ChiCTR1800016591招募中Unknown
A randomised controlled trial comparing MYmind with waitlist control among Chinese children with ADHD and their parents
The D. H. Chen Foundation, 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6月28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 children's attention, well-being, behaviour, resilience, family relationship and mindfulness level as well as reducing impulsivity associated with ADHD and health service use in children diagnosed with ADHD aged 8 to 18 years in Hong Kong.
- To evaluate the effectiveness of MYmind in reducing parental stress and ADHD symptoms and improving well-being and rumination and reducing health service use among parents of children diagnosed with ADHD.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- Participants will be informed of their group assignments. The research staff member who conducts the assessments or the statistical analysis will be kept blinded of the group assignment.
入排标准
- 年龄范围
- 8 至 80（—）
- 性别
- All
入选标准
- •Participants will include children and one parent of each child. However, the other parent of the same child is also welcome to participate in the mindfulness course but only their course attendance will be recorded to reduce the burden of the participating families. The inclusion criteria will be: 1) children aged 8 to 18 years with psychiatrist or psychologist diagnosed ADHD according to the Diagnostic and Statistical Manual of Mental Disorders - 5 (DSM-5) diagnostic criteria; and 2) with normal intellectual ability such that they can understand the materials delivered in MYmind and that they can complete home practice each week; and 3) 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 will be: 1) being unable to communicate and understand Chinese language as the intervention will be conducted in Chinese; 2) the child having comorbid conduct/behavior problems which are so severe that, during intake, the interaction between parent and assessor 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 assessor 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; 3) having a medical or mental health condition rendering him/her to be incapable of participating in the study; and 4) previous participation in mindfulness-based training.
研究组 & 干预措施
1
Mindfulness-based intervention
2
Waiting list control
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 Child and Adolescent Mindfulness Measure (CAMM) (for children)(baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3))
- Child and Youth Resilience Measure (CYRM)(baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3))
- The Child Behaviour Checklist (CBCL)(baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3))
- Family APGAR index(baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3))
- Health service utilization (for children and parents)(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) short form (for parents)(baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3))
- Adult ADHD Self-Report Scale (ASRS)(baseline (T0), post intervention (T1), 3 and 6 month post intervention (T2 & T3))
- Course evaluation(post intervention (T1))
研究者
研究点 (1)
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