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

NCT06507358 | Completed

• 1 other identifier: N202405063
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Development Delay

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

Parent-Child Interaction group

EXPERIMENTAL

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.

Behavioral: Parent-Child Interaction group

Control group

NO INTERVENTION

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.

Interventions

Parent-Child Interaction group 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.

Parent-Child Interaction group

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children don't accept early intervention.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan, 235, Taiwan

Location

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• ChiehYu Pan, Master

  Taipei Medical University Shuang Ho Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 18, 2024
• Study Start: June 12, 2024
• Primary Completion: March 23, 2025
• Study Completion: May 23, 2025
• Last Updated: July 8, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)