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对巴勒斯坦自闭症儿童及其父母的远程辅导干预

2026年8月20日 更新者:Mohammad Salahat、Arab American University (Palestine)

调查巴勒斯坦自闭症儿童及其父母家长远程辅导干预的潜在功效、可行性和可接受性:混合方法试点随机对照试验

在巴勒斯坦,由于缺乏专业专业人员和中心,以及文化、政治、地理和经济障碍,患有自闭症谱系障碍的儿童及其父母在接受所需的早期干预和康复服务方面面临困难。 父母在家中抚养患有自闭症的孩子也面临困难,因为他们缺乏对这种疾病的了解以及可以用来帮助这些孩子的最佳干预措施。

家长远程辅导干预,或所谓的(通过技术进行的远程辅导)可以帮助患有自闭症的父母及其孩子。 然而,目前尚无研究探讨在巴勒斯坦对父母及其子女使用这种干预措施的可能性,以及是否可以对父母和子女产生积极的结果。

这项试验的目的是了解家长远程辅导干预是否可行并能为巴勒斯坦自闭症儿童的家长所接受。 它还将了解这种干预措施是否有可能提高儿童的技能并提高父母的自我能力和生活质量。 它旨在回答的主要问题是:

  • 在多大程度上和以什么方式为巴勒斯坦自闭症儿童的父母提供远程指导干预是可能的?
  • 家长如何看待远程辅导干预的适宜性、益处、促进因素和障碍?
  • 对父母进行远程辅导干预是否有可能增加孩子对父母认为重要的日常活动的参与度?
  • 远程辅导干预是否有可能提高父母的自我能力和家庭生活质量? 研究人员将家长远程辅导干预与旨在为家长提供有关自闭症一般信息的网络资源进行比较,看看家长远程辅导干预是否比网站上提供的免费自闭症资源更能帮助自闭症儿童及其父母。

参与者将:

  • 采取远程辅导干预(八周内八次会议,每次会议持续一小时)或使用网站上提供的有关自闭症的信息。
  • 在一周内与孩子一起应用计划的策略,并使用视频或填写表格来记录他们的工作,以便在每次课程开始时进行审查。

研究概览

详细说明

将采用有目的抽样技术来招募患有自闭症谱系障碍的儿童及其居住在西岸地区的父母/照顾者。 将采用两种招募策略来邀请来自西岸各地区的参与者。 第一个将涉及与第三方超级英雄自闭症基金会联系,根据提供的纳入和排除标准向潜在的合格参与者分发邀请包。 选择该基金会是因为它可以访问西岸自闭症儿童的大量数据集。 第二个策略将涉及在社交媒体和患者组织网站上发布传单广告。 希望参与的人将被要求使用提供的联系信息(电子邮件或 WhatsApp)将签名的回复单发送给试验作者。 之后,我们将通过电话联系他们以筛选他们的资格。 符合资格标准的家长将被告知,将与他们每个人进行初次会面,以进一步解释试验的目的,检查他们接受随机分组的意愿,回答他们可能有的任何问题,确认他们同意参与,商定将在随机分组之前进行的第一次评估会议的日期和时间,并讨论后续远程辅导会议的时间表。

样本量:试点随机试验通常不需要样本功效计算。 然而,根据经验,试点随机对照试验至少需要 30 名参与者。 为了解决 10% 的潜在流失率,将招募 40 名亲子二人组(每组 20 人)。

随机化:该研究将采用分层分组随机化方法,以 1:1 的比例将家长分配到远程辅导干预组或候补对照组。 一旦对同意参与的合格参与者完成基线评估,将向每位家长分配一个筛查号码,并记录孩子的自闭症症状评分。 使用自闭症治疗评估清单,该分数将被分类为 <60 或 ≥60。 然后,为每个参与者分配的筛查编号和孩子的自闭症严重程度评分将发送给非研究成员(职业治疗部门的讲师),他将使用计算机根据预定的四块大小进行分配和随机化过程- 生成随机序列。 将根据自闭症严重程度分类为 <60 或 ≥60 进行分层。 选择这种方法是为了确保每组参与者的平均分配,并尽量减少儿童自闭症严重程度的影响。 负责招募参与者的试验作者将无权访问隐藏的随机分配序列。 然而,由于干预的性质,对分配给参与者的治疗进行盲法是不可行的。 随机参与者的所有数据都将记录在病例报告表 (CRF) 中。 参与者将通过电话联系获悉随机结果。

定量数据分析:

社会科学统计软件包 (SPSS) 第 26 版将用于进行所有统计分析。

描述性统计将用于分析以下内容:

  • 可行性标准(1,3,4,6):资格、保留、提供者干预的忠诚度和不良事件(如果发生)。
  • 将使用百分比、平均值和标准差来分析参与者的人口统计数据。
  • 加拿大职业绩效衡量标准 (COPM) 中家庭特定目标的共性。

