Abstract：
Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most prevalent neurodevelopmental conditions diagnosed during childhood and adolescence. In addition to the commonly observed symptoms of inattention, hyperactivity, and impulsivity, individuals with ADHD often experience impairments in executive functions (EFs). Goal management training (GMT) is a cognitive remediation intervention targeting EFs, with empirical support from studies with adult populations, including ADHD. The objective of the upcoming trial is to assess the effectiveness of GMT for adolescents with ADHD.
This pre-registered protocol outlines a multi-centre randomised controlled trial (RCT) comparing GMT to treatment as usual (TAU) to improve EFs. We aim to recruit 120 participants, aged 12 to 18 years, recently diagnosed with ADHD. Participants will be randomly allocated to the group-based GMT intervention in addition to TAU, or the TAU condition, through block randomisation with site stratification. GMT will be delivered in groups of four to six participants, with weekly two-hour sessions for seven weeks, complemented by separate parent and teacher sessions. TAU is standard community mental health treatment. The primary outcome measure will be parent-reported EF assessed with the Behaviour Rating Inventory of Executive Function 2 (BRIEF-2). Secondary outcomes will include ADHD symptom measures, social functioning, quality of life, and neuropsychological tests (attention span, inhibition, working memory, and visuo-motor speed). The outcome assessments will be conducted at baseline, 12 weeks, 12 months, and 24 months post-treatment.
The study findings will contribute to determine the effectiveness of a non-pharmacological ADHD treatment, including outcome trajectories up to 24 months post-treatment.
This pre-registered protocol outlines a multi-centre randomised controlled trial (RCT) comparing GMT to treatment as usual (TAU) to improve EFs. We aim to recruit 120 participants, aged 12 to 18 years, recently diagnosed with ADHD. Participants will be randomly allocated to the group-based GMT intervention in addition to TAU, or the TAU condition, through block randomisation with site stratification. GMT will be delivered in groups of four to six participants, with weekly two-hour sessions for seven weeks, complemented by separate parent and teacher sessions. TAU is standard community mental health treatment. The primary outcome measure will be parent-reported EF assessed with the Behaviour Rating Inventory of Executive Function 2 (BRIEF-2). Secondary outcomes will include ADHD symptom measures, social functioning, quality of life, and neuropsychological tests (attention span, inhibition, working memory, and visuo-motor speed). The outcome assessments will be conducted at baseline, 12 weeks, 12 months, and 24 months post-treatment.
The study findings will contribute to determine the effectiveness of a non-pharmacological ADHD treatment, including outcome trajectories up to 24 months post-treatment.
摘要：
背景：注意缺陷/多动障碍（ADHD）是儿童和青春期诊断出的最普遍的神经发育疾病之一。除了常见的注意力不集中的症状，多动症,和冲动，患有多动症的人经常经历执行功能(EF)受损。目标管理培训(GMT)是一种针对EF的认知补救干预措施，在成人人群研究的经验支持下，包括多动症。即将进行的试验的目的是评估GMT对患有ADHD的青少年的有效性。
方法：该预先注册的方案概述了一项多中心随机对照试验（RCT），将GMT与常规治疗（TAU）进行比较以改善EF。我们的目标是招募120名参与者，12至18岁，最近被诊断出患有多动症。除TAU外，参与者将被随机分配到基于小组的GMT干预中，或TAU条件，通过区组随机化和地点分层。GMT将以四到六名参与者为一组进行，每周两小时，七个星期，由单独的家长和教师会议补充。TAU是标准的社区心理健康治疗。主要结果指标将是父母报告的EF，使用执行功能行为评级清单2（BRIEF-2）进行评估。次要结果将包括ADHD症状测量，社会功能,生活质量,和神经心理学测试(注意力持续时间，抑制,工作记忆,和视觉电机速度)。结果评估将在基线进行，12周,12个月,治疗后24个月。
结论：研究结果将有助于确定非药物治疗ADHD的有效性。包括治疗后24个月的结果轨迹。
方法：该预先注册的方案概述了一项多中心随机对照试验（RCT），将GMT与常规治疗（TAU）进行比较以改善EF。我们的目标是招募120名参与者，12至18岁，最近被诊断出患有多动症。除TAU外，参与者将被随机分配到基于小组的GMT干预中，或TAU条件，通过区组随机化和地点分层。GMT将以四到六名参与者为一组进行，每周两小时，七个星期，由单独的家长和教师会议补充。TAU是标准的社区心理健康治疗。主要结果指标将是父母报告的EF，使用执行功能行为评级清单2（BRIEF-2）进行评估。次要结果将包括ADHD症状测量，社会功能,生活质量,和神经心理学测试(注意力持续时间，抑制,工作记忆,和视觉电机速度)。结果评估将在基线进行，12周,12个月,治疗后24个月。
结论：研究结果将有助于确定非药物治疗ADHD的有效性。包括治疗后24个月的结果轨迹。
