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临床试验/NCT05269693
NCT05269693已完成不适用

A Brief Hope Intervention to Increase Hope Level and Decrease Stress Level of Parents With Children With Medical Complexity in the Community? A Pilot RCT

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年12月1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
40
试验地点
1
主要终点
Intervention Delivery Rating Scale

研究概览

简要总结

Being a parent of a child with medical complexity (CMC) poses an enormous stress because these CMC have a multisystem disease, a severe neurologic condition or cancer which may result in premature death. Parents may feel challenged, lacking in confidence and high level of stress when managing their daily caregiving activities and child's new symptom. Literature suggested that hope is believed to be the central agent in facilitating positive psychological change when parents are facing difficulties and feeling stress. Brief Hope Intervention (BHI) is an alternative method considered to be feasible in improving parental hope level meanwhile, decreasing their stress level associated with daily caregiving activities. The purpose of BHI is to help these parents to develop workable goals, and concentrate on problem solving skill along with achievable planned actions in order to terminate the stressors associated from the caregiving activities.

This proposed pilot randomized controlled trial will test the feasibility and preliminary effect of the BHI in term of increasing the level of hope meanwhile decreasing the stress level of parents with a CMC. Eligibility, recruitment rates, and attrition rates will be collected in percentage to evaluate the feasibility of the study. Content analysis will be adopted to analysis the qualitative feedback on the acceptability of BHI from the parents. A repeated-measures, two-group design will be used to evaluate the preliminary effects between intervention and wait-listed control groups by comparing Brief Hope Intervention and wait-listed control groups receiving usual community care for 64 randomly selected parents over a 1-month follow-up. The outcome measures include parental hope and stress level. They will be measured before intervention, immediately after intervention and one-month after intervention.

With positive outcomes found in this study, this intervention will be implemented in a larger scale to improve local psychological health service for parents with a CMC.

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
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Parents of a CMC will be recruited via the special schools for the children with physical disabilities. The eligible criteria for parents are
  • one of the parent of a child with medical complexity aged 5-18,
  • able to communicate in Chinese and read Chinese,
  • willing to participate in face-to-face activities and a telephone follow-up,
  • alert and oriented, able to sustain approximately 1 hour of attention and interaction, and
  • able to be reached by phone.

排除标准

  • Parents are
  • a reported mental health disorder,
  • inability to communicate in Cantonese,
  • engaging in other Hope Therapy related to stress relief and hope enhancement, and
  • severe hearing deficit that prevented them from engaging in phone communication.

结局指标

主要结局

Intervention Delivery Rating Scale

时间窗: Week 4

5-point Likert scale for evaluating the useful level of intervention, ranging from 1 (not at all) to 5 (most).Higher scores mean more better outcome.

Change of Hope Level

时间窗: Week 0, Week 4, Week 8

State Hope Scale (Chinese version): consisting of 6 items. Each item is rated on a 8-point scale, with 1 = definitely false and 8 = definitely true. Higher scores mean higher hope level.

Change of Stress Level

时间窗: Week 0, Week 4, Week 8

Perceived Stress Scale (Chinese version): consisting of 14 items. Each item is rated on a 5-point scale, ranging from 1 (not at all) to 5 (extremely). Higher scores mean higher stress level.

Recruitment

时间窗: Week 4

Enrollment and dropout rates will be calculated for each participant and summarized for all participants in the study

次要结局

未报告次要终点

研究者

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

Dr Winsome Lam

Assistant Professor

The Hong Kong Polytechnic University

研究点 (1)

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