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临床试验/NCT06507358
NCT06507358已完成不适用

Exploring the Sensory Experiences and Enhancement of Parent-Child Interaction in Garding Activities for Early Intervention in Preschool Children

Taipei Medical University Shuang Ho Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Parenting Sense of Confidence ,PSOC

研究概览

简要总结

Post-COVID-19, children's reduced interaction with nature has hindered their sensory development, particularly affecting those with developmental delays. This creates challenges for caregivers and impacts the children's abilities and parental mental health. While caregiver-centered interventions are known to benefit child development and reduce parent stress, there is a lack of such multidisciplinary programs in early intervention practices. This project investigates the impact of gardening activities on caregiver stress, self-efficacy, relationships, and parent-child conflict. Caregivers of children in early intervention in northern outpatient clinics will be recruited and randomly assigned to a gardening group or a waiting group. The gardening group will participate in activities for six to eight weeks, with assessments conducted before and after the intervention using various scales. Data will be analyzed using SPSS (Version 20.0) with a 0.05 significance level. Results will be shown as mean ± standard deviation. Descriptive statistics will analyze basic data and assessment items. The Chi-square test, Mann-Whitney U test, and Kruskal-Wallis ANOVA will compare outcomes. Spearman's rank correlation will assess relationships between caregivers' and children's data, caregiver efficacy, stress, and children's sensory interaction.

详细描述

Background:Following the COVID-19 pandemic, children have had significantly reduced interactions with nature, leading to a lack of sensory experiences crucial for their development. This issue is particularly detrimental to children with developmental delays, posing greater challenges for caregivers. These children often have fewer opportunities for therapy, education, and life participation, negatively affecting both the children's abilities and parental mental health. Research supports caregiver-centered interventions as beneficial for child development, reducing parent stress, and enhancing self-efficacy. However, there is a lack of multidisciplinary, relationship-enhancing programs for caregivers of children with developmental delays in early intervention clinical practice.

Purpose:This project aims to explore the effects of 'horticultural mediums', 'sensory experiences', and 'language guidance' on caregiver stress, self-efficacy, relationships, and parent-child conflict by involving both parents and children in gardening activities. Caregivers of children currently undergoing early intervention in outpatient clinics in the northern region will be recruited. Participants will be randomly assigned to either a gardening group (N=30) or a waiting group (N=30). The gardening group will engage in group gardening activities for six to eight weeks, while the waiting group will participate after an eight-week waiting period. Assessments before and after the intervention will include the Parental Competence Scale, Parenting Stress Index (Short Form), Pediatric Evaluation of Disability Inventory, and The Development of the Sensory Integration Functions Assessment Scale.

Data Analysis:The research data will be analyzed using SPSS (Version 20.0) with a significance level of 0.05. Results will be presented as mean ± standard deviation. Descriptive statistics will analyze basic data and assessment items of both groups. The Chi-square test will compare categorical data, while the Mann-Whitney U test and Kruskal-Wallis one-way ANOVA will compare outcomes within and between groups. Spearman's rank correlation will examine relationships between caregivers' and children's data, caregiver efficacy, stress, and children's sensory interaction.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children currently undergoing early intervention;
  • Children experiencing sensory processing issues and caregivers (including grandparents and great-grandparents) seeking to establish parent-child relationships or enhance self-efficacy

排除标准

  • Children don't accept early intervention.

结局指标

主要结局

Parenting Sense of Confidence ,PSOC

时间窗: Change from Baseline at 6 weeks

This tool assesses parents' confidence and satisfaction in their role as caregivers, comprising 17 items rated on a 6-point Likert scale ranging from "1" (strongly agree) to "6" (strongly disagree), where higher scores indicate greater parental confidence. The scale demonstrates good internal consistency with an alpha coefficient of 0.82. It consists of two subscales: "Parenting Sense of Competence - Efficiency" (PSOC-E), which reflects feelings of frustration, anxiety, and motivation, and "Parenting Sense of Competence - Satisfaction" (PSOC-S), which assesses abilities, problem-solving skills, and satisfaction in the parental role.

Parenting Stress Index: Short form,PSI/SF

时间窗: Change from Baseline at 6 weeks

It designed for parents of children aged 0-12 years old in households experiencing parental stress, including parental distress, dysfunctional parent-child interaction, and difficult child behaviors. It consists of 36 items and has undergone factor analysis to establish content validity and construct validity. Each item on the scale demonstrates factor loadings greater than .30. The internal consistency of the entire scale ranges from .856 to .908 across its subscales, with a total scale reliability of .947, indicating high consistency in measuring the assessed content.

次要结局

  • Chinese Version of Pediatric Evaluation of Disability Invertory(Change from Baseline at 6 weeks)
  • The Sensory Integration Functional Assessment Scale(Change from Baseline at 6 weeks)

研究者

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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