NCT02234557

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 18, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

5.5 years

First QC Date

August 18, 2014

Last Update Submit

November 8, 2023

Conditions

Keywords

Motor ControlAttentionCognitive Control

Outcome Measures

Primary Outcomes (1)

  • Motor persistence score

    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.

    Change from baseline in total postintervention score, approx. 10 weeks

Secondary Outcomes (4)

  • TMS SICI (short-interval intracortical inhibition)

    Change from baseline in total postintervention score, approx. 10 weeks

  • Cognitive motor control

    Change from baseline in total postintervention score, approx. 10 weeks

  • Goniometer-based measures of sequential finger movements

    Change from baseline in total postintervention score, approx. 10 weeks

  • Evaluation of Tai Chi performance

    Change from baseline in total postintervention score, approx. 10 weeks

Other Outcomes (4)

  • Clinical measures of ADHD symptom severity and motor coordination

    Change from baseline in total postintervention score, approx. 10 weeks

  • Behavioral assessments of basic motor control

    Change from baseline in total postintervention score, approx. 10 weeks

  • Surveys of expectations

    preintervention

  • +1 more other outcomes

Study Arms (1)

Tai Chi

EXPERIMENTAL

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

Interventions

Tai ChiBEHAVIORAL

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).

Also known as: taichi, tai ji, taiji, t'ai chi, t'ai ji
Tai Chi

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LEAP Facility at Kennedy Krieger Institute

Baltimore, Maryland, 21211, United States

Location

Related Publications (1)

  • Clark D, Seymour KE, Findling RL, Mostofsky SH. Subtle Motor Signs as a Biomarker for Mindful Movement Intervention in Children with Attention-Deficit/Hyperactivity Disorder. J Dev Behav Pediatr. 2020 Jun/Jul;41(5):349-358. doi: 10.1097/DBP.0000000000000795.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Stewart Mostofsky, MD

    Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2014

First Posted

September 9, 2014

Study Start

July 17, 2014

Primary Completion

January 15, 2020

Study Completion

March 15, 2020

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

Locations