- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02688959
Motor Attention Training for Attention Deficit Hyperactivity Disorder (ADHD)
May 29, 2025 updated by: University of Wisconsin, Madison
A Feasibility/Pilot Trial of a Motor Attention Training Intervention for College Students With ADHD
The investigators will perform a feasibility/pilot trial of two non-pharmacological interventions for ADHD in college students.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
College students diagnosed with ADHD will be randomized to three arms of approximately 8 weeks duration: (1) standard care plus a tai chi class, (2) standard care plus an exercise class, and (3) standard care alone.
The exercise class will control for the social and motor components of tai chi training.
The investigators will determine methodological parameters relevant to a subsequent full scale trial including recruitment and retention rates, acceptance of randomization, adherence to the interventions, and variance in outcome measures.
The primary clinical outcome measure of this pilot randomized controlled trial (RCT) will be pre- to post-intervention change in inattention, i.e. the Inattentive Symptoms subscale of the Conners Adult ADHD Rating Scale self-report long form (CAARS-S:L, see Interviews etc. "Converse_S_L").
Secondary measures to be explored will include self- and informant-report, neurocognitive measures, psychophysiological measures, and academic performance.
Practice time will be assessed daily and follow-up self-report of ADHD symptoms will be gathered monthly for 3 months beyond the end of the intervention.
Study Type
Interventional
Enrollment (Estimated)
145
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alexander K Converse, PhD
- Phone Number: 608 265 6604
- Email: adhd@bi.wisc.edu
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- Recruiting
- University of Wisconsin-Madison, Waisman Center
-
Contact:
- Alexander K Converse, PhD
- Phone Number: 608-265-6604
- Email: adhd@bi.wisc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 23 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- University of Wisconsin-Madison enrolled undergraduate
- Documented ADHD diagnosis
Exclusion Criteria:
- Unable or unwilling to participate in the interventions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tai Chi
Participants in this arm will attend 50-minute classes 2 times per week for 8 weeks.
The course will emphasize experiential learning with 2 weeks of introductory sessions on gait, posture, and tai chi principles followed by instruction in the 24-form Yang style sequence.
Students will be given a video to aid learning outside of class, and maintenance of practice post-intervention.
|
|
|
Active Comparator: Exercise
Participants in the exercise arm will attend 50-minute classes 2 times per week for 8 weeks.
The course will emphasize cardio-aerobic fitness training.
Students will be given a video to aid practice outside of class, and maintenance of practice post-intervention.
|
|
|
No Intervention: Control
Participants in the control arm will not attend a class and not be given a video.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in symptoms of inattention
Time Frame: 8 weeks
|
Inattentive Symptoms subscale of the Conners Adult ADHD Rating Scale self-report long form (CAARS-S:L).
The total range of scores is 0-27 with higher scores indicating more severe symptom levels.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of implementing wireless Electroencephalogram(EEG) to measure the theta beta ratio during performance of tai chi.
Time Frame: up to 90 minute
|
Feasibility of implementing wireless EEG will be assessed by the quality of EEG data.
Acceptable data should have satisfactory signal to noise characteristics.
Satisfactory signal to noise ratio will be evaluated by the variance within individual across trials of the ratio of occipital alpha power between the eyes closed and eyes open conditions.
Feasibility will be judged by the criterion that the coefficient of variance (CV = s.d./mean) be less than 1/3.
|
up to 90 minute
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alexander K Converse, PhD, University of Wisconsin, Madison
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Converse AK, Ahlers EO, Travers BG, Davidson RJ. Tai chi training reduces self-report of inattention in healthy young adults. Front Hum Neurosci. 2014 Jan 27;8:13. doi: 10.3389/fnhum.2014.00013. eCollection 2014.
- Converse AK, Barrett BP, Chewning BA, Wayne PM. Tai Chi training for attention deficit hyperactivity disorder: A feasibility trial in college students. Complement Ther Med. 2020 Sep;53:102538. doi: 10.1016/j.ctim.2020.102538. Epub 2020 Aug 14.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Study Registration Dates
First Submitted
February 18, 2016
First Submitted That Met QC Criteria
February 22, 2016
First Posted (Estimated)
February 23, 2016
Study Record Updates
Last Update Posted (Actual)
June 4, 2025
Last Update Submitted That Met QC Criteria
May 29, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-0807
- A348700 (Other Identifier: UW Madison)
- VCRGE\WAISMAN CENTER\WAISMAN (Other Identifier: UW Madison)
- Protocol version 15 July 2024 (Other Identifier: IRB UW, Madison)
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.
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