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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06181747
• Other study ID #: E2KM011639-K12023000015
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: May 10, 2023

Study information

• Verified date: November 2023
• Source: Institute of Psychology, Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 10, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity

Intervention

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.

Locations

Country	Name	City	State
China	Institute of Psychology, Chinese Academy of Sciences	Beijing
China	Nanjing Normal University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Psychology, Chinese Academy of Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)