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临床试验/NCT04919330
NCT04919330已完成不适用

Embodying a Compassionate Self Through Acceptance and Commitment Therapy for Parents and Children With Eczema: A Family Based Eczema Management Programme

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2021年7月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
2
主要终点
Child's eczema severity

研究概览

简要总结

This pilot randomised wait-list controlled trial aims to determine the feasibility, acceptability and preliminary effects of a Family Acceptance and Commitment Therapy-based Eczema Management Programme (FACT-EMP) on the health outcomes of both children patients and their main caregivers over a 3-month post-intervention.

详细描述

Background:

Eczema is the most common paediatric skin condition affecting 15-20% children worldwide and 30% of children in Hong Kong. The highly visible nature of eczema symptoms that deviate from the individual's idealized body image could compromise his/her sense of self, leading to feelings of body image disturbance. It has been reported that children may use their illness to avoid schools, experience low self-esteem, shame and guilt and even stigmatization. In addition, their parents experience high level of stress in caring for their children with eczema, can easily generate shame and guilt feelings if they perceive themselves not performing satisfactory parenting roles in safeguarding their child's health. One emerging therapeutic approach to managing body-image concern, psychological difficulties associated with self-criticism and shame is by fostering self-compassion.

This study is a pilot randomized controlled trial aiming at examining the effects of a family-based eczema management programme in Hong Kong utilizing Acceptance and Commitment Therapy (ACT) to foster self-compassion of parents and their children affected by eczema. It is expected that fostering self-compassion could empower the parent-child dyads in cultivating a more loving, kind and forgiving attitude towards eczema, leading to improved motivation for self-care and better health outcomes. If found effective, the programme can improve the lives of many local families with children living with eczema through addressing their unmet psychological needs. In addition, the programme can be incorporated into current service in hospitals and community settings in Hong Kong and other Chinese communities.

Aim and hypothesis to be tested:

The proposed study will use a single-blinded, pilot randomized wait-list controlled trial design to determine the feasibility, acceptability and preliminary effects of a family ACT-based eczema management programme (FACT-EMP) on the health outcomes of both parent caregivers and children with eczema over 3-month post-intervention. It is hypothesized that when compared with a wait-list control group receiving standard care, the participants of the programme can show significant improvements in:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Outcome assessors and researchers (and health care staff of the study hospital) are blind to the group assignment and intervention undertaken and concealed to the participant list.

入排标准

年龄范围
6 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Child's eczema severity

时间窗: Change from baseline to 3 months post-intervention

The Severity scoring of atopic dermatitis (SCORAD) will be used to assess the severity of childhood eczema, including the extent and intensity of the disease, and the degree of itching and sleep disturbance (Rehal et al., 2011).

Parent's self-efficacy of eczema management

时间窗: Change from baseline to 3 months post-intervention

The 29-item Chinese Version of Parental Self-Efficacy with Eczema Care Index (PASECI; Cheng et al., 2020) will be adopted to assess the parents' self-efficacy for performing eczema management tasks, managing the child's symptoms and behavior. The PASECI is arranged in 4 subscales: Managing Medication, Managing Eczema and Symptoms, Communicating with Health Professionals, and Managing Personal Challenges. Each item is scored on an 11-point Linkert scale, ranging from 0 (Cannot do at all) to 10 (Highly certain can do it). The scores of PASECI are gained by adding items up. The higher the PASECI score, the greater the parental self-efficacy in respective scales. The PASECI possessed high internal consistency (α=.97), test-retest reliability (ICC =.93-.99), and acceptable convergent validity in the Hong Kong population.

次要结局

  • Child's self-compassion(Change from baseline to 3 months post-intervention)
  • Parent's psychological flexibility(Change from baseline to 3 months post-intervention)
  • Parent's symptoms of depression, anxiety and stress(Change from baseline to 3 months post-intervention)
  • Parent's self-compassion(Change from baseline to 3 months post-intervention)
  • Child's quality of life(Change from baseline to 3 months post-intervention)
  • Child's psychological flexibility(Change from baseline to 3 months post-intervention)
  • Parent's quality of life.(Change from baseline to 3 months post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuen Yu CHONG

Assistant Professor

Chinese University of Hong Kong

研究点 (2)

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