practice from recorded materials at home three times a week for 15-30 minutes each session, and parents will be asked to keep a log of at-home practice.

Class sessions will consist of warm up (qi k'ong), postural and breathing exercises, Tai Chi form practice, and Tai Chi games (including push hands).

Practice will consist of warm up, followed by practice of selected pieces of the form.

Children on stimulant medications will remain on these medications during the training period (though they will be asked to stop medications one day prior to motor and cognitive testing pre-, mid- and postintervention).

Other Names:
  • taichi
  • tai ji
  • taiji
  • t'ai chi
  • t'ai ji

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children must meet diagnostic criteria for ADHD on the Kiddie Schedule for Affective Disorders and Schizophrenia
  • Comorbid oppositional defiant disorder (ODD) and simple phobias are permitted
  • right handed
  • Stimulant or no medication

Exclusion Criteria:

  • left handed
  • diagnosis of Intellectual Disability, Developmental Language Disorder, Reading Disability, or Autism (screened for using the Social Competence Questionnaire (SCQ)
  • neurologic disorder (e.g., epilepsy, cerebral palsy, traumatic brain injury, Tourette Syndrome)
  • documented hearing impairment ≥ 25 dB (decibel) loss in either ear.
  • history of speech/language disorder or a Reading Disability (RD)
  • a Full Scale IQ (Intelligence Quotient) score on the WISC-IV (Wechsler Intelligence Scale for Children) below 80
  • a standard score below 85 on the Word Reading Subtest, regardless of IQ score
  • foster care
  • previous participation in Tai Chi Training
  • parent and child report signs of puberty above Tanners-2
  • Female participants will be excluded if they are pregnant or may be pregnant
  • Non-stimulant psychoactive medications (e.g., atomoxetine, clonidine, tricyclic antidepressants, selective serotonin re-uptake inhibitors)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234557


Contacts
Contact: Stewart Mostofsky, MD 443-923-9266 mostofsky@kennedykrieger.org
Contact: Kristie Sweeney, MS 443-923-9254 sweeney@kennedykrieger.org

Locations
United States, Maryland
LEAP Facility at Kennedy Krieger Institute Recruiting
Baltimore, Maryland, United States, 21211
Principal Investigator: Stewart Mostofsky, MD         
Sponsors and Collaborators
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Investigators
Principal Investigator: Stewart Mostofsky, MD Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
  More Information

Responsible Party: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
ClinicalTrials.gov Identifier: NCT02234557     History of Changes
Other Study ID Numbers: 1R21MH104651-01 ( U.S. NIH Grant/Contract )
First Submitted: August 18, 2014
First Posted: September 9, 2014
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
Motor Control
Attention
Cognitive Control