Neuroplasticity Technology for Attention-deficit/Hyperactivity Disorder (ADHD)

NCT03363568 | Completed

• 1 other identifier: IRB-P00005840
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the impact of computerized inhibitory control training on attention-deficit hyperactivity disorder (ADHD) symptoms and ADHD-linked neural signatures in children with ADHD. Children were randomly assigned to adaptive computerized training (n=20) or non-adaptive computerized training control (n=20) with identical stimuli and goals.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

• Change in Average Parent-Reported Inattention Symptoms

  Parent-report of inattention symptoms using the Swanson, Nolan, and Pelham Questionnaire (SNAP-IV). The SNAP-IV is based on a 0 to 3 rating scale (Not at All = 0, Just A Little = 1, Quite a Bit = 2, and Very Much = 3). Subscale inattention items are calculated by summing the score for the 9 inattention items and dividing by 9.

  Baseline and 4-weeks

• Change in Average Parent-Reported Hyperactivity Symptoms

  Parent-report of hyperactivity symptoms used the Swanson, Nolan, and Pelham Questionnaire (SNAP-IV). The SNAP-IV is based on a 0 to 3 rating scale (Not at All = 0, Just A Little = 1, Quite a Bit = 2, and Very Much = 3). Subscale hyperactivity items are calculated by summing the score for the 9 hyperactivity items and dividing by 9.

  Baseline and 4-weeks

Secondary Outcomes (4)

• Change in Relative Theta Power During Resting-State Electroencephalogram(EEG) Recording

  Baseline and 4-weeks

• Change in Teacher Reported Inattention

  Baseline and 4-weeks

• Change in Teacher Reported Hyperactivity

  Baseline and 4-weeks

• Change in N200 Event-Related Potential (ERP) Component During Inhibition

  Baseline and 4-weeks

Other Outcomes (5)

• Change in NEPSY-II Inhibition Scale Score

  Baseline and 4-weeks

• Change in Math Ability on the Woodcock Johnson III

  Baseline and-4 weeks

• Change in Working Memory Capacity

  Baseline and 4 weeks

Study Arms (2)

Adaptive Inhibitory Control Training

EXPERIMENTAL

Participants played a set of three modified stop-signal reaction time tasks designed by NeuroScouting, LLC at home for approximately 5 days a week (25 min/day) for 4-weeks. This condition involved real-time adaptive gameplay that increased in difficulty as performance increased.

Behavioral: Adaptive Inhibitory Control Training

Non-Adaptive Inhibitory Control Training

ACTIVE COMPARATOR

Participants played a set of three modified stop-signal reaction time tasks designed by NeuroScouting, LLC at home for approximately 5 days a week (25 min/day) for 4-weeks. This condition had no change in difficulty (non-adaptive gameplay).

Behavioral: Non-adaptive Inhibitory Control Training

Interventions

Adaptive Inhibitory Control Training BEHAVIORAL

Playing computerized stop-signal reaction time tasks that had been modified to increase in difficulty as performance increased.

Adaptive Inhibitory Control Training

Non-adaptive Inhibitory Control Training BEHAVIORAL

Playing computerized stop-signal reactions time tasks that do not change in difficulty level (non-adaptive).

Non-Adaptive Inhibitory Control Training

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of inattentive or combined subtype ADHD by a licensed clinician and consistent acess to Wi-Fi at home.

You may not qualify if:

• Any known genetic abnormalities, a diagnosis of autism spectrum disorder, or current use of medication for psychiatric disorders other than ADHD (e.g. depression, anxiety).

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Neuroscouting, L.L.C.: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (7)

• Barkley RA. Behavioral inhibition, sustained attention, and executive functions: constructing a unifying theory of ADHD. Psychol Bull. 1997 Jan;121(1):65-94. doi: 10.1037/0033-2909.121.1.65.

  PMID: 9000892 BACKGROUND

• Nigg JT. Is ADHD a disinhibitory disorder? Psychol Bull. 2001 Sep;127(5):571-98. doi: 10.1037/0033-2909.127.5.571.

  PMID: 11548968 BACKGROUND

• Vaidya CJ, Bunge SA, Dudukovic NM, Zalecki CA, Elliott GR, Gabrieli JD. Altered neural substrates of cognitive control in childhood ADHD: evidence from functional magnetic resonance imaging. Am J Psychiatry. 2005 Sep;162(9):1605-13. doi: 10.1176/appi.ajp.162.9.1605.

  PMID: 16135618 BACKGROUND

• Barry, R. J., and Clarke, A. R. (2012) Resting state EEG and symptoms of ADHD. Int. J. Psychophysiol. 85, 294.

  BACKGROUND

• Rapport MD, Orban SA, Kofler MJ, Friedman LM. Do programs designed to train working memory, other executive functions, and attention benefit children with ADHD? A meta-analytic review of cognitive, academic, and behavioral outcomes. Clin Psychol Rev. 2013 Dec;33(8):1237-52. doi: 10.1016/j.cpr.2013.08.005. Epub 2013 Aug 24.

  PMID: 24120258 BACKGROUND

• Johnstone SJ, Roodenrys S, Phillips E, Watt AJ, Mantz S. A pilot study of combined working memory and inhibition training for children with AD/HD. Atten Defic Hyperact Disord. 2010 Mar;2(1):31-42. doi: 10.1007/s12402-009-0017-z. Epub 2010 Jan 28.

  PMID: 21432588 BACKGROUND

• Meyer KN, Santillana R, Miller B, Clapp W, Way M, Bridgman-Goines K, Sheridan MA. Computer-based inhibitory control training in children with Attention-Deficit/Hyperactivity Disorder (ADHD): Evidence for behavioral and neural impact. PLoS One. 2020 Nov 30;15(11):e0241352. doi: 10.1371/journal.pone.0241352. eCollection 2020.

  PMID: 33253237 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Margaret Sheridan, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Children were randomly assigned to adaptive treatment (n=20) or non-adaptive control (n=20) with identical tasks, stimuli, and goals. Children were instructed to train for 5 days a week (25m/day) for 4-weeks. All participants had between 10-20 training sessions at study completion.

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: December 6, 2017
• Study Start: July 18, 2013
• Primary Completion: March 3, 2014
• Study Completion: March 3, 2014
• Last Updated: December 12, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)