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Completed

NCT Number: NCT06181747

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Normal University, Nanjing, Jiangsu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

a serious mobile device-based game prototype (Save the Muse Home)

Device

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.

Primary outcomes

  1. Continuous Performance Test, CPT

    Time frame: baseline and post (an average of 30days after baseline)

    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.

Secondary outcomes

  1. Swanson Nolan, and Pelham-IV rating scales, SNAP-IV

    Time frame: baseline and post (an average of 30days after baseline)

    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.

  2. Strengths and Difficulties Questionnaire, SDQ

    Time frame: baseline and post (an average of 30days after baseline)

    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.

  3. Behavior Rating Inventory of Executive Function, BRIEF

    Time frame: baseline and post (an average of 30days after baseline)

    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.

  4. Anti-saccade task

    Time frame: baseline and post (an average of 30days after baseline)

    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.

  5. Delay-saccade task

    Time frame: baseline and post (an average of 30days after baseline)

    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.

Sponsors and collaborators

Lead sponsor

Institute of Psychology, Chinese Academy of Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 26, 2023
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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