Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT07118293
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-12
First Post:
2025-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Developing and Examine the Efficacy of the Family-Centered Multi-Sensory Environment Intervention on Parent's Empowerment and Children's Engagement (MSE-PEACE) in Children With Developmental Disabilities and Their Parents: A Mixed Methods Study
Sponsor:
National Cheng Kung University
Organization:
Study Overview
Official Title:
Developing and Examine the Efficacy of the Family-Centered Multi-Sensory Environment Intervention on Parent's Empowerment and Children's Engagement (MSE-PEACE) in Children With Developmental Disabilities and Their Parents: A Mixed Methods Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MSE-PEACE
Brief Summary:
The goal of this clinical trial is to learn whether a family-centered multi-sensory environment (MSE-PEACE) can help children with developmental disabilities and support their parents. The main questions it aims to answer are:
Can the MSE-PEACE program improve children's participation and emotional self-regulation? Does it help parents feel more confident and empowered in their caregiving role?
Participants will include children ages 3 to 12 years and their parents. All children have been diagnosed with a developmental disability such as autism, ADHD, or cerebral palsy. Participants will:
Join 10 multi-sensory sessions, held every 2 weeks, each lasting about 60 minutes Complete questionnaires and interviews before and after the sessions Receive support and suggestions for using sensory-based activities at home
This study will collect both survey and interview data to understand how the program affects children's daily functioning and how it supports parents' confidence and well-being.
Can the MSE-PEACE program improve children's participation and emotional self-regulation? Does it help parents feel more confident and empowered in their caregiving role?
Participants will include children ages 3 to 12 years and their parents. All children have been diagnosed with a developmental disability such as autism, ADHD, or cerebral palsy. Participants will:
Join 10 multi-sensory sessions, held every 2 weeks, each lasting about 60 minutes Complete questionnaires and interviews before and after the sessions Receive support and suggestions for using sensory-based activities at home
This study will collect both survey and interview data to understand how the program affects children's daily functioning and how it supports parents' confidence and well-being.
Detailed Description:
This quasi-experimental, single-group pretest-posttest mixed methods study examines the efficacy of a family-centered multi-sensory environment (MSE-PEACE) intervention for families of children with developmental disabilities (DD). The study is conducted at a multi-sensory therapy facility under the guidance of licensed occupational therapists, and aims to promote children's engagement and emotional self-regulation while strengthening parental empowerment and caregiving confidence.
The intervention integrates principles of sensory integration therapy with a family-centered approach, emphasizing shared decision-making, parent-child co-participation, and individualized sensory needs. The target population includes 20 children aged 3 to 12 years diagnosed with DD (e.g., autism spectrum disorder, ADHD, cerebral palsy, developmental delay) and their caregivers.
The MSE-PEACE program consists of 10 biweekly, 60-minute sessions delivered in a specialized sensory environment (e.g., "White Room" and "Rainbow Room"). Each session is tailored through therapist-family collaboration to meet the child's sensory profile and developmental goals. Parents are actively involved in each session and receive ongoing guidance on home-based sensory play and environmental adaptations.
Quantitative data will be collected pre- and post-intervention using validated tools to assess child outcomes (e.g., sensory processing, emotional regulation, functional participation) and parent outcomes (e.g., empowerment, parenting competence, stress, and parent-child relationship quality). Tools include the Short Sensory Profile 2, Emotion Regulation Checklist, Family Empowerment Scale, Parenting Stress Index, Parenting Sense of Competence Scale, and Parent-Child Relationship Inventory.
Qualitative data will be collected via semi-structured interviews with parents before and after the intervention. These interviews aim to capture parent experiences, perceptions of empowerment, interaction with service providers, and views on co-participation in therapy.
Quantitative analysis will involve paired t-tests to assess pre-post differences. Qualitative data will be analyzed using thematic analysis and integrated with quantitative results via joint displays, following a convergent mixed methods design.
The study expects to generate evidence for a practical and replicable family-centered sensory intervention model and to inform future community-based and home-based service designs for children with developmental disabilities.
The intervention integrates principles of sensory integration therapy with a family-centered approach, emphasizing shared decision-making, parent-child co-participation, and individualized sensory needs. The target population includes 20 children aged 3 to 12 years diagnosed with DD (e.g., autism spectrum disorder, ADHD, cerebral palsy, developmental delay) and their caregivers.
The MSE-PEACE program consists of 10 biweekly, 60-minute sessions delivered in a specialized sensory environment (e.g., "White Room" and "Rainbow Room"). Each session is tailored through therapist-family collaboration to meet the child's sensory profile and developmental goals. Parents are actively involved in each session and receive ongoing guidance on home-based sensory play and environmental adaptations.
Quantitative data will be collected pre- and post-intervention using validated tools to assess child outcomes (e.g., sensory processing, emotional regulation, functional participation) and parent outcomes (e.g., empowerment, parenting competence, stress, and parent-child relationship quality). Tools include the Short Sensory Profile 2, Emotion Regulation Checklist, Family Empowerment Scale, Parenting Stress Index, Parenting Sense of Competence Scale, and Parent-Child Relationship Inventory.
Qualitative data will be collected via semi-structured interviews with parents before and after the intervention. These interviews aim to capture parent experiences, perceptions of empowerment, interaction with service providers, and views on co-participation in therapy.
Quantitative analysis will involve paired t-tests to assess pre-post differences. Qualitative data will be analyzed using thematic analysis and integrated with quantitative results via joint displays, following a convergent mixed methods design.
The study expects to generate evidence for a practical and replicable family-centered sensory intervention model and to inform future community-based and home-based service designs for children with developmental disabilities.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: