NCT03437772已完成不适用
Third Generation Cognitive Behavioural Therapy Versus Treatment-as-usual for Attention Deficit and Hyperactivity Disorder: a Randomized, 2-parallel-group, Evaluator Blinded, Superiority Trial
Centre Hospitalier Universitaire de Nīmes4 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2018年2月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 248
- 试验地点
- 4
- 主要终点
- ADHD symptom severity
研究概览
简要总结
The investigators hypothesize that the mindfulness Cognitive Behavioral Therapy program will lead to a reduction in attention deficit and hyperactivity disorder symptoms, anxiety and depression, and improve self-confidence, emotional control, social integration and school results.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If deemed able, the patient must have given his/her informed and signed consent
- •The parents (or legal guardian) of minor patients must have given their informed and signed consent.
- •The patient and participating parents must be insured or beneficiary of a health insurance plan
- •The patient is equal to or greater than 7 years old and less than or equal to 15 years old
- •The patient presents with attention deficit and hyperactivity disorder with an ADHDRS-PI score > 27
- •The patient is currently not under treatment - OR - is treated with methylphenidate with a stable posology (not expected to vary in the near future) but remains symptomatic
排除标准
- •The patient is participating in, or has participated in over the past three months, another trial or another study that may interfere with the results or conclusion of the present study
- •The patient is in an exclusion period determined by a previous study
- •The participating parent(s) is(are) under judicial protection, or is an adult under guardianship
- •It is impossible to correctly inform the patient or his/her parent or legal guardian
- •Patients or parents refusing participation, signature of the signed consent or follow-up procedures
- •Previously documented mental retardation (IQ < 70) or suspicion thereof by the investigator
- •The patient has already participated in cognitive behavioural therapy (individual or group) in the six months preceding inclusion
- •Patients diagnosed with autism spectrum disorder, psychotic disorder or bipolar disorder
- •The family has participated in a parental guidance programme in the last 6 months.
- •The family has already participated in the present study
结局指标
主要结局
ADHD symptom severity
时间窗: Month 8
clinical-rated ADHD rating scale (ADHDRS-PI) questionnaire; score ranges 0-54
次要结局
- Social well-being and school parameters for children(Month 8)
- Anxiety and depression in parents(Month 8)
- Anxiety in children(Month 8)
- Parenting styles(Month 8)
- The quality of life for parents.(Month 8)
- Global function(Month 8)
- Depression in children(Month 8)
- Self-Esteem and behaviour for children.(Month 8)
研究者
研究点 (4)
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