推论统计(家长远程辅导干预的潜在功效):

t 检验将用于检查测试前和测试后(组间和组内)的均值变化。

定性分析(可接受性、好处、促进因素和障碍):

将使用六个迭代步骤对录制的访谈进行分析:(1)熟悉,(2)初始编码,(3)主题识别,(4)主题审查,(5)主题定义和命名,以及(6)报告制作。 试验作者和同事将审查并创建初始代码,重新访问完整的转录,并使用代码搜索主题。 他们将多次会面,以确保主题名称准确描述报告。

研究类型

介入性

注册 (实际的)

26

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

纳入标准:

  • 父母是主要的照顾者,在干预期间大部分时间都与孩子在一起
  • 父母年满 18 岁并且能够提供知情同意书
  • 家长可以使用手机、平板电脑或装有 Zoom 软件和稳定互联网连接的电脑等移动设备
  • 这些孩子的年龄在 3 至 6 岁之间,并且已被精神科医生或儿科医生确诊为自闭症谱系障碍 (ASD)。
  • 患有自闭症谱系障碍和其他合并症的儿童也有资格参加。

排除标准:

  • 患有 ASD 的青少年和老年人。

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:OPC Telecoaching
Participants allocated to this arm received an eight-week individualized Occupational Performance Coaching (OPC) intervention delivered remotely through Zoom and supported by the Sanad Alhayaa digital platform.
Occupational Performance Coaching (OPC) is a collaborative, occupation-focused coaching approach that supports parents to identify meaningful participation goals, analyze occupational performance challenges, generate possible solutions, implement strategies within everyday routines, and review progress. In this study, OPC was delivered individually through eight weekly 40-60 minute Zoom sessions. Sanad Alhayaa supported appointment booking, electronic questionnaires, secure individualized resources, and intervention documentation.
其他:Waitlist Control: General Digital Resources
During the eight-week randomized comparison period, participants allocated to this arm had access to general autism-related resources through the Sanad Alhayaa digital platform but did not receive individualized OPC. After completing the post-intervention assessment, they were offered the OPC telecoaching intervention.
General Arabic-language information and videos addressing autism, sensory needs, social interaction, and activities of daily living were made available through the Sanad Alhayaa resource library. This resource access did not include individualized coaching, individualized resource uploads, private clinical messaging, or coaching-session booking.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Percentage of Recruitment Target Achieved
大体时间:During the recruitment period
Recruitment was assessed as the percentage of the prespecified recruitment target achieved during the planned recruitment period. The prespecified progression criterion was recruitment of 30 parent-child dyads within four weeks.
During the recruitment period
Percentage of Participants Successfully Completing Required Digital Platform Procedures
大体时间:From enrollment through post-intervention assessment (approximately 8 weeks)
Digital platform feasibility was assessed as the percentage of participants who successfully completed the required Sanad Alhayaa platform procedures, including account creation and child-profile registration. The prespecified progression criterion was successful completion of the required platform procedures by at least 80% of participants.
From enrollment through post-intervention assessment (approximately 8 weeks)
Percentage of Participants Successfully Randomized According to the Prespecified Procedure
大体时间:Immediately after baseline assessment
Randomization feasibility was assessed as the percentage of randomized participants allocated according to the prespecified randomization procedure without allocation errors or major protocol deviations. The prespecified progression criterion was successful allocation of all randomized participants without errors or major deviations.
Immediately after baseline assessment
Percentage of Participants Completing Required Online Study Questionnaires
大体时间:At baseline and post-intervention (approximately 8 weeks)
Questionnaire completion was assessed as the percentage of participants who completed the required online study questionnaires at baseline and post-intervention. The prespecified progression criterion was questionnaire completion by at least 80% of participants at each assessment point.
At baseline and post-intervention (approximately 8 weeks)
Percentage of Randomized Participants Completing Post-Intervention Assessment
大体时间:From randomization through post-intervention assessment (approximately 8 weeks)
Participant retention was assessed as the percentage of randomized participants who completed the post-intervention assessment. The prespecified progression criterion was retention of at least 80% of randomized participants.
From randomization through post-intervention assessment (approximately 8 weeks)
Percentage of Intervention Participants Attending at Least 7 of 8 OPC Sessions
大体时间:During the 8-week OPC intervention period
Intervention attendance was assessed as the percentage of intervention participants who attended at least seven of the eight planned OPC telecoaching sessions. The prespecified progression criterion was attendance at a minimum of seven of eight sessions.
During the 8-week OPC intervention period
OPC Fidelity Measure: Percentage of Prescribed Components Demonstrated
大体时间:During the 8-week OPC intervention period
Intervention fidelity was assessed using the OPC Fidelity Measure in independently audited OPC sessions. Fidelity was calculated as the percentage of prescribed OPC components demonstrated during each audited session. The prespecified progression criterion was fidelity of at least 80%.
During the 8-week OPC intervention period
Number of Serious Adverse Events Attributable to Study Participation
大体时间:From enrollment through post-intervention assessment (approximately 8 weeks)
Safety was assessed as the number of serious adverse events considered attributable to study participation. The prespecified progression criterion was no serious adverse events attributable to study participation.
From enrollment through post-intervention assessment (approximately 8 weeks)
Mean Saudi Telehealth Acceptance Scale (STAS) Score
大体时间:Baseline and post-intervention (8 weeks)
The STAS is a 24-item Arabic-language measure of telehealth acceptance covering Performance Expectancy, Effort Expectancy, Social Influence, Facilitating Conditions, and Behavioral Intention. Items are rated from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating greater acceptance of telehealth. Domain and overall scores were assessed at baseline and post-intervention.
Baseline and post-intervention (8 weeks)

