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临床试验/NCT06262646
NCT06262646已完成不适用

Effectiveness of Video-conferencing Focused Acceptance and Commitment Therapy Compared With Standard Parenting Advice for Parents of Young Children With Special Needs: A Randomized Clinical Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 254 人开始时间: 2024年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
254
试验地点
1
主要终点
Parenting stress

研究概览

简要总结

Objective: This RCT evaluates the efficacy of Focused Acceptance and Commitment Therapy (FACT) delivered via videoconferencing for parents of special needs children, targeting reducing parental stress (primary outcome), symptoms of depression and anxiety, as well as psychological flexibility.

Background: Parental caregiving for children with special needs is associated with significant stress, potentially impairing parental and familial functioning. Acceptance and Commitment Therapy (ACT) has shown promise in bolstering mental health across diverse populations. Preliminary findings from a feasibility trial (NCT05803252) suggest the potential of FACT in this context.

Methods: Expanding upon prior research, this definitive RCT compares FACT to standard parenting advice, correcting for earlier limitations through increased sample size and rigorous methodology. Assessments will be conducted at baseline, post-intervention (4-8 weeks), and 6-month follow-up.

Results: The study anticipates that FACT will demonstrate superior outcomes in promoting well-being among parents compared to parenting advice alone.

Conclusion: By leveraging videoconferencing for therapy delivery, the RCT aims to improve access to mental health interventions and emphasize the importance of psychological health among parents of special needs children. This could foster greater recognition and proactive management of mental health within this population.

详细描述

INTRODUCTION Children with special health care needs (SHCN) are defined as those who have/are at high risk for having chronic physical, developmental, behavioural, and/or emotional conditions requiring specialized and considerable health and related services of type(s)/amount beyond 12 months. Although there is no central registry for children with SHCN in Hong Kong, for pre-schoolers with developmental conditions, there has been a prevailing rate of newly diagnosed cases of special health care needs children in Hong Kong (17,193 in 2019) and an annual increase rate of 6.2-10.7% in the number of referred cases for speciality follow-up services in the Child Assessment Centre under the Department of Health.

Parents of children with special health care needs (SHCN) have always been under tremendous pressure to take care of their children. They have been experiencing significant caregiving difficulties, such as scheduling and accompanying multiple follow-ups for rehabilitation and functional recovery and managing a child's symptoms and problematic behaviours. In addition, parenting stress has been known to affect parent-child interactions, increase negative parenting behaviours such as harsh, permissive, or neglectful parenting, and impair the parent's capacity to respond to the demands of the child's illness, which may, in turn, exacerbate the child's health problem and well-being. The above shows an emerging need to provide and expand mental health care support to these parents and children in a format that is sustainable and undisrupted by the restriction measures caused by the pandemic.

In literature, there has been increasing evidence supporting the efficacy of Acceptance and Commitment Therapy (ACT) on mental health in different population groups, including healthy individuals, parents, children, and those with mental health problems. Though the result was promising, the previous clinical trials in Hong Kong showed a limited effect size. This is due to the need for extensive manpower in ACT intervention, yet there are very limited trained ACT interventionists in Hong Kong. On top of that, past interventions have failed to target impaired psychopathological processes as well as identify and determine which psychopathological processes require intervention in the first place. This study aims to overcome the limitations mentioned above.

BACKGROUND Acceptance and Commitment Therapy Acceptance and Commitment Therapy (ACT) is a new form of mindfulness- and values-based behavioural therapy. In literature, ACT has demonstrated proven efficacy on the mental health symptoms of people diagnosed with depression and anxiety, as well as parents of children with developmental conditions (e.g., autism spectrum disorders and developmental delays).

The PI and her research team have conducted the first ACT clinical trial for Hong Kong parents of children with asthma, showing that a 4-session parental training programme using group-based ACT integrated with asthma education was more effective than education alone for improving parental psychological well-being, parental asthma management self-efficacy and childhood asthma morbidity. Currently, the PI's team is actively expanding the research studies in ACT to other population groups in Hong Kong, such as parents and their children with asthma comorbid with ADHD, parents of children with autism spectrum disorder, parents and their children with eczema and patients with early psychosis. In addition, our team has extensive experience in conducting clinical trials using mindfulness-based interventions for family caregivers and/or individuals with schizophrenia and dementia, as well as evaluating the efficacy of self-help programmes for facilitating patients with recent-onset psychosis to acquire better problem-solving abilities.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

Eligible parents consenting to participate will be randomly assigned to either the FACT or Control Group in a 1:1 ratio, using the permuted block size of 6 through sequentially numbered, opaque and sealed envelopes with number cards (1=intervention, 2=control). A separate set of random numbers, concealed from the research team and RAs, will be generated by a statistician. Clerical staff uninvolved in the project will administer the randomisation. The research assistant (RA-1), blinded to subject selection, will open the envelopes only after informed consent and baseline assessments are completed. The research assistant (RA-2) is also blinded to group assignments and will conduct assessments/evaluations.

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Language and Residency: Must be a Cantonese-speaking Hong Kong resident aged 21 years or older.
  • •Child's age and health status: Must be cohabiting with a preschool or school-aged child (2-9 years old) diagnosed with or suspected of having special needs.
  • •Caregiver role: Must be the primary caregiver responsible for daily care for the child.
  • •Technology access: Must have daily access to a smartphone, with either an iPhone or Android operating system, to participate in the study and for potential app-based interventions or communications.

排除标准

  • •Any parents with severe mental illness, are pregnant, are less than six months postpartum, or have a developmental disability that interferes with their ability to comprehend the programme's content.

研究组 & 干预措施

FACT Group

Experimental

Parents will receive 4-6 FACT consultation sessions, one weekly session, 45-60 mins per session. These sessions will be one-on-one, conducted face-to-face or via video conferencing.

干预措施: Focused Acceptance and Commitment Therapy (Behavioral)

Control Group

Active Comparator

Parents will receive standard parenting advice about positive parenting tips recommended by the Child Assessment Services under the Department of Health.

干预措施: Control Group (Other)

结局指标

主要结局

Parenting stress

时间窗: Change from baseline to immediate and 6 months post-intervention

The Parental Stress Scale (PSS, 18-item, 5-point scale) will be used to assess parenting stress. A higher score represents a higher level of parental stress. The Chinese version of the PSS has demonstrated acceptable psychometric properties and is therefore suitable for use by researchers to assess the parental stress levels of Chinese parents.

次要结局

  • Parental Psychological Flexibility(Change from baseline to immediate and 6 months post-intervention)
  • Parental depressive symptoms(Change from baseline to immediate and 6 months post-intervention)
  • Parental anxiety symptoms(Change from baseline to immediate and 6 months post-intervention)
  • ACT Core Process Utilization(Change from baseline to immediate and 6 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 (1)

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