- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05162729
Working Memory and Social-emotional Training for Preschoolers at Risk of ADHD
Working Memory Training for Preschoolers at Risk of ADHD and Training Effects on Time Perception, ADHD Symptoms, and Academic Performance
The study aims to explore the effectiveness of working memory training and social emotional training for young children with ADHD in Hong Kong. This study will contribute to the current understanding of the alternative treatments for ADHD, and hopefully help to mobilize more resources to be dedicated to the support of children with ADHD. The programme includes the following components:
Children participating in this study will be randomly allocated into experimental group - recieving working memory training, active control group - receiving social-emotional training, and waitlist control group. All participants will complete a 5-week online training using a digital device at home, three times a week, each training session lasts for about 15 minutes.
Moreover, children's cognitive abilities and academic performance will be assessed prior to the intervention, and immediately after the 5-week training. Each assessment session lasts for about 45 minutes. Parents will also be asked to fill out a questionnaire on children's behaviours at home and school prior to and after the 5-week program. It takes about no more than 10 minutes. All assessments will be conducted at the laboratory at the University of Hong Kong.
Children's working memory, time perception, ADHD symptoms, and early academic performance will be measured before and after training, and the between-group performance will be compared to examine the training effects.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Hong Kong, Hong Kong
- University of Hong Kong
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- children aged 4-6 years old
- with psychiatrist or psychologist diagnosis of ADHD according to the DSM-5 manual or other clinical diagnosis criteria;
- or as indicated by the ratings of Swanson, Nolan and Pelham Parent Rating Scale (SNAP-IV; Chinese version);
- with normal IQ (above 80), which enable them to understand the materials delivered in the training program;
- children either not taking any medication or taking a stable dosage of medication for ADHD for at least 3 months prior to the study enrollment and will not be taking the medication during the training and post-assessment period.
Exclusion Criteria:
- inability to comprehend Cantonese, with comorbid disorders (i.e. autism, conduct/behavioural problems),
- with medical or other mental health condition
- with IQ below 80
- with physical and motor disabilities that restrain them from completing the tasks.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Working memory intervention group
Receive game-like working memory online training for 5 weeks, 3 times per week, each lasting for15 minutes.
|
Participants in the WM group will be receiving two types of WM training tasks (two mini-games) in each session.
Half of the training time will be spent on playing a game that requires visual-spatial WM, and the other half of the training time will be spent on playing a game that demands verbal WM.
In both the games, the participant is asked to remember the pictures or audios (numbers) presented, and then recall them and select them on the screen.
|
Active Comparator: Social emotional intervention group
Receive game-like social-emotional online training for 5 weeks, 3 times per week, each lasting for 15 minutes.
|
Participants in the SE group will be also receiving two types of SE training tasks in each session, to match with the ones in the WM training. There are two mini-games for training. To match with the spatial-visual WM training, participants in the SE group will be asked to first look at a picture that depicts a daily social scenario (i.e., a child who fell down and hurt himself), and then to choose an emotion that the child in the picture may feel from four options of facial emotions displayed on the screen. The other mini-game, with the aim to match with the auditory WM training, will first tell a short story of a social scenario (i.e. "David accidentally fell down and got hurt), and then will ask the child to choose the emotion that the character in the story may feel from the four options displayed on the screen. Each mini game lasts for about 7 minutes in each training session. |
No Intervention: Control group
Receive no training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time perception: time discrimination
Time Frame: before the intervention
|
A computerized task that examined participants' abilities in discriminating discrepancy between different durations of time (Gooch et al., 2011).
A threealternative forced-choice (oddball) paradigm was used.
On each trial, the child heard three 1000Hz tones, two of which were 1200ms long and a roving target which was at a different length (400ms, 700ms, and 1100ms - each repeated nine times).
The child was required to choose which interval was "different" from the other two.
Six easy trials of 100ms comparing with 1200ms were incorporated randomly during the experiment to evaluate the attention level of the participants.
|
before the intervention
|
Time perception: time discrimination
Time Frame: 5 weeks, immediately after the intervention
|
A computerized task that examined participants' abilities in discriminating discrepancy between different durations of time (Gooch et al., 2011).
A threealternative forced-choice (oddball) paradigm was used.
On each trial, the child heard three 1000Hz tones, two of which were 1200ms long and a roving target which was at a different length (400ms, 700ms, and 1100ms - each repeated nine times).
The child was required to choose which interval was "different" from the other two.
Six easy trials of 100ms comparing with 1200ms were incorporated randomly during the experiment to evaluate the attention level of the participants.
|
5 weeks, immediately after the intervention
|
Time perception: time reproduction
Time Frame: before the intervention
|
A computerized lightbulb game was used to measure participants' abilities in recognizing and producing a designated period.
The task was adapted from a similar task developed by Gooch and colleagues (2011).
