Clinical trial NCT06181747: Development of Attention and Its Relationship With Emotions in Children and Adolescents
Official title: Research on the Development of Attention and Its Relationship With Emotions in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Institute of Psychology, Chinese Academy of Sciences
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Continuous Performance Test, CPT
timeFrame: baseline and post (an average of 30days after baseline)
Secondary outcomes:
measure: Swanson Nolan, and Pelham-IV rating scales, SNAP-IV
timeFrame: baseline and post (an average of 30days after baseline)
measure: Strengths and Difficulties Questionnaire, SDQ
timeFrame: baseline and post (an average of 30days after baseline)
measure: Behavior Rating Inventory of Executive Function, BRIEF
timeFrame: baseline and post (an average of 30days after baseline)
measure: Anti-saccade task
timeFrame: baseline and post (an average of 30days after baseline)
measure: Delay-saccade task
timeFrame: baseline and post (an average of 30days after baseline)
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Normal University
state: Jiangsu
city: Beijing
country: China
facility: Institute of Psychology, Chinese Academy of Sciences
Study officials:
affiliation: Institute of Psychology, Chinese Academy of Sciences
name: Zhengkui Liu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: