Efficacy of a stepped-care approach for school-age children with mild to moderate ADHD (ESCAschool-moderate): an adaptive intervention study including a randomized controlled trial.

IF 4.9 3区 医学 Q1 PEDIATRICS
Manfred Döpfner, Christina Dose, Christopher Hautmann, Martin Hellmich, Lea Teresa Kohl, Anne-Katrin Treier, Elena von Wirth, Katja Becker, Daniel Brandeis, Ute Dürrwächter, Julia Geissler, Sarah Hohmann, Martin Holtmann, Michael Huss, Thomas Jans, Anna Kaiser, Johanna Ketter, Tanja Legenbauer, Sabina Millenet, Luise Poustka, Tobias J Renner, Jasmin Wenning, Tobias Banaschewski
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引用次数: 0

Abstract

Background: This German multicenter study aimed to analyze the efficacy of telephone-assisted self-help (TASH) and changes during subsequent adaptive treatment in children with mild-to-moderate ADHD.

Methods: Participants were children (6;0-11;11 years) with mild-to-moderate ADHD. Study Step 1 comprised a randomized waitlist-controlled trial on the efficacy of three-month, parent-directed TASH. Depending on their response to TASH, in Step 2, children were assigned to booster TASH (full response), behavior therapy (partial response), or pharmacotherapy plus behavior therapy or counseling (non-response) for six months. The primary outcome was the change in blinded-clinician-rated ADHD symptoms; for subsequent changes (Step 2), we considered semi-blinded ratings. The primary analyses were by intention-to-treat.

Results: Of the 163 included children (77.9% boys), 80 were randomized to TASH and 83 to the waitlist control group. Following TASH, 12 children (8.8%) were classified as full responders, 40 (29.2%) as partial responders, and 85 (62.0%) as non-responders. An analysis of covariance did not yield an effect of TASH on the primary outcome (mean between-group difference = 0.00 ± 0.07, 95% CI[- 0.14, 0.13]; p = 0.95; d = -0.01, 95% CI[- 0.37, 0.34]). During Step 2, full responders demonstrated a stable symptom level (piecewise mixed-effects model for repeated measures; d = - 0.07, 95% CI[- 0.61, 0.47], p = 0.80), partial responders a small increase in ADHD symptoms (d = 0.29, 95% CI[0.00, 0.59], p = 0.05), and non-responders a large decrease (d = - 1.00, 95% CI[- 1.27, - 0.73], p < 0.001).

Conclusions: TASH is not effective in reducing blinded-clinician-rated ADHD symptoms in children with mild-to-moderate ADHD. Based on the changes within the response groups during Step 2, hypotheses are generated for adaptive treatment after TASH. Trial registration German Clinical Trials Register (DRKS): DRKS0000897; URL: https://drks.de/search/de/trial/DRKS00008973/details ; registered on December 18th 2015.

阶梯式护理方法对轻度至中度ADHD学龄儿童的疗效:一项包括随机对照试验的适应性干预研究
背景:德国的一项多中心研究旨在分析电话辅助自助(TASH)的疗效,以及在随后的适应性治疗中对轻度至中度ADHD儿童的影响。方法:参与者是患有轻中度ADHD的儿童(6岁;0-11岁;11岁)。研究步骤1包括一项为期三个月、由家长指导的TASH疗效的随机候补对照试验。根据他们对TASH的反应,在步骤2中,儿童被分配到加强TASH(完全反应),行为治疗(部分反应),或药物治疗加行为治疗或咨询(无反应)六个月。主要结果是临床盲评ADHD症状的改变;对于随后的改变(步骤2),我们考虑了半盲评分。主要分析是意向治疗。结果:在纳入的163名儿童中(77.9%为男孩),80名被随机分配到TASH组,83名被随机分配到等待名单对照组。在TASH之后,12名儿童(8.8%)被分类为完全应答者,40名(29.2%)被分类为部分应答者,85名(62.0%)被分类为无应答者。协方差分析未发现TASH对主要结局有影响(组间平均差异= 0.00±0.07,95% CI[- 0.14, 0.13]; p = 0.95; d = -0.01, 95% CI[- 0.37, 0.34])。在步骤2中,完全应答者表现出稳定的症状水平(重复测量的分段混合效应模型;d = - 0.07, 95% CI[- 0.61, 0.47], p = 0.80),部分应答者的ADHD症状小幅增加(d = 0.29, 95% CI[0.00, 0.59], p = 0.05),无应答者的ADHD症状大幅减少(d = - 1.00, 95% CI[- 1.27, - 0.73], p)。结论:TASH对减轻临床盲评的轻中度ADHD儿童的ADHD症状无效。根据第2步反应组内的变化,对TASH后的适应性治疗产生假设。德国临床试验注册(DRKS): DRKS0000897;网址:https://drks.de/search/de/trial/DRKS00008973/details;于2015年12月18日注册。
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来源期刊
Child and Adolescent Psychiatry and Mental Health
Child and Adolescent Psychiatry and Mental Health PEDIATRICSPSYCHIATRY-PSYCHIATRY
CiteScore
7.00
自引率
3.60%
发文量
84
审稿时长
16 weeks
期刊介绍: Child and Adolescent Psychiatry and Mental Health, the official journal of the International Association for Child and Adolescent Psychiatry and Allied Professions, is an open access, online journal that provides an international platform for rapid and comprehensive scientific communication on child and adolescent mental health across different cultural backgrounds. CAPMH serves as a scientifically rigorous and broadly open forum for both interdisciplinary and cross-cultural exchange of research information, involving psychiatrists, paediatricians, psychologists, neuroscientists, and allied disciplines. The journal focusses on improving the knowledge base for the diagnosis, prognosis and treatment of mental health conditions in children and adolescents, and aims to integrate basic science, clinical research and the practical implementation of research findings. In addition, aspects which are still underrepresented in the traditional journals such as neurobiology and neuropsychology of psychiatric disorders in childhood and adolescence are considered.
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