Research on the Development of Attention and Its Relationship With Emotions in Children and Adolescents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 110
- Locations
- 2
- Primary Endpoint
- Continuous Performance Test, CPT
Study Overview
Brief Summary
Our aim was to describe the development and usability of a mobile device-based game therapy software for ADHD.
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: a serious mobile device-based game prototype (Save the Muse Home) (Device)
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.
Intervention: a serious mobile device-based game prototype (Save the Muse Home) (Device)
Outcomes
Primary Outcomes
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
- Delay-saccade task(baseline and post (an average of 30days after baseline))
- Swanson Nolan, and Pelham-IV rating scales, SNAP-IV(baseline and post (an average of 30days after baseline))
- Strengths and Difficulties Questionnaire, SDQ(baseline and post (an average of 30days after baseline))
- Anti-saccade task(baseline and post (an average of 30days after baseline))
- Behavior Rating Inventory of Executive Function, BRIEF(baseline and post (an average of 30days after baseline))