- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06507358
Parent-Child Interaction in Garding Activities for Early Intervention Preschool Children
Exploring the Sensory Experiences and Enhancement of Parent-Child Interaction in Garding Activities for Early Intervention in Preschool Children
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Taiwan,
-
New Taipei City, Taiwan,, Taiwan, 235
- Taipei Medical University Shuang Ho Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parenting Stress Index: Short form,PSI/SF
Time Frame: 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.
|
Change from Baseline at 6 weeks
|
|
Parenting Sense of Confidence ,PSOC
Time Frame: 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.
|
Change from Baseline at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chinese Version of Pediatric Evaluation of Disability Invertory
Time Frame: Change from Baseline at 6 weeks
|
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
Time Frame: Change from Baseline at 6 weeks
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: ChiehYu Pan, Master, Taipei Medical University Shuang Ho Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- N202405063
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Development Delay
-
Children's Hospital of PhiladelphiaNational Institute on Minority Health and Health Disparities (NIMHD)CompletedDevelopment Delay | Development, ChildUnited States
-
Riphah International UniversityCompletedDevelopment DelayPakistan
-
Indonesia UniversityCompletedCommunication Disorders | Child Development | Developmental Delay | Infant Development | Development Delay | Child Development Disorder | Motor Delay | Global Developmental Delay | Speech DelayIndonesia
-
Indonesia UniversityCompletedChild Development | Developmental Delay | Development Delay | Child Development Disorder | Motor Delay | Global Developmental Delay | Speech DelayIndonesia
-
Shalamar Institute of Health SciencesNot yet recruiting
-
Chang Gung Memorial HospitalNational Taiwan Normal UniversityRecruitingGross Motor Development DelayTaiwan
-
Arkansas Colleges of Health EducationRecruiting
-
Emory UniversityCompletedGross Motor Development DelayUnited States
-
Ohio State UniversityActive, not recruitingGross Motor Development DelayUnited States
-
University of DelawareCompletedDevelopmental Delay | Infant DevelopmentUnited States
Clinical Trials on Parent-Child Interaction group
-
Florida International UniversityLotus HouseCompletedParenting | Behavior ProblemUnited States
-
Johns Hopkins UniversityNational Institute of Nursing Research (NINR); University of Iowa; Hugo W. Moser...Completed
-
Florida International UniversityCompletedParenting | Behavior Problem
-
University of PittsburghAutism SpeaksCompletedNoncomplianceUnited States
-
Centers for Disease Control and PreventionCompletedChild Externalizing ProblemsUnited States
-
Stony Brook UniversityUnknown
-
Riphah International UniversityCompletedLanguage DisorderPakistan
-
University of California, Los AngelesUnited States Department of DefenseCompletedTuberous SclerosisUnited States
-
University of OregonCompletedChild Abuse | Parenting | Self-controlUnited States
-
Norwegian University of Science and TechnologySt. Olavs HospitalCompletedConduct Disorder | Behavior Problems | Oppositional Defiant DisorderNorway