- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06766149
CogniFit Computerized Cognitive Training in Primary School Students in Hong Kong
The Effects of Computerized Cognitive Training on Executive Function in Children in Hong Kong
This study aims to address these gaps by conducting a comprehensive evaluation of the effects of CogniFit training in children. The primary objective of this study is to evaluate the effectiveness of CogniFit training on executive functions among primary school students in Hong Kong.
Specific objectives include:
- To assess the effectiveness of CogniFit training on improving executive functions, such as working memory, attention, and inhibitory control in children compared to a waitlist control group.
- To assess the effectiveness of CogniFit training on improving executive functions, such as working memory, attention, and inhibitory control in children compared to an active control group that will receive Cogmed training.
Participants will be randomly assigned to one of three groups: 1) the CogniFit training group; 2) the Cogmed Group, and 3) the wailist controlled group.
Participants in the two computerized cognitive training groups (CogniFit/Cogmed Group) will receive training in the first phase of intervention, while the waitlist control group will CogniFit trainings in the second phase of intervention.
Participants who receive the computerized cognitive training will complete 24 sessions of training, 15-20 minutes each, conducted three times per week spanning 8 weeks. These programs comprise a range of game-like exercises targeting various cognitive skills, including working memory, attention, and inhibitory control, with automatic level advancement after each exercise.
To investigate the intervention effectiveness, children will be asked to complete a set of cognitive tests covering inhibitory control, attention, and working memory prior to the intervention (i.e., Time 1), immediately after the 8-week training (i.e., Time 2), and 2 months after the training (i.e., Time 3, a 2-month follow up). The assessment will take around 1 hour and it will be conducted at participants' schools. Also, parents will be asked to complete a questionnaire assessing children's behaviours at home and schools at 3 time points.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- The University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 6- 12
- Studying in Grade 1 to 6 in mainstream primary schools in Hong Kong
Exclusion Criteria:
- Inability to answer the first five questions in Raven's Progressive Matrices
- Hearing, visual, or physical impairments that might hinder participation in the training and assessment activities
- Current participation in a computerized cognitive treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CogniFit Group
The CogniFit training group will receive 24 sessions of training, 35 - 40 minutes each, conducted three times per week over a period of 8 weeks.
Participants will be asked to complete a set of computerized tasks using CogniFit, a digital training programme which is proven to enhance cognitive ability of participants.
|
In the CogniFit Computerized Cognitive Training, children will complete a range of tasks covering a range of game-like exercises targeting various cognitive skills, including working memory, attention, and inhibitory control, with automatic level advancement after each exercise.
|
|
Active Comparator: Cogmed Group
The Cogmed training group will receive 24 sessions of training, 35 - 40 minutes each, conducted three times per week over a period of 8 weeks.
Participants will be asked to complete a set of computerized tasks using Cogmed, a digital training programme which is proven to enhance working memory and attentional control of participants.
|
In the Cogmed Computerized Cognitive Training, children will complete a range of tasks covering a range of game-like exercises targeting various cognitive skills, including working memory and attentional control, with automatic level advancement after each exercise.
|
|
No Intervention: Waitlist Control Group
The waitlist control group will not receive any intervention until the intervention arms complete their training.
After completion of the assessment at Timepoint 3, Computerized Cognitive Training will be offered to this group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Executive Functiong - Conners Continuous Performance Test 3rd Edition (CPT 3)
Time Frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
|
A standardized computerized test on sustained attention and inhibitory control
|
Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
|
|
Executive Functiong - Conners Continuous Performance Test 3rd Edition (CPT 3)
Time Frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
|
A standardized computerized test on sustained attention and inhibitory control
|
Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
|
|
Executive Functiong - Conners Continuous Performance Test 3rd Edition (CPT 3)
Time Frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
|
A standardized computerized test on sustained attention and inhibitory control
|
Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
|
|
Executive Function - Number subtest of Children's Memory Scale (CMS)
Time Frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
|
A verbal working memory test using digit span, with a higher score indicating a higher level of verbal working memory.
The total score of this test ranges from 0 to 30.
|
Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
|
|
Executive Function - Number subtest of Children's Memory Scale (CMS)
Time Frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
|
A verbal working memory test using digit span, with a higher score indicating a higher level of verbal working memory.
The total score of this test ranges from 0 to 30.
|
Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
|
|
Executive Function - Number subtest of Children's Memory Scale (CMS)
Time Frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
|
A verbal working memory test using digit span, with a higher score indicating a higher level of verbal working memory.
The total score of this test ranges from 0 to 30.
|
Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioural ratings on children's executive functions
Time Frame: Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
|
Parents' report of Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2) measuring a range of executive functions, including behavioural, emotional and cognitive regulation
|
Pre-intervention Assessment (within 4 weeks before the commencement of the intervention)
|
|
Behavioural ratings on children's executive functions
Time Frame: Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
|
Parents' report of Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2) measuring a range of executive functions, including behavioural, emotional and cognitive regulation
|
Immediate Post-intervention Assessment (within 4 weeks after the completion of the intervention)
|
|
Behavioural ratings on children's executive functions
Time Frame: Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
|
Parents' report of Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2) measuring a range of executive functions, including behavioural, emotional and cognitive regulation
|
Delayed Post-intervention Assessment (a 2-month follow up after the completion of the intervention)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EA240316
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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