It was presented in a computer-game-like format where the child was asked to look at the red lightbulb that would appear on the screen and remember how long it had been left on (3s, 5s, 6s, 9s, 12s, and 15s).
After, the child was asked to reproduce for the same length of duration.
Immediately following this presentation the screen went blank and the participant was asked to "turn the yellow lightbulb on and leave it on" (use "ENTER" to turn on) for the same amount of time as it had been for the red lightbulb, and then use "SPACE" to turn off the light.
Each target duration is presented twice in a randomized order for a total of 12 trials.
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before the intervention
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Time perception: time reproduction
Time Frame: 5 weeks, immediately after the intervention
|
A computerized lightbulb game was used to measure participants' abilities in recognizing and producing a designated period.
The task was adapted from a similar task developed by Gooch and colleagues (2011).
It was presented in a computer-game-like format where the child was asked to look at the red lightbulb that would appear on the screen and remember how long it had been left on (3s, 5s, 6s, 9s, 12s, and 15s).
After, the child was asked to reproduce for the same length of duration.
Immediately following this presentation the screen went blank and the participant was asked to "turn the yellow lightbulb on and leave it on" (use "ENTER" to turn on) for the same amount of time as it had been for the red lightbulb, and then use "SPACE" to turn off the light.
Each target duration is presented twice in a randomized order for a total of 12 trials.
|
5 weeks, immediately after the intervention
|
Time perception: time production
Time Frame: before the intervention
|
Subjects were required to indicate the end of 3, 5, 12, and 20-s intervals (each produced twice) by saying "STOP" to indicate the end of the temporal duration.
|
before the intervention
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Time perception: time production
Time Frame: 5 weeks, immediately after the intervention
|
Subjects were required to indicate the end of 3, 5, 12, and 20-s intervals (each produced twice) by saying "STOP" to indicate the end of the temporal duration.
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5 weeks, immediately after the intervention
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nonverbal working memory(CMS - picture location)
Time Frame: before the intervention
|
The picture location subtest from the Children Memory Scale (Cohen, 1997) was used to test participants' non-verbal working memory.
Children were asked to look at pictures on a page for 2 seconds and to recall and indicate the pictures' locations by putting chips on the right places that matched the positions of the pictures showed.
A score was given when the participant successfully matched the correct position of a picture.
The raw score scale ranges from 0 to 30.
A higher score indicates a better nonverbal working memory.
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before the intervention
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non-verbal working memory(CMS - picture location)
Time Frame: 5 weeks, immediately after the intervention
|
The picture location subtest from the Children Memory Scale (Cohen, 1997) was used to test participants' non-verbal working memory.
Children were asked to look at pictures on a page for 2 seconds and to recall and indicate the pictures' locations by putting chips on the right places that matched the positions of the pictures showed.
A score was given when the participant successfully matched the correct position of a picture.The raw score scale ranges from 0 to 30.
A higher score indicates a better nonverbal working memory.
|
5 weeks, immediately after the intervention
|
verbal working memory(CMS-digit span)
Time Frame: before the intervention
|
The number subtest from the Children Memory Scale (Cohen, 1997) was used to measure children's verbal working memory.
The Numbers subtest included both digit span forward and backward tasks, for which the children were asked to recall digit sequences presented verbally in increasing length, either in the same order for Numbers Forward or in the reverse order for Numbers Backward.
The total score was the sum of the scores for the forward and backward tasks.The raw score scale ranges from 0 to 30.
A higher score indicates a better verbal working memory.
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before the intervention
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verbal working memory (CMS- digit span)
Time Frame: 5 weeks, immediately after the intervention
|
The number subtest from the Children Memory Scale (Cohen, 1997) was used to measure children's verbal working memory.
The Numbers subtest included both digit span forward and backward tasks, for which the children were asked to recall digit sequences presented verbally in increasing length, either in the same order for Numbers Forward or in the reverse order for Numbers Backward.
The total score was the sum of the scores for the forward and backward tasks.The raw score scale ranges from 0 to 30.
A higher score indicates a better verbal working memory.
|
5 weeks, immediately after the intervention
|
Emotion situation knowledge measures.
Time Frame: before the intervention
|
This task was developed by Garner et al. (1994) to measure children's ability to infer emotions from situational cues, and similar tasks have been used among preschoolers (Beaudoin et al. 2020; Gallant et al. 2020).
Social situations commonly encountered by children were presented in pictures, with the facial expressions of the target characters left out (i.e., blank faces were shown).
The children were asked to identify the feeling of the target character by either naming the emotion or pointing to the corresponding facial expression out of four options (happy, sad, angry, and afraid) given on the stimulus sheet.
There were two sample items followed by 13 test items.
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before the intervention
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Emotion situation knowledge measures.
Time Frame: 5 weeks, immediately after the intervention
|
This task was developed by Garner et al. (1994) to measure children's ability to infer emotions from situational cues, and similar tasks have been used among preschoolers (Beaudoin et al. 2020; Gallant et al. 2020).
