NCT02959528

Brief Summary

Previous studies indicated that children with attention-deficit/hyperactivity disorder (ADHD) often suffer from deficits in executive function, such as attentional control, inhibition, and working memory. One of these executive functions, working memory, plays a critical role in academic performance and classroom behavior. Working memory is essential for performing complex cognitive tasks such as comprehension, learning, and reasoning. Several studies have shown that training of working memory has positive effects for ADHD and other cognitive disorder in children. However, transfer effects across studies appear to be variable and inconsistent. Event-related potentials can be a useful tool to gain insights into such mechanism. Therefore, the aim of the present study is to investigate both near and far transfer effects of N-back training in children with ADHD. In addition, the recording and analysis of event-related potentials will be adopted while children with ADHD perform the complex visuo-spatial and phonological working memory tasks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

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

October 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

October 31, 2016

Last Update Submit

October 25, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Automated Working Memory Assessment

    Visuospatial working memory change after intervention measured by Automated Working Memory Assessment

    6 weeks

Secondary Outcomes (2)

  • Working memory index in Wechsler Intelligence Scale for Children-IV

    6 weeks

  • Event-related potentials

    6 weeks

Study Arms (2)

Control

ACTIVE COMPARATOR

ADHD group treated with visual-perceptual training

Other: perceptual training

Experiment

EXPERIMENTAL

ADHD group treated with working memory training

Other: Working memory training

Interventions

n-back training program

Experiment

visual-perceptual training program

Control

Eligibility Criteria

Age8 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ADHD diagnosed according to criteria specified in Diagnostic and statistical manual of mental disorders (DSM-5)
  • aged between 8 and 10 years
  • intelligence quotient \> 80 (based on Test of Nonverbal Intelligence-Third Edition)
  • had normal or corrected-to-normal vision
  • right-handed

You may not qualify if:

  • diagnosis of clinically significant oppositional defiant disorder, Autistic Spectrum Disorders, Asperger's syndrome or depression
  • history of seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taoyuan, Taiwan

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • I-Hsuan Shen, PhD

    Chang Gung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 9, 2016

Study Start

October 1, 2015

Primary Completion

November 25, 2016

Study Completion

January 19, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations