Department of Child and Adolescent Mental Health Services Southern Jutland, Region of Southern Denmark, Kresten Phillipsens Vej 15, Aabenraa, Denmark.
Department of Clinical Research, University of Southern Denmark, Winsløwsparken 19, Odense, Denmark.
Eur Child Adolesc Psychiatry. 2018 Dec;27(12):1563-1574. doi: 10.1007/s00787-018-1151-y. Epub 2018 Apr 11.
Multicenter randomized clinical superiority single-blind trial investigated the effect of a computer training program targeting multiple cognitive functions. Seventy children with ADHD, aged 6-13, were randomized to intervention or control group. The intervention group used ACTIVATE™ for 8 weeks and both groups received treatment as usual and were assessed in regard to cognitive functions, symptoms, behavioral and functional outcome measures after 8, 12 and 24 weeks. There was no significant effect on the primary outcome, sustained attention (β = - 0.047; CI - 0.247 to 0.153) or the secondary outcomes [parent-rated ADHD-RS, β = - 0.037; CI (- 0.224 to 0.150); teacher-rated-ADHD-RS, β = 0.093; CI (- 0.107 to 0.294); parent-rated-BRIEF, β = - 0.119; CI (- 0.307 to 0.069); and teacher-rated-BRIEF, β = 0.136; CI (- 0.048 to 0.322)]. This multicenter randomized clinical trial found no significant beneficial effects of cognitive training using the computer program ACTIVATE on the primary or secondary outcome measures in children with ADHD. Nevertheless, our study was likely underpowered to detect small to moderate changes.Trial registration ClinicalTrials.gov: NCT01752530, date of registration: December 10, 2012.
多中心随机临床优效性单盲试验研究了一种针对多种认知功能的计算机训练程序的效果。70 名年龄在 6-13 岁的 ADHD 儿童被随机分为干预组或对照组。干预组使用 ACTIVATE™进行 8 周的治疗,两组均接受常规治疗,并在 8、12 和 24 周后评估认知功能、症状、行为和功能结局。主要结局(持续注意力)没有显著效果(β= - 0.047;CI - 0.247 至 0.153),次要结局也没有显著效果[父母评定 ADHD-RS,β= - 0.037;CI(- 0.224 至 0.150);教师评定 ADHD-RS,β= 0.093;CI(- 0.107 至 0.294);父母评定 BRIEF,β= - 0.119;CI(- 0.307 至 0.069);教师评定 BRIEF,β= 0.136;CI(- 0.048 至 0.322)]。这项多中心随机临床试验发现,使用计算机程序 ACTIVATE 对 ADHD 儿童进行认知训练,对主要或次要结局没有显著的有益效果。然而,我们的研究可能没有足够的效力来检测到较小或中等的变化。试验注册ClinicalTrials.gov:NCT01752530,注册日期:2012 年 12 月 10 日。