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自闭症、语言与沟通能力培养评估研究(PALACES):一项试点随机对照试验的方案

Parenting for Autism, Language, And Communication Evaluation Study (PALACES): protocol for a pilot randomised controlled trial.

作者信息

Williams Margiad Elen, Hastings Richard, Charles Joanna Mary, Evans Sue, Hutchings Judy

机构信息

Centre for Evidence Based Early Intervention, Bangor University, Wales, UK.

Centre for Educational Development, Appraisal and Research, University of Warwick, Warwick, UK.

出版信息

BMJ Open. 2017 Feb 16;7(2):e014524. doi: 10.1136/bmjopen-2016-014524.

Abstract

INTRODUCTION

Children with autistic spectrum disorder (ASD) often have associated behavioural difficulties that can present a challenge for parents and parenting. There are several effective social learning theory-based parenting programmes for dealing with behavioural difficulties, including the Incredible Years (IY) parent programmes. However, these programmes typically do not specifically target parents of children with ASD. Recently, a new addition to the IY suite of programmes known as the IY Autistic Spectrum and Language Delays (IY-ASLD) parent programme was developed. The main aims of the present study are to examine the feasibility of delivering this programme within child health services and to provide initial evidence for effectiveness and economic costs.

METHODS AND ANALYSIS

The Parenting for Autism, Language, And Communication Evaluation Study (PALACES) trial is a pragmatic, multicentre, pilot randomised controlled trial comparing the IY-ASLD programme with a wait-list control condition. 72 parents of children with ASD (aged 3-8 years) will be randomly allocated to either the intervention or control condition. Data will be collected prior to randomisation and 6 months postrandomisation for all families. Families in the intervention condition only will also be followed up at 12 and 18 months postrandomisation. This study will provide initial evidence of effectiveness for the newly developed IY-ASLD parenting programme. It will also add to the limited economic evidence for an intervention targeting parents of children with ASD and provide longer term data, an important component for evaluations of parenting programmes.

ETHICS AND DISSEMINATION

Approval for the study was granted by the Research Ethics Committee at the School of Psychology, Bangor University (reference number: 2016-15768) and the North Wales Research Ethics Committee, UK (reference number: 16/WA/0224). The findings will be disseminated through research conferences and peer-reviewed journals.

TRIAL REGISTRATION NUMBER

ISRCTN57070414; Pre-results.

摘要

引言

患有自闭症谱系障碍(ASD)的儿童常常伴有行为问题,这给家长及其养育方式带来了挑战。有几种基于社会学习理论的有效养育方案可用于应对行为问题,其中包括“神奇岁月”(IY)家长方案。然而,这些方案通常并未专门针对ASD儿童的家长。最近,IY方案系列中新增了一个名为“自闭症谱系与语言迟缓的神奇岁月”(IY - ASLD)的家长方案。本研究的主要目的是检验在儿童健康服务中提供该方案的可行性,并为其有效性和经济成本提供初步证据。

方法与分析

自闭症、语言及沟通养育评估研究(PALACES)试验是一项实用的多中心试点随机对照试验,将IY - ASLD方案与等待名单对照条件进行比较。72名ASD儿童(年龄在3至8岁)的家长将被随机分配至干预组或对照组。所有家庭在随机分组前及随机分组后6个月收集数据。仅干预组的家庭还将在随机分组后12个月和18个月进行随访。本研究将为新开发的IY - ASLD养育方案的有效性提供初步证据。它还将补充针对ASD儿童家长干预措施的有限经济证据,并提供长期数据,这是养育方案评估的一个重要组成部分。

伦理与传播

本研究已获得班戈大学心理学院研究伦理委员会(参考编号:2016 - 15768)及英国北威尔士研究伦理委员会(参考编号:16/WA/0224)的批准。研究结果将通过研究会议和同行评审期刊进行传播。

试验注册号

ISRCTN57070414;预结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/99d9/5318566/4eeefad1c8f4/bmjopen2016014524f01.jpg

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