Department of Child and Adolescent Psychiatry, King's College London, Institute of Psychiatry, Psychology & Neuroscience, London, UK.
Department of Psychology, Aston University, School of Life and Health Sciences, Birmingham, UK.
BMJ Open. 2019 Jun 27;9(6):e029959. doi: 10.1136/bmjopen-2019-029959.
The majority of young autistic children display impairing emotional and behavioural difficulties that contribute to family stress. There is some evidence that behavioural parenting interventions are effective for reducing behavioural difficulties in autistic children, with less evidence assessing change in emotional difficulties. Previous trials have tended to use unblinded parent-report measures as primary outcomes and many do not employ an active control, limiting the conclusions that can be drawn.
The Autism Spectrum Treatment and Resilience study is a pilot randomised controlled trial (RCT) testing the specific effect of a 12-week group parenting intervention (Predictive Parenting) on primary and secondary outcomes, in comparison to an attention control condition consisting of psychoeducation parent groups. Following a feasibility study to test research procedures and the interventions, the pilot RCT participants include 60 parents of autistic children aged 4-8 years who are randomised to Predictive Parenting versus the attention control. Measures are administered at baseline and post intervention to assess group differences in child and parent outcomes, costs and service use and adverse events. The primary outcome is an objective measure of child behaviours that challenge during interactions with their parent and a researcher. The trial aims to provide data on recruitment, retention, completion of measures and acceptability of the intervention and research protocol, in addition to providing a preliminary indication of potential efficacy and establishing an effect size that could be used to power a larger-scale efficacy trial. We will also provide preliminary estimates of the cost-effectiveness of the interventions.
Ethical approval was granted from NHS Camden and Kings Cross Research Ethics Committee (ref: 16/LO/1769) along with NHS R&D approval from South London and Maudsley, Guy's and St Thomas', and Croydon Health Services NHS Trusts. The findings will be disseminated through publication in peer-reviewed journals and presentations at conferences.
ISRCTN91411078.
大多数患有自闭症的儿童都存在情绪和行为方面的障碍，这些障碍会给家庭带来压力。有证据表明，行为养育干预措施对减少自闭症儿童的行为障碍是有效的，但评估情绪障碍变化的证据较少。以前的试验往往使用未经盲法评估的父母报告测量作为主要结果，而且许多试验都没有采用积极对照，限制了可以得出的结论。
自闭症谱系治疗和韧性研究是一项试点随机对照试验（RCT），旨在测试为期 12 周的小组养育干预（预测养育）对主要和次要结果的具体影响，与包括心理教育家长小组的注意力对照条件进行比较。在进行可行性研究以测试研究程序和干预措施之后，试点 RCT 参与者包括 60 名年龄在 4-8 岁的自闭症儿童的父母，他们被随机分配到预测养育组或注意力对照组。在基线和干预后进行评估，以评估儿童和家长结果、成本和服务使用以及不良事件方面的组间差异。主要结果是对与父母和研究人员互动时具有挑战性的儿童行为进行客观测量。该试验旨在提供有关招募、保留、完成措施和干预措施及研究方案的可接受性的数据，此外还提供潜在疗效的初步迹象，并确定可用于更大规模疗效试验的效应大小。我们还将提供干预措施成本效益的初步估计。
NHS 卡姆登和国王十字研究伦理委员会（注册号：16/LO/1769）以及 NHS R&D 已批准南伦敦和莫德斯利、盖伊和圣托马斯以及克罗伊登健康服务 NHS 信托基金进行该研究。研究结果将通过在同行评议期刊上发表和在会议上发表来传播。
ISRCTN91411078。
