Assessment of ARVO Web-based Software for Evaluating Attention-Deficit/Hyperactive Disorder (ADHD) Symptoms in Children. Prospective, Controlled Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- ARVO and CPT 3 neuropsychiatric indicators (NPIs)
研究概览
简要总结
Clinical investigation is aimed to assess the performance and safety of web-based ARVO 2.0, for evaluating possible Attention-Deficit/Hyperactive Disorder (ADHD) symptoms in children. Possible ADHD symptoms are recorded by using specific predetermined neurocognitive performance indicators (NPI's), derived during/from the game.
Results of ARVO are compared to the Conners Continuous Performance Test 3rd Edition™ (CPT 3) that is a task-oriented, automated 14-minute computerized assessment of attention-deficit (AD) related problems in individuals aged 8 years and older.
Performance and safety of ARVO and CPT 3 are compared in two clinical investigation populations, 8-13 years old ADHD children and typically developing (TD) children of the same age. Test are performed by the subject while monitoring adult supervises safety of the use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The Inclusion criteria:
- •Signed informed consent (by guardian and a child)
- •Age of 8-13 at the time of consent
- •ADHD set by a licensed physician
- •Native language Finnish / Fluent Finnish language
- •The Inclusion criteria:
- •Signed informed consent (by guardian and child)
- •Age of 8-13 at the time of the consent
- •Native language Finnish / Fluent Finnish language
排除标准
- •Any diseases of the nervous system (ICD-10, G00-G99)
- •Mental and behavioural disorders due to psychoactive substance use (F10-F19)
- •Schizophrenia, schizotypal and delusional disorders (F20 - F29)
- •Acute severe depression or mania / hypomania (F30, F32, F33)
- •Phobic anxiety disorders, other anxiety disorders, obsessive-compulsive disorder (F40-F42)
- •Severe mental retardation (F72)
- •Disorders of psychological development (F80, F81, F83, F84)
- •Medication taken for ADHD (methylphenidate, lisdexamfetamine) on the test day (24 hour wash out)
- •Atomoxetine, guanfacine
- •Hearing or vision diagnosis (H90 Bilateral hearing loss, H53 Visual disturbances, H54 Blindness and low vision) Diagnosis search completeness criteria: Diagnosis present/absent in patient registry Kanta.
- •Set ADHD diagnosis.
- •Ongoing process related to setting an ADHD diagnosis, according to guardian's questionnaire.
- •Any diseases of the nervous system (ICD-10, G00-G99)
- •Mental and behavioural disorders due to psychoactive substance use (F10-F19)
- •Schizophrenia, schizotypal and delusional disorders (F20 - F29)
- •Acute severe depression or mania / hypomania (F30, F32, F33)
- •Phobic anxiety disorders, other anxiety disorders, obsessive-compulsive disorder (F40-F42)
- •Severe mental retardation (F72)
- •Disorders of psychological development (F80, F81, F83, F84)
- •Hearing or vision diagnosis (H90 Bilateral hearing loss, H53 Visual disturbances, H54 Blindness and low vision)
研究组 & 干预措施
TD
Children of 8-13 years of age without any neuropsychiatric diagnose (typically developed)
干预措施: ARVO 2.0 WEB (Device)
TD
Children of 8-13 years of age without any neuropsychiatric diagnose (typically developed)
干预措施: Conners Continuous Performance Test 3rd Edition™ (CPT 3) (Other)
ADHD
Children of 8-13 years of age with previously diagnosed ADHD symptoms
干预措施: ARVO 2.0 WEB (Device)
ADHD
Children of 8-13 years of age with previously diagnosed ADHD symptoms
干预措施: Conners Continuous Performance Test 3rd Edition™ (CPT 3) (Other)
结局指标
主要结局
ARVO and CPT 3 neuropsychiatric indicators (NPIs)
时间窗: At Visit 1 test event (four weeks after V0 enrollment)
To confirm that ARVO is equivalent to (CPT 3) regarding predictive validity (AUC)
Children SSQ score
时间窗: At Visit 1 (four weeks after V0 enrollment) immediately upon completed ARVO test
To confirm that ARVO is safe as defined by Simulator Sickness Score (SSQ) value 0, 1, or 2.
次要结局
- ARVO and CPT 3 neuropsychiatric indicators (NPIs)(Visit 1 test event (four weeks after V0 enrollment))
- Smileyometer and Fun Sorter(Visit 1 test event (four weeks after V0 enrollment))
- ARVO NPIs mean score and ADHR-RS for parent score(Visit 1 test event (four weeks after V0 enrollment))