NCT06567444

Brief Summary

Prior research has found that children with attention-deficit hyperactivity disorder (ADHD) and reading difficulties (RD) are at an elevated risk of developing further cognitive deficits and developmental challenges. ADHD and RD are characterized by a deficit in working memory, which negatively affects learning and behavior. The main aims of this study were to design a working memory training app and examine its effectiveness through a 5-week training program in Chinese children with ADHD and/or RD. There were three experimental groups, with 26 participants in the ADHD group, 38 participants in the RD group, and 24 participants in the ADHD+RD group. The typically developing (TD) control group had 32 participants. All participants completed the pretest and posttest assessments on executive function and reading performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration 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

January 1, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

2.4 years

First QC Date

August 19, 2024

Last Update Submit

August 20, 2024

Conditions

Keywords

ADHDdyslexiaexecutive functioninterventiontraining appworking memory

Outcome Measures

Primary Outcomes (9)

  • Intellectual ability

    The Raven's Progressive Matrices comprises five sets (starting with set A and ending with set E) of 12 items each, totalling 60 items. Each presents a visual pattern with a missing piece. Participants were required to identify the missing piece that would complete the pattern.

    Two weeks before the pretest

  • Central executive function

    The central executive function subscale of BRIEF consists of 10 items. Teachers rated their student's behavior using a 3-point Likert scale (1 = never, 2 = sometimes; 3 = often). All 10 items were added together to form the central executive function subscale.

    One week before the intervention

  • Central executive function

    The central executive function subscale of BRIEF consists of 10 items. Teachers rated their student's behavior using a 3-point Likert scale (1 = never, 2 = sometimes; 3 = often). All 10 items were added together to form the central executive function subscale.

    One week after the intervention

  • Verbal working memory

    Verbal working memory capacity was measured using the third edition of the backward digit spans subtest from the Wechsler Intelligence Scale for Children (WISC-III). Participants were presented with two to nine orally delivered digits and asked to recall them in reverse order. They must retain auditory information while filtering out irrelevant details and focusing on relevant ones. The backward digit spans subtest consists of 18 trials, and participants who correctly repeated the backward digit sequence received one point.

    One week before the intervention

  • Verbal working memory

    Verbal working memory capacity was measured using the third edition of the backward digit spans subtest from the Wechsler Intelligence Scale for Children (WISC-III). Participants were presented with two to nine orally delivered digits and asked to recall them in reverse order. They must retain auditory information while filtering out irrelevant details and focusing on relevant ones. The backward digit spans subtest consists of 18 trials, and participants who correctly repeated the backward digit sequence received one point.

    One week after the intervention

  • Visual-spatial working memory

    Visual-spatial working memory was assessed using the Spatial Working Memory Test (SWM) from Cambridge Cognition. This computerized measure presents several boxes on the screen. Participants were asked to locate a hidden yellow token in each search. Once the token is collected, participants must continue searching for the remaining tokens until all of them have been found (the number of tokens equals the number of boxes). The token never appears in boxes where one has been found before. The number of boxes increases in difficulty from four to eight.

    One week before the intervention

  • Visual-spatial working memory

    Visual-spatial working memory was assessed using the Spatial Working Memory Test (SWM) from Cambridge Cognition. This computerized measure presents several boxes on the screen. Participants were asked to locate a hidden yellow token in each search. Once the token is collected, participants must continue searching for the remaining tokens until all of them have been found (the number of tokens equals the number of boxes). The token never appears in boxes where one has been found before. The number of boxes increases in difficulty from four to eight.

    One week after the intervention

  • Chinese word reading

    The 1-minute word reading test from HKT-P(III) was used to measure reading fluency. It consists of 120 simple Chinese two-character words. Participants were asked to read the words as quickly and accurately as possible within a minute. The total number of words read correctly was recorded, and the reading ability score can vary between 0 and 120.

    One week before the intervention

  • Chinese word reading

    The 1-minute word reading test from HKT-P(III) was used to measure reading fluency. It consists of 120 simple Chinese two-character words. Participants were asked to read the words as quickly and accurately as possible within a minute. The total number of words read correctly was recorded, and the reading ability score can vary between 0 and 120.

    One week after the intervention

Study Arms (4)

ADHD Group

EXPERIMENTAL

This experimental group received the working memory training conducted in primary schools in Hong Kong. This group was led by trained research assistants.

Other: Working memory intervention

RD Group

EXPERIMENTAL

This experimental group received the working memory training conducted in primary schools in Hong Kong. This group was led by trained research assistants.

Other: Working memory intervention

ADHD+RD Group

EXPERIMENTAL

This experimental group received the working memory training conducted in primary schools in Hong Kong. This group was led by trained research assistants.

Other: Working memory intervention

TD Group

NO INTERVENTION

The participants in the TD group did not receive any training.

Interventions

During the intervention, the participants in the ADHD group received five computerized working memory training sessions per week over five weeks, and each session lasted 20 minutes. This training paradigm is based on previous studies which show improvements in working memory capacities after a 5-week training period.

ADHD GroupADHD+RD GroupRD Group

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • being aged between 6 and 11
  • having an intelligence quotient (IQ) score above 80
  • having a clinical diagnosis of ADHD and/or RD from a clinical or educational psychologist or a psychiatrist
  • speaking native Cantonese

You may not qualify if:

  • brain damage, neurological issues, sensory problems, or psychiatric issues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Education University of Hong Kong

Tai Po, Hong Kong

Location

Related Publications (1)

  • Poon K, Ho MSH, Wang LC, Lee HM, Lau WKW, Chan WWL. Improving cognitive function in Chinese children with ADHD and/or RD through computerized working memory training. BMC Psychol. 2024 Oct 18;12(1):574. doi: 10.1186/s40359-024-02065-1.

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityDyslexia

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A single-blind study design was adopted in which all assessors were blinded to the treatment condition of the students. There were three experimental groups, with 26 participants in the ADHD group, 38 participants in the RD group, and 24 participants in the ADHD+RD group. The typically developing control group had 32 participants.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 22, 2024

Study Start

January 1, 2021

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

August 22, 2024

Record last verified: 2024-08

Locations