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Acceptance and Commitment Therapy for Parenting Children With Cerebral Palsy

2026年9月6日 更新者:Kenneth N. K. Fong、The Hong Kong Polytechnic University

Effects of Acceptance and Commitment Therapy on Psychological Outcomes and Quality of Life of Parents of Children With Cerebral Palsy: A Randomized Controlled Trial.

The goal of this randomized controlled trial is to evaluate whether a group-based acceptance and commitment therapy (ACT) can improve the psychological outcomes and quality of life (QOL) of children with cerebral palsy. The main questions it aims to answer are:

  • Does a group-based ACT improve the psychological flexibility of the participants?
  • Does a group-based ACT improve the psychological distress, including depression, anxiety, and stress, of the participants?
  • Does a group-based ACT improve the QOL of the participants?

Researchers will compare a group-based ACT to usual/standard care to determine whether ACT improves participants' psychological outcomes and QOL.

Participants will:

  • Receive eight weekly, face-to-face, group-based ACT sessions, each lasting approximately 90 minutes.
  • Receive home-based practices following each session.
  • Receive a weekly phone call assessment to address any study-related concerns and provide reminders for the next appointment or assessment day.
  • Complete the questionnaires at three times: baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).

研究概览

研究类型

介入性

注册 (估计的)

76

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。

学习联系方式

研究联系人备份

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

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Parents of children under 18 years with any type and severity of cerebral palsy
  • Able to communicate in Amharic, and
  • Able to provide written consent for participation

Exclusion Criteria:

  • Participants who have known psychological or psychiatric problems, and
  • Participants who are currently participating or have participated in another similar or related study within six months

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:支持治疗
  • 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:ACT intervention

Participants in the intervention group will receive an ACT that consists of eight sessions. Th introductions include an introduction, cognitive defusion, acceptance, being present, values, committed action, and noticing self/self-as context, and a summary session. An ACT-trained researcher will deliver weekly, face-to-face, group-based sessions, each lasting approximately 90 minutes, though durations may vary to accommodate group variations. Each group will consist of five to seven participants.

The interventions will be delivered via various strategies, including psychoeducation, discussion, mindfulness exercises, and metaphors supplemented with with home practices.

A research assistant will conduct a weekly phone call assessment to address any study-related concerns and provide reminders for the next appointment or assessment day.

其他:Usual/standard treatment
Participants in the control group will receive the usual or standard care provided by the respective center. To enhance participant retention in the study, a weekly phone call will be conducted by a research assistant, during which participants will be asked whether they have any concerns about the study and reminded of the next appointment or assessment day.

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
Level of psychological flexibility
大体时间:Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
The psychological flexibility will be assessed using the 7-item Acceptance and Action Questionnaire-II (AAQ-II). Each item in the AAQ-II is scored on a scale of seven from 1(never true) to 7(always true). The total score is obtained by summing the scores of all items, and the higher the total score indicates greater psychological inflexibility.
Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).
Level of psychological distress
大体时间:Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).

The psychological distress outcomes including, anxiety, depression, and stress will be assessed using the self-report 21-item anxiety, depression, and stress scale (DASS-21).

Each of the subscales comprises 7 items and is scored on a four-point Likert scale ranging from 0(didn't apply at all to me) to 3(applied to me very much or most of the time), and the score is calculated by summing up the items in each subscale, and the final core is obtained by multiplying the core by two to make it comparable with the full scale (DASS-42). The higher the core indicates high distress symptoms.

Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).

次要结果测量

结果测量
措施说明
大体时间
Level of quality of life
大体时间:Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).

The quality of life will be evaluated by using the World Health Organization Quality of Life-BREF (WHOQOL-BREF).

It comprises four domains: physical health, psychological, social relationships, and environment. Each item is scored on a five-point scale from 1 to 5, with varying response options across the domains, and some items need to be reversely scored. There are two items examined separately and will not be included in the score calculation. Domain scores are calculated by summing up the mean of all items in each domain and multiplying by four, and then the total score is transformed to a 0-100 scale to make the domains comparable. A higher the score indicates a higher QOL.

Baseline (before intervention), post-intervention (at 8 weeks), and follow-up (6 weeks post-intervention).

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。

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 (估计的)

2026年10月1日

初级完成 (估计的)

2027年1月31日

研究完成 (估计的)

2027年1月31日

研究注册日期

首次提交

2026年9月6日

首先提交符合 QC 标准的

2026年9月6日

首次发布 (实际的)

2026年9月11日

研究记录更新

最后更新发布 (实际的)

2026年9月11日

上次提交的符合 QC 标准的更新

2026年9月6日

最后验证

2026年9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

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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