Development DelayNCT06507358
Parent-Child Interaction in Garding Activities for Early Intervention Preschool Children
A study testing Parent-Child Interaction group in people with Development Delay, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Development Delay
- What is being tested?
- Parent-Child Interaction group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Jun 2024to 23 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Children don't accept early intervention.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Medical University Shuang Ho Hospital
New Taipei City, Taiwan, 235
About this study
Official title: Exploring the Sensory Experiences and Enhancement of Parent-Child Interaction in Garding Activities for Early Intervention in Preschool Children
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.
Read the 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
- Being tested
- Parent-Child Interaction group
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Child Interaction groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from Baseline at 6 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: Change from Baseline at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start12 Jun 2024
- Primary completion23 Mar 2025
- Study completion23 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development DelayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ChiehYu Pan, Master, Principal investigator, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06507358
- Sponsor's protocol ID
- N202405063
- Status last verified
- May 2024
- First submitted
- 10 Jul 2024
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Sensory Experiences and Enhancement of Parent-Child Interaction in Garding Activities for Early Intervention in Preschool Children
- ClinicalTrials.gov ID
- NCT06507358
- Acronym / sponsor ID
- N202405063
- Conditions
- Development Delay
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 23 Mar 2025 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Parent-Child Interaction group | Experimental | Behavioral: Parent-Child Interaction groupInclusion 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. |
| 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. |
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Children don't accept early intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent-Child Interaction groupThe 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. | Behavioural | Parent-Child Interaction group |
Primary outcome
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.
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.
2 secondary outcomes
Chinese Version of Pediatric Evaluation of Disability Invertory
Time frame: Change from Baseline at 6 weeks
The Sensory Integration Functional Assessment Scale
Time frame: Change from Baseline at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ChiehYu Pan, Master principal investigator
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-Child Interaction group in people with Development Delay, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parenting Stress Index: Short form，PSI/SF (time frame: Change from Baseline at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.