Social situations commonly encountered by children were presented in pictures, with the facial expressions of the target characters left out (i.e., blank faces were shown).
The children were asked to identify the feeling of the target character by either naming the emotion or pointing to the corresponding facial expression out of four options (happy, sad, angry, and afraid) given on the stimulus sheet.
There were two sample items followed by 13 test items.
|
5 weeks, immediately after the intervention
|
Theory of mind (ToM)
Time Frame: before intervention
|
Children's ToM will be measured by the ToM scale developed by Wellman and Liu (2004).
The seven-item scale was designed for the experimental to adminster in order according to the difficulty of the task, with the Diverse Desire task as the easiest, and the Real-Apparent Emotion task as the most difficult.
Participants will receive one point for each task passed successfully(range: 0-7).
A higher score indicates a better ability of ToM.
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before intervention
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Theory of mind (ToM)
Time Frame: 5 weeks, immediately after the intervention
|
Children's ToM will be measured by the ToM scale developed by Wellman and Liu (2004).
The seven-item scale was designed for the experimental to adminster in order according to the difficulty of the task, with the Diverse Desire task as the easiest, and the Real-Apparent Emotion task as the most difficult.
Participants will receive one point for each task passed successfully (range: 0-7).A higher score indicates a better ability of ToM.
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5 weeks, immediately after the intervention
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Working Memory Behavioural Manisfetation
Time Frame: 5 weeks, immediately after the intervention
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The Working Memory Subscale from the BRIEF-P is used to measure participants' daily behavioural manifestation of working memory reported by parents.
The minimum raw score is 0 and maximum score is 17.
A higher score indicates more severe deficits in working memory.
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5 weeks, immediately after the intervention
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Working Memory Behavioural Manisfetation
Time Frame: before the intervention
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The Working Memory Subscale from the BRIEF-P is used to measure participants' daily behavioural manifestation of working memory reported by parents.
The minimum raw score is 0 and maximum score is 17.
A higher score indicates more severe deficits in working memory.
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before the intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ADHD symptoms(SNAP-IV)
Time Frame: before the intervention
|
Swanson, Nolan and Pelham Parent Rating Scale (26 items, SNAP-IV; Chinese version; Gau et al., 2008) will be used to reflect the symptom severity of ADHD behaviors.
The minimum raw score is 0 and maximum is 26.
The higher score indicates a higher symptomatic presentation of ADHD behaviours.
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before the intervention
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ADHD symptoms(SNAP-IV)
Time Frame: 5 weeks, immediately after the intervention
|
Swanson, Nolan and Pelham Parent Rating Scale (26 items, SNAP-IV; Chinese version; Gau et al., 2008) will be used to reflect the symptom severity of ADHD behaviors.
The minimum raw score is 0 and maximum is 26.
The higher score indicates a higher symptomatic presentation of ADHD behaviours.
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5 weeks, immediately after the intervention
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Academic measures - Chinese word reading
Time Frame: before the intervention
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The Hong Kong Reading Ability Screening Test for Preschool Children (RAST-K) will be used to measure participants' Chinese word reading ability.
The maximum score is 55 and the minimum is 0. The higher score indicates a better Chinese word reading ability.
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before the intervention
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Academic measures - Chinese word reading
Time Frame: 5 weeks, immediately after the intervention
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The Hong Kong Reading Ability Screening Test for Preschool Children (RAST-K) will be used to measure participants' Chinese word reading ability.
The maximum score is 55 and the minimum is 0. The higher score indicates a better Chinese word reading ability.
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5 weeks, immediately after the intervention
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Academic measures - English word reading
Time Frame: before the intervention
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An adapted English word reading assessment designed by the experimenters will be implemented to measure participants' English word reading ability.
The maximum score is 55, and the minimum score is 0. A higher score indicates a higher ability of English word reading.
|
before the intervention
|
Academic measures - English word reading
Time Frame: 5 weeks, immediately after the intervention
|
An adapted English word reading assessment designed by the experimenters will be implemented to measure participants' English word reading ability.
The maximum score is 55, and the minimum score is 0. A higher score indicates a higher ability of English word reading.
|
5 weeks, immediately after the intervention
|
Academic measures - Numeration
Time Frame: before the intervention
|
The numeration subscale from Keymath-3 Diagnostic Assessment (Connolly, 2014) will be used to measure their number skills.
The maximum score is 49 and the minimum score is 0. A higher score indicates a higher ability in numeration.
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before the intervention
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Academic measures - Numeration
Time Frame: 5 weeks, immediately after the intervention
|
The numeration subscale from Keymath-3 Diagnostic Assessment (Connolly, 2014) will be used to measure their number skills.
The maximum score is 49 and the minimum score is 0. A higher score indicates a higher ability in numeration.
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5 weeks, immediately after the intervention
|
Collaborators and Investigators
Sponsor
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
- EA210224
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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