支持自闭症或ADHD患儿发展强注意力、调节和思维技能(START)项目的可行性随机对照试验方案。

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Alexandra Hendry, Maryna Nosyk, Victoria Hulks, Jemma Hudson, Lynda Constable, Tony Charman, Sandra Mathers, Sinead Rhodes, Gaia Scerif
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引用次数: 0

摘要

背景:自闭症和多动症是可遗传的,同时发生,并与执行功能困难(使我们能够设定目标并朝着目标努力的认知和自我调节技能)有关。执行功能困难及其在认知、健康和社会领域的负面影响,延伸到有一级亲属患有自闭症或多动症的个体,即使他们自己没有达到临床诊断的门槛。支持自闭症儿童的执行功能发展,或自闭症或多动症的一级亲属,解决社区早期支持的优先事项,以帮助实现最佳的心理健康,教育和生活结果。方法:本研究将评估一项名为“支持有自闭症或ADHD的幼儿发展较强的注意力、调节和思维能力”的父母-幼儿项目的随机对照试验(RCT)的可行性和可接受性。START是一个神经多样性确认项目,通过广泛的患者和公众参与共同完善。60对来自牛津或南安普顿(英国)的父母和孩子将被一名不参与招募、交付或结果数据收集的研究人员随机使用密封信封,以1:1的比例接受START或常规做法。儿童(20个月大)将在干预后(主动干预结束后2周内,当儿童年龄为27-31个月)使用父母填写的问卷进行评估,并在基线和随访(36个月大)时使用父母问卷和一系列执行功能测量,这些测量由对分配不知情的研究人员管理。START将在社区环境中以小组形式提供给30对亲子二人组。讨论:我们将评估招募符合条件的参与者参与研究的可行性、实施保真度测量的可靠性和达到的实施保真度、拟议结果和机制测量的适当性、项目随机对照试验的可接受性、家长对项目的依从性、项目交付的后勤以及START的可接受性,使用参与和满意度的混合方法测量。研究结果将为START的最终随机对照试验的设计和实施提供信息,并对社区环境中复杂的早期干预措施的提供和评估产生更广泛的见解。试验注册:ISRCTN注册表ISRCTN99820028 https://doi.org/10.1186/ISRCTN99820028。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Protocol for a feasibility randomized control trial of the Supporting Toddlers with a connection to autism or ADHD to develop Strong Attention, Regulation, and Thinking skills (START) programme.

Background: Autism and ADHD are heritable, co-occurrent, and associated with difficulties with executive functioning (cognitive and self-regulation skills which enable us to set and work toward goals). Executive function difficulties, and their negative impacts across cognitive, health and social domains, extend to individuals with first-degree relatives who are autistic or have ADHD, even if they do not meet thresholds for a clinical diagnosis themselves. Supporting executive function development in children with elevated autism traits, or a first-degree relative with autism or ADHD, addresses community priorities for early support to help achieve the best mental health, education and life outcomes.

Methods: This study will evaluate the feasibility and acceptability of a randomized controlled trial (RCT) of a parent-toddler programme entitled "Supporting Toddlers with a connection to autism or ADHD to develop strong Attention, Regulation and Thinking skills" (START). START is a neurodiversity-affirming programme, co-refined through extensive Patient and Public Involvement. Sixty parent-child dyads, in Oxford or Southampton (UK), will be randomized using Sealed Envelope by a researcher not involved in recruitment, delivery or outcome data collection to receive START or usual practice, on a 1:1 ratio. Children (20 months old) will be assessed using questionnaires completed by the parent (not blind to allocation) post-intervention (within 2 weeks of the end of the active intervention wave, when children are aged 27-31 months), and using parent questionnaires and a battery of executive function measures administered by researchers blind to allocation at baseline and follow-up (36 months old). START will be delivered in small groups to 30 parent-child dyads, in community settings.

Discussion: We will assess the feasibility of recruiting eligible participants to the study, the reliability of measures of implementation fidelity and degree of implementation fidelity achieved, the appropriateness of proposed outcome and mechanism measures, the acceptability of an RCT of the programme, parental adherence to the programme, logistics of programme delivery, and the acceptability of START, using mixed-method measures of engagement and satisfaction. Results will inform the design and implementation of a definitive RCT of START, and yield broader insights into the delivery and evaluation of complex early-years interventions in community settings.

Trial registration: ISRCTN registry ISRCTN99820028 https://doi.org/10.1186/ISRCTN99820028 .

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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
期刊介绍: Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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