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远程康复中的家长培训对自闭症谱系障碍(ASD)幼儿的作用:一项随机对照试验的研究方案。

Parent coaching via telerehabilitation for young children with autism spectrum disorder (ASD): study protocol for a randomised controlled trial.

机构信息

Child Development Unit, Department of Paediatrics, Khoo Teck Puat-National University Children's Medical Institute, National University Health System, 1E Kent Ridge Road, NUHS Tower Block Level 12, Singapore, 119228, Singapore.

Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.

出版信息

Trials. 2023 Jul 19;24(1):462. doi: 10.1186/s13063-023-07488-6.

Abstract

BACKGROUND

Early parent-implemented intervention enhances parent-child interaction and improves language skills in children with autism spectrum disorders (ASD). Parent coaching is often delivered as standard care for children with ASD, where parents are taught to apply strategies in their child's play activities and daily routines to achieve the prior stated goals. However, the ability to conduct parent coaching in physical in-clinic sessions is limited by resource constraints such as clinic space and therapist manpower. Furthermore, parents may experience difficulties with the generalisation of intervention strategies taught in the clinic to their natural home environments. In this study, telerehabilitation is evaluated as an alternative platform to deliver parent coaching for parent-implemented interventions to children with ASD in their homes.

METHODS

This parallel-group, randomised, controlled, non-inferiority trial aims to evaluate the effectiveness of parent coaching delivered through video conferencing (telerehabilitation) versus in-clinic (standard care) delivery. Children aged 15 to 48 months (n = 200) who meet the cut-off score for ASD on the Autism Diagnostic Observation Schedule-2 are eligible. Parent-child dyads are randomly assigned to receive parent coaching either through weekly telerehabilitation or standard care. The primary outcome is the child's development as measured by the subscale and composite scores of a standardised developmental assessment. Primary analysis will determine if the lower boundary of the 95% confidence interval for the mean difference in pre-post change between groups exceeds -5 (the non-inferiority margin). Secondary outcomes are the child's adaptive behaviour, parent-child interaction, parental stress, and family quality of life. Outcomes will be measured pre-intervention, midterm, and post-intervention. Secondary analysis will determine if there is any between-group difference for the pre-post change in scores at the 5% significance level using two-sample t-test or Mann-Whitney U test.

DISCUSSION

As a randomised controlled trial of a moderately large scale, this study will contribute to the limited existing literature on the effectiveness of parent coaching via telerehabilitation for early parent-implemented intervention for children with ASD. The results of this study will provide insights on whether telerehabilitation is comparable to conventional in-clinic parent coaching in enhancing parent-child interaction and improving language skills.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05792449. Registered (retrospectively) on 31 March 2023.

摘要

背景

早期家长实施的干预措施可增强亲子互动,并提高自闭症谱系障碍(ASD)儿童的语言技能。家长培训通常作为 ASD 儿童的标准护理提供,在此过程中,教父母将策略应用于孩子的游戏活动和日常生活中,以实现既定目标。然而,由于资源限制,如诊所空间和治疗师人力,在实体诊所中进行家长培训的能力有限。此外,父母可能难以将在诊所中教授的干预策略推广到其自然的家庭环境中。在这项研究中,远程康复被评估为一种替代平台,用于在家庭中为 ASD 儿童提供家长实施的干预措施的家长培训。

方法

这是一项平行组、随机、对照、非劣效性试验,旨在评估通过视频会议(远程康复)与实体诊所(标准护理)进行的家长培训的有效性。符合自闭症诊断观察量表-2 自闭症截止分数的 15 至 48 个月大的儿童(n=200)符合条件。家长-儿童对随机分配接受每周远程康复或标准护理的家长培训。主要结果是儿童的发育,由标准化发育评估的子量表和综合评分衡量。主要分析将确定组间预-后变化均值差异的 95%置信区间下限是否超过-5(非劣效性边界)。次要结果是儿童的适应行为、亲子互动、父母压力和家庭生活质量。结果将在干预前、中期和干预后进行测量。二次分析将确定在 5%显著水平下,使用两样本 t 检验或曼-惠特尼 U 检验,组间分数的预-后变化是否存在差异。

讨论

作为一项中等规模的随机对照试验,这项研究将有助于有限的现有文献,了解通过远程康复进行的家长培训对 ASD 儿童早期家长实施干预的有效性。这项研究的结果将提供关于远程康复是否可与传统实体诊所中的家长培训相媲美的见解,以增强亲子互动和提高语言技能。

试验注册

ClinicalTrials.gov NCT05792449。于 2023 年 3 月 31 日(追溯性)注册。

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