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

ADHD Clinical Trial

Official title:

Working Memory Training for Preschoolers at Risk of ADHD and Training Effects on Time Perception, ADHD Symptoms, and Academic Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05162729
• Other study ID #: EA210224
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: March 2023
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD
• Social Skills
• Working Memory

Intervention

Behavioral:
• Game-like online working memory training
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 training
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.

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 weeks, immediately after the intervention
Primary	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.	before the intervention
Primary	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.	5 weeks, immediately after the intervention
Primary	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.	before the intervention
Primary	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.	before the intervention
Primary	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.	5 weeks, immediately after the intervention
Primary	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.	before the intervention
Primary	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.	5 weeks, immediately after the intervention
Primary	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.	before the intervention
Primary	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.	5 weeks, immediately after the intervention
Primary	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.	before the intervention
Primary	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.	5 weeks, immediately after the intervention
Primary	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.	before intervention
Primary	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.	5 weeks, immediately after the intervention
Primary	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.	5 weeks, immediately after the intervention
Primary	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.	before the intervention
Secondary	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.	before the intervention
Secondary	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.	5 weeks, immediately after the intervention
Secondary	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.	before the intervention
Secondary	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.	5 weeks, immediately after the intervention
Secondary	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.	before the intervention
Secondary	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.	5 weeks, immediately after the intervention
Secondary	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.	before the intervention
Secondary	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.	5 weeks, immediately after the intervention