Parent-Child Interaction in Garding Activities for Early Intervention Preschool Children
NCT Number: NCT06507358
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Development Delay
Interventions: BEHAVIORAL: Parent-Child Interaction group
Sponsor: Taipei Medical University Shuang Ho Hospital
Sex: ALL
Age: CHILD
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-12
Completion Date: 2025-05-23
Locations: Taipei Medical University Shuang Ho Hospital, New Taipei City, Taiwan,, 235, Taiwan

Summary:
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.

Primary Outcome Measures: Parenting Stress Index: Short form，PSI/SF, 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., Change from Baseline at 6 weeks|Parenting Sense of Confidence ，PSOC, 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., Change from Baseline at 6 weeks
Secondary Outcome Measures: Chinese Version of Pediatric Evaluation of Disability Invertory, This tool is designed for functional assessment of children aged 6 months to 7 years and 6 months. It includes three different domains for evaluation. Given the study's focus on changes in children's participation and interaction abilities pre and post intervention, emphasis is placed on comparing the social functioning domain of the Functional Skills Assessment. Items assess abilities in communication, social interaction, household tasks, and community activities., Change from Baseline at 6 weeks|The Sensory Integration Functional Assessment Scale, It is designed for caregivers of children aged 3 to 10 years and 11 months. It assesses various aspects including postural and movement abilities, bilateral integration and sequencing of movements, sensory discrimination, sensory modulation, sensory seeking behaviors, attention and activity levels, and emotional/behavioral responses. The scale utilizes a five-point Likert scale and includes detailed items to evaluate children's performance across seven subscales., Change from Baseline at 6 weeks