Division of Neuroscience and Experimental Psychology, University of Manchester, PACT-G Trial Office, Room 3.312, Jean McFarlane Building, Oxford Road, Manchester, M13 9PL, UK.
Royal Manchester Children's Hospital, Manchester University NHS Foundation Trust, Oxford Road, Manchester, M13 9WL, UK.
Trials. 2018 Sep 21;19(1):514. doi: 10.1186/s13063-018-2881-3.
Prior evidence shows that behaviours closely related to the intervention delivered for autism are amenable to change, but it is more difficult to generalise treatment effects beyond the intervention context. We test an early autism intervention designed to promote generalisation of therapy-acquired skills into home and school contexts to improve adaptive function and reduce symptoms. A detailed mechanism study will address the process of such generalisation. Objective 1 will be to test if the PACT-G intervention improves autism symptom outcome in the home and school context of the intervention as well as in the primary outcome research setting. Objective 2 will use the mechanism analysis to test for evidence of acquired skills from intervention generalizing across contexts and producing additive effects on primary outcome.
METHODS/DESIGN: This is a three-site, two-parallel-group, randomised controlled trial of the experimental treatment plus treatment as usual (TAU) versus TAU alone. Children aged 2-11 years (n = 244 (122 intervention/122 TAU; ~ 82/site) meeting criteria for core autism will be eligible. The experimental intervention builds on a clinic-based Pre-school Autism Communication Treatment model (PACT), delivered with the primary caregiver, combined with additional theory- and evidence-based strategies designed to enhance the generalisation of effects into naturalistic home and education contexts. The control intervention will be TAU.
autism symptom outcome, researcher-assessed using a standardised protocol.
autism symptoms, child interaction with parent or teacher, language and reported functional outcomes in home and school settings. Outcomes measured at baseline and 12-month endpoint in all settings with interim interaction measurements (7 months) to test treatment effect mechanisms. Primary analysis will estimate between-group difference in primary outcome using analysis of covariance with test of homogeneity of effect across age group. Mechanism analysis will use regression models to test for mediation on primary outcome by parent-child and teaching staff-child social interaction.
This is an efficacy and mechanism trial of generalising evidence-based autism treatment into home and school settings. It will provide data on whether extending treatment across naturalistic contexts enhances overall effect and data on the mechanism in autism development of the generalisation of acquired developmental skills across contexts.
ISRCTN, ID: 25378536 . Prospectively registered on 9 March 2016.
先前的证据表明，与自闭症干预措施密切相关的行为是可以改变的，但将治疗效果推广到干预背景之外更为困难。我们测试了一种早期自闭症干预措施，旨在促进治疗中获得的技能在家庭和学校环境中的推广，以提高适应性功能并减少症状。一项详细的机制研究将解决这种推广的过程。目标 1 将测试 PACT-G 干预是否可以改善干预家庭和学校环境以及主要研究设置中的自闭症症状结果。目标 2 将使用机制分析来测试干预从跨环境中获得的技能的证据，并对主要结果产生附加影响。
方法/设计：这是一项三地点、两平行组、随机对照试验，对实验组治疗加治疗常规（TAU）与 TAU 单独进行比较。符合核心自闭症标准的 2-11 岁儿童（n=244（122 例实验组/122 例 TAU；每个地点约 82 例）符合条件。实验组治疗以诊所为基础的学前自闭症沟通治疗模式（PACT）为基础，由主要照顾者实施，结合额外的基于理论和循证的策略，旨在增强治疗效果在自然家庭和教育环境中的推广。对照组治疗将是 TAU。
自闭症症状结果，研究人员使用标准化方案进行评估。
自闭症症状、儿童与父母或教师的互动、语言和家庭及学校环境中的报告功能结果。所有环境中的结果均在基线和 12 个月终点进行测量，并在 7 个月时进行中间互动测量，以测试治疗效果机制。主要分析将使用协方差分析估计主要结果的组间差异，并测试年龄组之间效果的同质性检验。机制分析将使用回归模型来测试主要结果是否通过亲子互动和教学人员与儿童互动的中介作用来测试。
这是一项将循证自闭症治疗推广到家庭和学校环境中的疗效和机制试验。它将提供数据，说明在自然环境中扩展治疗是否可以提高整体效果，以及关于自闭症发展中获得的发展技能在跨环境中推广的机制数据。
ISRCTN，ID：25378536。于 2016 年 3 月 9 日前瞻性注册。
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