次要结果测量

结果测量
措施说明
大体时间
Canadian Occupational Performance Measure
大体时间:Baseline and post-intervention (8 weeks)
The COPM is an individualized, occupation-focused measure in which parents identify and prioritize occupational performance goals for their child. For prioritized goals, parents rate perceived performance and satisfaction with performance separately on 10-point scales ranging from 1 to 10, with higher scores indicating better perceived performance or greater satisfaction. Mean Performance and Satisfaction scores were calculated separately and change was assessed from baseline to post-intervention. The COPM was administered only to participants allocated to OPC because it formed part of individualized goal identification and intervention planning.
Baseline and post-intervention (8 weeks)
Autism Treatment Evaluation Checklist (ATEC)
大体时间:Baseline and post-intervention (8 weeks)
The ATEC is a 77-item parent-report measure comprising four domains: Speech/Language/Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical/Behavior. Domain scores and the total score were calculated separately. Total scores range from 0 to 179, with lower scores indicating fewer autism-related difficulties. Change in domain and total scores was assessed from baseline to post-intervention.
Baseline and post-intervention (8 weeks)
Childhood Autism Rating Scale, Second Edition (CARS-2)
大体时间:Baseline and post-intervention (8 weeks)
The CARS-2 is a clinician-rated measure of autism-related characteristics comprising 15 items rated from 1 to 4. Item ratings are summed to produce a total score ranging from 15 to 60, with higher scores indicating greater severity of autism-related characteristics. Change in total score was assessed from baseline to post-intervention.
Baseline and post-intervention (8 weeks)
Parental Competence Scale for Children with Autism Spectrum Disorder
大体时间:Baseline and post-intervention (8 weeks)
The PCS-ASD is a 29-item Arabic-language measure of parental competence. Items are rated on a 5-point Likert scale, with negatively worded items reverse scored. Total scores range from 29 to 145, with higher scores indicating greater perceived parental competence. Change in total score was assessed from baseline to post-intervention.
Baseline and post-intervention (8 weeks)
World Health Organization Quality of Life, Brief Version (WHOQOL-BREF)
大体时间:Baseline and post-intervention (8 weeks)
The WHOQOL-BREF is a 26-item measure of quality of life covering four domains: Physical Health, Psychological, Social Relationships, and Environment, together with two global items. Items are rated on 5-point response scales. Domain scores are calculated according to WHO scoring guidance, with higher scores indicating better quality of life. Change in domain scores was assessed from baseline to post-intervention.
Baseline and post-intervention (8 weeks)
Arabic Quality of Life in Autism (A-QoLA)
大体时间:Baseline and post-intervention (8 weeks)
The A-QoLA is an autism-specific parent-reported quality-of-life measure comprising two separately scored parts. Part A assesses parents' general quality of life, with higher scores indicating better quality of life. Part B assesses the perceived impact of the child's autism-related difficulties on the parent, with higher scores indicating that parents are less affected by those difficulties. Part A and Part B were scored and interpreted separately. Change in each part was assessed from baseline to post-intervention.
Baseline and post-intervention (8 weeks)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Mohammad Salahat, PhD、Arab American University (Palestine)

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年2月15日

初级完成 (实际的)

2025年6月21日

研究完成 (实际的)

2025年6月21日

研究注册日期

首次提交

2024年5月18日

首先提交符合 QC 标准的

2024年5月23日

首次发布 (实际的)

2024年5月24日

研究记录更新

最后更新发布 (实际的)

2026年8月24日

上次提交的符合 QC 标准的更新

2026年8月20日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be made publicly available because the study involved a small sample of parent-child dyads from a defined population and the consent process did not include public sharing of individual-level participant data. De-identified aggregate study findings will be reported in scientific publications.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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