ChiCTR1800014741招募中Unknown
The effects of a mindfulness based intervention - MYmind - for children with ADHD and their parents: a randomised controlled trial
General Research Fund, University Grants Committee, Hong Kong SAR1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2018年1月1日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- The attention score of the subtest Sky Search of TEA-Ch (for children)
研究概览
简要总结
- To evaluate the effectiveness of a mindfulness based intervention - MYmind - in improving childrens attention, behaviour and executive function as well as reducing impulsivity associated with ADHD in children diagnosed with ADHD aged 8 to 12 years in Hong Kong;
- To evaluate the effectiveness of MYmind in reducing parental stress and ADHD symptoms and improving well-being and parenting style among parents of children diagnosed with ADHD;
- To further evaluate the acceptability of MYmind for children diagnosed with ADHD and their parents in Hong Kong Chinese.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- The research staff member who conducts the assessments or statistical analysis will be kept blinded of the group assignment.
入排标准
- 年龄范围
- 8 至 100（—）
- 性别
- All
入选标准
- •children aged 8 to 12 years with psychiatrist or psychologist diagnosed ADHD according to the Diagnostic and Statistical Manual of Mental Disorders - 5 (DSM-5) diagnostic criteria and ADHD status being re-confirmed by clinically elevated inattentive and/or hyperactive-impulsive symptoms as indicated by T-scores of either parent and teacher versions of Strengths and Weaknesses of ADHD-symptoms and Normal-behaviour (SWAN, Chinese version) at or above 95th percentile, or both parent and teacher versions of the SWAN (Chinese version) at or above 85th percentile;
- •with normal intellectual ability such that they can understand the materials delivered in MYmind and that they can complete home practice each week;
- •children either not taking any medication or taking a stable dosage of the same medication for ADHD for at least 3 months prior to study enrolment and having no plan for changing medication during the study period.
排除标准
- •The exclusion criteria of children and parents are:
- •being unable to communicate and understand Chinese language as the intervention will be conducted in Chinese;
- •the child having comorbid conduct/behavior problems which are so severe that, during intake, the interaction between parent and clinician is interrupted by the child within 2 minutes, which makes it impossible for the child to participate in a group training. Instructions of this criterion are adapted from the Autism Diagnostic Observation Schedule (ADOS) and will be provided to the clinician to facilitate to examine whether the child may be or may not be able to participate in a group training in addition to the clinicians expertise;
- •having a medical or mental health condition rendering him/her to be incapable of participating in the study;
- •previous participation in mindfulness-based training.
研究组 & 干预措施
1
Mindfulness-based Intervention (MYmind)
2
Cognitive Behavioral Therapy (CBT)
结局指标
主要结局
The attention score of the subtest Sky Search of TEA-Ch (for children)
时间窗: baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3)
次要结局
- Creature Counting, Opposite Worlds, and Code Transmission subtests of TEA-Ch (for children)(baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3))
- Child attention network test (ANT) (for children)(baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3))
- The Strengths and Weaknesses of ADHD Symptoms and Normal Behaviours (SWAN) Rating Scale (for children)(baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3))
- The Eyberg Child Behaviour Inventory (ECBI) (for children)(baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3))
- The Behavior Rating Inventory of Executive Function (BRIEF) (for children)(baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3))
- Parenting Stress Index (PSI) (for parents)(baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3))
- Rumination Response Scale (RRS)(baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3))
- Adult ADHD Self-Report Scale (ASRS) (for parents)(baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3))
- The WHO (Five) Well-Being Index (WHO-5) (for parents)(baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3))
- Child and Adolescent Mindfulness Measure (CAMM)(baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3))
- Perceived levels of easiness, usefulness and satisfaction of the intervention by both children and parents will be collected on a Likert scale of 1-10 representing ‘not easy/helpful/satisfied at all’ to ‘extremely easy/helpful/satisfied’(post intervention)
研究者
研究点 (1)
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