Department of Psychology, University of Oslo, Norway; Lovisenberg Diaconal Hospital, Nic Waals Institute, Oslo, Norway.
Department of Psychology, University of Oslo, Norway; Department of Research, Lovisenberg Diaconal Hospital, Norway.
Contemp Clin Trials. 2024 Jan;136:107404. doi: 10.1016/j.cct.2023.107404. Epub 2023 Dec 7.
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.
注意力缺陷多动障碍(ADHD)是儿童和青少年时期最常见的神经发育障碍之一。除了常见的注意力不集中、多动和冲动等症状外,ADHD 患者通常还存在执行功能(EFs)损伤。目标管理训练(GMT)是一种针对 EFs 的认知矫正干预措施,已有针对成年 ADHD 患者的研究提供了实证支持。本研究旨在评估 GMT 对青少年 ADHD 患者的有效性。
本预注册方案概述了一项多中心随机对照试验(RCT),比较 GMT 与常规治疗(TAU)对改善 EFs 的效果。我们计划招募 120 名年龄在 12 至 18 岁之间、新近诊断为 ADHD 的参与者。参与者将通过区组随机化和分层随机化,被随机分配到基于小组的 GMT 干预组(同时接受 TAU)或 TAU 组。GMT 将以每周两次、每次两小时的方式进行,共七周,同时还将提供单独的家长和教师课程。TAU 为标准社区心理健康治疗。主要结局指标为父母报告的执行功能,采用行为评定量表修订版 2(BRIEF-2)评估。次要结局指标包括 ADHD 症状评估、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、工作记忆和视动速度)。在基线、12 周、12 个月和 24 个月治疗后进行结局评估。
研究结果将有助于确定非药物 ADHD 治疗的有效性,包括治疗后 24 个月的结局轨迹。