AzTrials
AzTrials

ADHDNCT05162729

Working Memory and Social-emotional Training for Preschoolers at Risk of ADHD

A study testing Game-like online working memory training and Game-like online social emotional training in people with ADHD and Time Perception Altered, run by The University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 4 to 6 yearsHealthy volunteers can take part
Conditions the study is for
ADHD, Time Perception Altered, Working Memory
What is being tested?
Game-like online working memory training and Game-like online social emotional training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
1 siteHong Kong
Study dates
1 Sep 2021to 1 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: 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.

Read more

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.

Being tested
Game-like online working memory training, Game-like online social emotional training
Keywords
preschool, ADHD, working memory
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Social Skills

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Game-like online working memory trainingBehavioural

    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.

  • Game-like online social emotional trainingBehavioural

    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.

Study groups in NCT05162729
Study groupRoleWhat they receive
Working memory intervention groupExperimentalReceive game-like working memory online training for 5 weeks, 3 times per week, each lasting for15 minutes.
Receives: Behavioral: Game-like online working memory training
Social emotional intervention groupActive comparatorReceive game-like social-emotional online training for 5 weeks, 3 times per week, each lasting for 15 minutes.
Receives: Behavioral: Game-like online social emotional training
Control groupNo interventionReceive no training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. verbal working memory (CMS- digit span)

    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.

    Measured: 5 weeks, immediately after the intervention

  2. verbal working memory(CMS-digit span)

    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.

    Measured: before the intervention

  3. non-verbal working memory(CMS - picture location)

    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.

    Measured: 5 weeks, immediately after the intervention

  4. nonverbal working memory(CMS - picture location)

    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.

    Measured: before the intervention

  5. Time perception: time discrimination

    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.

    Measured: before the intervention

  6. Time perception: time discrimination

    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.

    Measured: 5 weeks, immediately after the intervention

  7. Time perception: time reproduction

    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.

    Measured: before the intervention

  8. Time perception: time reproduction

    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.

    Measured: 5 weeks, immediately after the intervention

  9. Time perception: time production

    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.

    Measured: before the intervention

  10. Time perception: time production

    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.

    Measured: 5 weeks, immediately after the intervention

  11. Emotion situation knowledge measures.

    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.

    Measured: before the intervention

  12. Emotion situation knowledge measures.

    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.

    Measured: 5 weeks, immediately after the intervention

  13. Theory of mind (ToM)

    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.

    Measured: before intervention

  14. Theory of mind (ToM)

    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.

    Measured: 5 weeks, immediately after the intervention

  15. Working Memory Behavioural Manisfetation

    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.

    Measured: 5 weeks, immediately after the intervention

  16. Working Memory Behavioural Manisfetation

    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.

    Measured: before the intervention

Secondary outcomes (8)
  1. ADHD symptoms(SNAP-IV)

    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.

    Measured: before the intervention

  2. ADHD symptoms(SNAP-IV)

    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.

    Measured: 5 weeks, immediately after the intervention

  3. Academic measures - Chinese word reading

    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.

    Measured: before the intervention

  4. Academic measures - Chinese word reading

    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.

    Measured: 5 weeks, immediately after the intervention

  5. Academic measures - English word reading

    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.

    Measured: before the intervention

  6. Academic measures - English word reading

    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.

    Measured: 5 weeks, immediately after the intervention

  7. Academic measures - Numeration

    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.

    Measured: before the intervention

  8. Academic measures - Numeration

    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.

    Measured: 5 weeks, immediately after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2021
  2. Study start1 Sep 2021
  3. Primary completion1 Apr 2022
  4. Study completion1 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Intervention group: receive 5 weeks working memory online training, three times per week, each lasts 15 minutes. Active control group: receive 5 weeks social-emotional online training, three times per week, each lasts 15 minutes. Control group: no training
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05162729
Sponsor's protocol ID
EA210224
Status last verified
Mar 2023
First submitted
2 Nov 2021
Last updated
28 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Game-like online working memory training and Game-like online social emotional training in people with ADHD and Time Perception Altered, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

verbal working memory (CMS- digit span) (time frame: 5 weeks, immediately after the intervention). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in