Effectiveness of the Quotient® ADHD Assessment in a System of Care
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 207
- 试验地点
- 6
- 主要终点
- Number of Participants With 25% Reduction in SNAP Scores
研究概览
简要总结
The study goal is to examine whether the use of an objective computerized neuroassessment (the Quotient System) for Attention-Deficit/Hyperactivity Disorder (ADHD) is related to improved outcomes among pediatric patients being assessed and treated for ADHD.
详细描述
This study is a randomized, controlled trial using a 2-phase data collection. The first phase is the initial assessment for ADHD and includes all patients eligible to be assessed for ADHD as determined by their clinician in the course of usual care. The baseline measurements will be used to compare groups at baseline, and also for longitudinal analyses of medication management. Patients are randomized at this point. Patients in both treatment arms who then receive an ADHD diagnosis and who start medication for ADHD will be eligible for the second phase of the study: three follow-up assessments over six months. Patients who do not have an ADHD diagnosis will not continue in the study, and will be treated by their clinician as usual.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients within the specified age range who are English speaking and who are presenting for ADHD assessment are eligible. An additional criterion is consent to be randomized.
排除标准
- •Non English speaking
- •Refusal to participate
研究组 & 干预措施
Usual Care
Usual clinic ADHD care
干预措施: Usual Clinic ADHD Care (Behavioral)
Usual Care plus Assessment
Usual clinic ADHD care plus the Quotient®
干预措施: Quotient® (Device)
结局指标
主要结局
Number of Participants With 25% Reduction in SNAP Scores
时间窗: One month, 3 month and six month follow ups
Outcome measure reported is the number of participants with at least one 25% reduction in SNAP between visits. In treatment of ADHD, the therapeutic dose is defined as a 25% reduction in SNAP IV score between consecutive clinic visits. SNAP is itemized rating scale (Swanson, Nolan, and Pelham-IV Questionnaire) designed to measure ADHD symptoms and severity on a 4 point scale. It is based on DSM IV criteria, and is designed to measure attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) symptoms in children and young adults ages 6-18.
次要结局
- Satisfaction With Care(Six months)
- Other Health Services Use(Baseline to six months)
- ADHD Symptomatology(6 months post baseline)
- Academic Performance(Baseline and Six Months)
- Persistence in Care(Baseline to Six Months)
- Medication Adherence(Baseline to six months)