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慢性儿童脑损伤患者执行功能的康复:一项随机对照试验。

Rehabilitation of executive function in chronic paediatric brain injury: a randomized controlled trial.

机构信息

Children's Clinic, St. Olavs Hospital, Trondheim University Hospital, Postbox 3250 Torgarden, NO-7006, Trondheim, Norway.

Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway.

出版信息

BMC Med. 2021 Nov 2;19(1):253. doi: 10.1186/s12916-021-02129-8.

Abstract

BACKGROUND

Impaired executive functions (EFs, i.e., purposeful, goal-directed behaviour) cause significant disability after paediatric acquired brain injury (pABI) warranting efficient interventions. Goal Management Training (GMT) is a metacognitive protocol proven effective for executive dysfunction in adults. This pre-registered, blinded, parallel-randomized controlled trial evaluated efficacy of a paediatric adaptation (pGMT) compared to a psychoeducative control (paediatric Brain Health Workshop, pBHW) to improve EF.

METHODS

Children aged 10 to 17 years with pABI (e.g., traumatic brain injury, brain tumour), ≥ 1 year post-onset or ended treatment, with parent-reported EF complaints were eligible. Participants were randomized (computer-algorithm) to either group-based pGMT (n = 38) or pBHW (n = 38). The active control was tailored to keep non-specific factors constant. Thus, both treatments comprised of 7 sessions at hospitals over 3 consecutive weeks, followed by 4 weeks of telephone counselling of participants, parents, and teachers. Parent-reported daily life EF, assessed by the questionnaire Behavior Rating Inventory of Executive Function (BRIEF; Behavioral Regulation Index (BRI) and Metacognition Index (MI)), were co-primary outcomes 6 months post-intervention. Secondary outcomes included neuropsychological tests and a complex naturalistic task (Children's Cooking Task).

RESULTS

Seventy-three participants (96%) completed allocated interventions and 71 (93%) attended the 6-month follow-up. The results demonstrated no significant difference in effectiveness for the two interventions on parent-reported EF: For BRIEF, mean (SD) raw score for pGMT was 42.7 (8.8) and 38.3 (9.3) for pBHW. Estimated difference was - 2.3 (95% CI - 5.1 to 0.6). For BRIEF, the corresponding results were 80.9 (20.4) for GMT and 75.5 (19.3) for pBHW. Estimated difference was - 1.4 (95% CI -8.5 to 5.8). In performance-based tests, pGMT was associated with improved inhibition and executive attention, while pBHW was associated with fewer errors in the naturalistic task.

CONCLUSIONS

In pABI, metacognitive training (pGMT) did not demonstrate additional effectiveness on parent-reported daily life EF at 6-month follow-up, when compared to a psychoeducative control. Both interventions were well-tolerated and demonstrated distinct improvements at different EF assessment levels. To conclude on pGMT efficacy, larger studies are needed, including further investigation of appropriate assessment levels and possible differences in effect related to treatment duration, developmental factors, and injury characteristics.

TRIAL REGISTRATION

ClinicalTrials.gov , NCT0321534211, 11 July 2017.

摘要

背景

儿童获得性脑损伤(pABI)后,执行功能(EF,即有目的、有目标的行为)受损会导致显著的残疾,因此需要有效的干预措施。目标管理训练(GMT)是一种元认知方案,已被证明对成年人的执行功能障碍有效。这项预先注册的、盲法、平行随机对照试验评估了儿童适应(pGMT)与心理教育对照(儿童大脑健康工作坊,pBHW)相比改善 EF 的疗效。

方法

年龄在 10 至 17 岁之间、有 pABI(例如,创伤性脑损伤、脑肿瘤)、发病后 1 年以上或已结束治疗、父母报告有 EF 问题的儿童符合条件。参与者按计算机算法随机分为小组式 pGMT(n=38)或 pBHW(n=38)。主动对照组经过精心设计,以保持非特异性因素不变。因此,两种治疗方法都包括在医院进行的 7 次治疗,共 3 周,随后是 4 周的参与者、父母和教师的电话咨询。父母报告的日常生活执行功能,通过问卷《行为评定量表的执行功能》(BRIEF;行为调节指数(BRI)和元认知指数(MI))进行评估,是干预后 6 个月的主要结果。次要结果包括神经心理学测试和一项复杂的自然任务(儿童烹饪任务)。

结果

73 名参与者(96%)完成了分配的干预措施,71 名(93%)参加了 6 个月的随访。结果显示,两种干预措施在父母报告的 EF 方面均无显著差异:对于 BRIEF,pGMT 的平均(SD)原始分数为 42.7(8.8),pBHW 为 38.3(9.3)。估计差值为-2.3(95%CI-5.1 至 0.6)。对于 BRIEF,GMT 的相应结果为 80.9(20.4),pBHW 为 75.5(19.3)。估计差值为-1.4(95%CI-8.5 至 5.8)。在基于表现的测试中,pGMT 与抑制和执行注意的改善有关,而 pBHW 与自然任务中的错误减少有关。

结论

在 pABI 中,与心理教育对照相比,元认知训练(pGMT)在 6 个月随访时并未显示出对父母报告的日常生活执行功能的额外效果。两种干预措施均耐受性良好,并在不同的执行功能评估水平上显示出明显的改善。要确定 pGMT 的疗效,还需要进行更大规模的研究,包括进一步调查适当的评估水平以及与治疗持续时间、发育因素和损伤特征相关的可能疗效差异。

试验注册

ClinicalTrials.gov,NCT0321534211,2017 年 7 月 11 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d03c/8561897/58463701e76c/12916_2021_2129_Fig1_HTML.jpg

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