Parent-Child Interaction in Garding Activities for Early Intervention Preschool Children

NCT ID: NCT06507358

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-12
• Study Completion Date: 2025-05-23

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.

Conditions

Development Delay

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Parent-Child Interaction group

Inclusion criteria for the experimental group are as follows: (1) Children currently undergoing early intervention; (2) Children experiencing sensory processing issues and caregivers (including grandparents and great-grandparents) seeking to establish parent-child relationships or enhance self-efficacy; (3) Ability to participate on duration of interventive class and to comply with trial procedures and complete home assignments, having attended at least 3/4 of the sessions.

Group Type: EXPERIMENTAL

Parent-Child Interaction group

Intervention Type: BEHAVIORAL

The intervention for the Parent-Child Interaction group consists of a 6-week program involving weekly 40-minute sessions of therapeutic horticulture in a group setting, with 4-6 participants per group. The sessions focus on sensory-motor activities aimed at helping children engage in daily tasks and activities. Various sensory stimuli are provided through different materials used in gardening activities, including visual, auditory, gustatory, tactile, and olfactory stimuli. The program encourages mutual support and sharing among group members, showcases different outcomes, and emphasizes a sense of responsibility for home care. With a family-centered approach, parental involvement serves as a mediator to promote children's overall development and abilities. Participants are required to complete homework assignments and maintain activity records, including documentation of the 6 sessions through photos and written records.

Control group

Exclusion criteria for study participants are as follows: (1) Children aged under 4 or over 7 years; (2) Caregivers (including grandparents and great-grandparents) unable to communicate or read in Chinese. (3) Inability to participate on duration of interventive class.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Parent-Child Interaction group

The intervention for the Parent-Child Interaction group consists of a 6-week program involving weekly 40-minute sessions of therapeutic horticulture in a group setting, with 4-6 participants per group. The sessions focus on sensory-motor activities aimed at helping children engage in daily tasks and activities. Various sensory stimuli are provided through different materials used in gardening activities, including visual, auditory, gustatory, tactile, and olfactory stimuli. The program encourages mutual support and sharing among group members, showcases different outcomes, and emphasizes a sense of responsibility for home care. With a family-centered approach, parental involvement serves as a mediator to promote children's overall development and abilities. Participants are required to complete homework assignments and maintain activity records, including documentation of the 6 sessions through photos and written records.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University Shuang Ho Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ChiehYu Pan, Master

Role: PRINCIPAL_INVESTIGATOR

Taipei Medical University Shuang Ho Hospital

Locations

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

N202405063

Identifier Type: -

Identifier Source: org_study_id