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临床试验/NCT06166550
NCT06166550进行中(未招募)不适用

Improving Psychological Wellbeing Through Stress Reduction Among Parents Having Children With Neurodevelopmental Disorders: A Multi-pronged Intervention in Bangladesh

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh2 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2024年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
480
试验地点
2
主要终点
Psychological well-being

研究概览

简要总结

This project addresses the mental health challenges faced by parents caring for children with Neurodevelopmental Disorders (NDDs) in Bangladesh. These parents often experience high levels of stress, anxiety, and depression, impacting family dynamics and the child's development. The project aims to design, implement, and assess an intervention to reduce parenting stress and enhance parental well-being. This intervention focuses on emotional intelligence and will be delivered through in-person training and a mobile app. The study will use a cluster randomized controlled trial methodology, targeting parents of children diagnosed with NDDs.

The study will be conducted in Child Development Centers in public medical college hospitals across Bangladesh. It will assess changes in parental stress, mental well-being, and emotional intelligence. Data collection will occur from January 2024 to June 2025.

The project aims to recruit 480 parents from eight Child Development Centers, ensuring ethical considerations, data integrity, and participant privacy. The findings will be shared through national dissemination seminars, policy briefs, reports, and journal publications.

详细描述

Background and Rationale:

Neurodevelopmental disorders (NDDs) are a global public health concern, often causing parents to grapple with increased stress, anxiety, and reduced well-being. This compromised mental health among caregivers persists throughout a child's development, straining family dynamics and making effective parenting more challenging. Research underscores the importance of addressing caregiver's well-being, as it indirectly impacts the child's health and development.

In Bangladesh, where social stigma and limited support exacerbate the challenges, there is a lack of research on stress management to improve parental well-being. Empirical studies are essential to enhance the psychological health of caregivers of children with NDDs in Bangladesh and promote long-term caregiving abilities.

Objectives:

The project aims to develop an evidence-based intervention to reduce parenting stress and enhance the mental health of parents with children with neurodevelopmental disorders. This intervention will be implemented in healthcare and community settings and evaluated through process and outcome measures, including changes in parenting stress.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The arms will be labelled as group A and group B. The statisticians will be blind about the labelling. Thus, the masking will be ensured.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Parents of any age having children with neurodevelopmental disorders i.e. Autism Spectrum Disorders, Cerebral Palsy, Intellectual disorders, attention deficit hyperactivity disorders, and Down Syndrome.
  • Parents of children whose diagnosis were made within one year (to avoid the time-effect on stress and mental health).
  • Parents' age limit will be 18-50 years

排除标准

  • Parents having children with serious sensory impairments (e.g., deafness and blindness) and oxygen dependence due to chronic lung diseases.
  • Parents who need pharmacological management at initial assessment.

结局指标

主要结局

Psychological well-being

时间窗: 12 weeks after completion of the intervention

Psychological well-being: The WHO-5 Well-Being Index will assess participants' subjective well-being before and after the intervention. Raw scores range from 0 to 25, with higher scores indicating better well-being.

Parenting stress

时间窗: 12 weeks after completion of two-day intervention

Parenting stress will be assessed by Parental Stress Scale, a 18-item Likert scale. Parental stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress.

Mental Health

时间窗: 12 weeks after the intervention.

Mental health will be assessed using Depression, Anxiety, and Stress scale (DASS-9), a validated screening tool measuring depression, anxiety, and stress. Raw score ranges from 0 to 27, with higher score indicating more depression, anxiety, and stress.

次要结局

  • Emotional intelligence(12 weeks after completion of the intervention)
  • Parenting Self-Efficacy(12 weeks after completion of two-day intervention)
  • Parenting satisfaction(12 weeks after the completion of the intervention)
  • Marital satisfaction(12 weeks after the intervention)
  • Fidelity(Perioperative.)

研究者

发起方
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Md Atiqul Haque

Dean and Chairman

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

研究点 (2)

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