Development of Attention and Its Relationship With Emotions in Children and Adolescents

Research on the Development of Attention and Its Relationship With Emotions in Children and Adolescents

Our aim was to describe the development and usability of a mobile device-based game therapy software for ADHD.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Device: a serious mobile device-based game prototype (Save the Muse Home)

Detailed Description

A total of 51 ADHD children and 52 healthy children were included in the study. At baseline, subjects underwent tests such as ADHD symptom-related scale assessments, computer-assisted information processing tests, and physiological-psychological tests, after which participants completed a 4-week game intervention training at home. After complete completion of the intervention, subjects repeated all tests from the baseline period and answered treatment satisfaction questions.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Institute of Psychology, Chinese Academy of Sciences
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing Normal University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ADHD-a. Age between 6-12 years, any gender.
• ADHD-b. Outpatient patients diagnosed with ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
• ADHD-c. Patients and/or their guardians willing to participate in the study and provide informed consent. Participants aged 8 and above should also sign a child's informed consent form.
• HC. The control group of healthy participants are recruited from a secondary school in Nanjing, matching the age and gender of the ADHD group.

Exclusion Criteria:

• a. Neurodevelopmental disorders such as cerebral palsy, epilepsy, adrenoleukodystrophy, and other similar conditions.
• b. Severe mental disorders including tic disorders, autism spectrum disorders, intellectual disability, schizophrenia, bipolar disorder, depressive disorders, specific learning disorders, and other significant psychiatric conditions.
• c. Individuals exhibiting ADHD-like symptoms due to hearing impairments.
• d. Requirement of any central nervous system medication (including both traditional and Western medicine as well as dietary supplements) such as antipsychotics or antidepressants at any stage of the study.
• e. Patients who have received systematic treatment with two different categories of ADHD medications without improvement.
• f. Individuals with color blindness or any other condition that would prevent proper use of the software.
• g. History of or current gaming addiction.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADHD group; Participants are required to engage in game training at home for 5 days per week, with each session lasting 20-25 minutes. The game is equipped with anti-addiction measures, limiting the maximum daily game time to 30 minutes. Participants will adjust their game training based on their own abilities, and as the training progresses, the game will adaptively adjust the difficulty level and change levels accordingly.	Device: a serious mobile device-based game prototype (Save the Muse Home); The cognitive impairment corresponding to the symptoms, which we are interested in, focuses on executive inhibition, motor inhibition, sustained attention, selective attention, working memory, and planning ability. The training content will be presented in different scenarios as effective training components. The story line of the warrior breakthrough runs through the whole game, each level is adapted according to the functional damage areas of different patients, and each level involves reward and punishment mechanisms to keep the interest of the players, the difficulty gradient of each level is kept moderate, and the game includes design elements such as space, time, object attributes, actions, rules, skills, and probabilities, etc., which ultimately completes Save the Muse Home, a serious game for the treatment of ADHD.
Experimental: healthy control group; Participants are required to engage in game training at home for 5 days per week, with each session lasting 20-25 minutes. The game is equipped with anti-addiction measures, limiting the maximum daily game time to 30 minutes. Participants will adjust their game training based on their own abilities, and as the training progresses, the game will adaptively adjust the difficulty level and change levels accordingly.	Device: a serious mobile device-based game prototype (Save the Muse Home); The cognitive impairment corresponding to the symptoms, which we are interested in, focuses on executive inhibition, motor inhibition, sustained attention, selective attention, working memory, and planning ability. The training content will be presented in different scenarios as effective training components. The story line of the warrior breakthrough runs through the whole game, each level is adapted according to the functional damage areas of different patients, and each level involves reward and punishment mechanisms to keep the interest of the players, the difficulty gradient of each level is kept moderate, and the game includes design elements such as space, time, object attributes, actions, rules, skills, and probabilities, etc., which ultimately completes Save the Muse Home, a serious game for the treatment of ADHD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous Performance Test, CPT	CPT software is one of the commonly used tools for examining attention and is a computer-assisted information processing test with objective results, independent of supervisors, and is the most widely used experimental paradigm in current research. The CPT paradigm adopted in this study is the presence of a white boxed area on a black background on the calculator screen, with white squares randomly appearing above or below the white boxed area, requiring the target stimulus to be a right mouse button press when the square appears below it.	baseline and post (an average of 30days after baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swanson Nolan, and Pelham-IV rating scales, SNAP-IV	The SNAP-IV rating scales (Swanson Nolan, and Pelham-IV rating scales, SNAP-IV) is a revised version of the Swanson, Nolan Pelham (SNAP) (Swanson, et al., 1983), which was developed based on the description of ADHD symptoms in the Diagnostic and Statistical Manual of Mental Disorders (DSM). It consists of three subscales: attention deficit, hyperactivity-impulsivity, and oppositional defiance, and is mainly used for screening, diagnostic support, and assessment of treatment efficacy and symptom improvement in children and adolescents between the ages of 6 and 18 years. Although SNAP-IV consists of 3 subscales, it is one scale, just like SDQ and BRIEF mentioned later.	baseline and post (an average of 30days after baseline)
Strengths and Difficulties Questionnaire, SDQ	The SDQ is a brief behavioral screening questionnaire designed and developed by American psychologist Goodman R in 1997 based on the Diagnostic and Statistical Manual of Mental Disorders-IV and the Diagnostic Criteria for the Classification of Mental and Behavioral Disorders, 10th Edition (ICD-10). It is used to assess behavioral and emotional problems in children and adolescents and has good reliability and validity.	baseline and post (an average of 30days after baseline)
Behavior Rating Inventory of Executive Function, BRIEF	The scale consists of 86 entries in two major areas: the Behavior Management Index (BMI), which includes the three subscales of Inhibition, Conversion, and Affect, and Control, Conversion and Affect, and Control subscales; and the Metacognitive Functioning Index: five subscales including Task Initiation, Working Memory, Planning, Organization, and Monitoring. It has good reliability and validity.	baseline and post (an average of 30days after baseline)
Anti-saccade task	First, present the central gaze point cross for 2s, the central cross disappeared while the target appeared as a green dot, randomly present four positions at 3°, 6° left and right sides horizontally, presentation time 1000ms, each angle randomly appeared 5 times for a total of 20 times, when the response is over a 300ms feedback point will appear in the correct position.	baseline and post (an average of 30days after baseline)
Delay-saccade task	Presentation of the central gaze point cross for 2 s, the target stimulus appeared (the cross continued to exist) for the green origin randomly presented at four positions 3°, 6° left and right sides horizontally, presentation time 100 ms. Subsequently, the gaze point was presented only at the center of the screen for 1, 3, and 5 s, staring at the cross intently, and then the screen appeared to go blank for 1.4 s, the subject recalled looking at the beginning of the target, and the latter a 200-ms feedback point appeared at the correct location.	baseline and post (an average of 30days after baseline)

Collaborators and Investigators

• Sponsor: Institute of Psychology, Chinese Academy of Sciences
• Investigators: Principal Investigator: Zhengkui Liu, Ph.D., Institute of Psychology, Chinese Academy of Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): May 5, 2023
• Study Completion (Actual): May 10, 2023

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: E2KM011639-K12023000015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No