Clinical trial NCT06507358: Parent-Child Interaction in Garding Activities for Early Intervention Preschool Children
Official title: Exploring the Sensory Experiences and Enhancement of Parent-Child Interaction in Garding Activities for Early Intervention in Preschool Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Development Delay
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A sampling will assign participants equally to a gardening group (Parent-Child Interaction) (N=30) and a waiting group (N=30). The gardening group (Parent-Child Interaction) will participate in group gardening activities for six to eight weeks, while the waiting group will join after eight-weeks waiting period.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Children don't accept early intervention.

Primary outcomes:
measure: Parenting Stress Index: Short form，PSI/SF
timeFrame: Change from Baseline at 6 weeks
measure: Parenting Sense of Confidence ，PSOC
timeFrame: Change from Baseline at 6 weeks
Secondary outcomes:
measure: Chinese Version of Pediatric Evaluation of Disability Invertory
timeFrame: Change from Baseline at 6 weeks
measure: The Sensory Integration Functional Assessment Scale
timeFrame: Change from Baseline at 6 weeks
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
state: Taiwan,
Study officials:
affiliation: Taipei Medical University Shuang Ho Hospital
name: ChiehYu Pan, Master
role: PRINCIPAL_INVESTIGATOR
References: