Developmental DisabilityMSE-PEACENCT07118293
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
A study testing MSE-PEACE in people with Developmental Disability, run by National Cheng Kung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Disability
- What is being tested?
- MSE-PEACE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 3 to 12 years
- Diagnosed with a developmental disability (e.g., autism spectrum disorder, attention-deficit/hyperactivity disorder, cerebral palsy, global developmental delay)
- Able to attend 10 biweekly intervention sessions in person with a caregiver
- Caregiver is the primary caregiver and agrees to actively participate in all sessions
- Caregiver is able to complete written questionnaires in Chinese
- Caregiver provides informed consent
Who cannot join
- Child has significant physical or behavioral challenges that prevent safe participation in a multi-sensory therapy setting (e.g., uncontrollable aggression, high seizure risk)
- Caregiver has cognitive or psychiatric conditions that significantly limit the ability to participate in shared sessions or complete questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Department of Occupational Therapy, National Cheng Kung University
Tainan
About this study
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?
Read more
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.
Read the 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.
- Conditions
- Developmental Disability
- Being tested
- MSE-PEACE
- Keywords
- Developmental Disabilities, Family-Centered Intervention, Multi-Sensory Environment, Parent Empowerment, Occupational Therapy, Child Engagement, Mixed Methods
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSE-PEACEBehavioural
The MSE-PEACE (Multi-Sensory Environment-Parent Empowerment and Child Engagement) intervention is a family-centered, therapist-guided sensory integration program specifically developed for children with developmental disabilities and their caregivers. Unlike traditional child-only sensory therapies, this intervention actively involves parents in all stages-assessment, goal setting, activity participation, and follow-up.
Each participant dyad (parent and child) attends 10 biweekly sessions (60 minutes each) in a structured sensory therapy space equipped with adjustable lighting, tactile materials, auditory inputs, and other multisensory tools. The intervention is tailored to each child's sensory processing profile and emotional regulation needs, while promoting parent-child co-regulation, bonding, and collaborative engagement.
Occupational therapists facilitate the sessions using individualized strategies to support child-led participation and empower parents with real-time coaching,
| Study group | Role | What they receive |
|---|---|---|
| MSE-PEACE Group | Experimental | Participants in this arm will receive the MSE-PEACE intervention, a family-centered multi-sensory environment program designed for children with developmental disabilities and their caregivers. The intervention includes 10 sessions delivered every 2 weeks, with each session lasting approximately 60 minutes. Sessions take place in a specialized sensory therapy room and are guided by certified occupational therapists.
The intervention combines sensory-based activities with active parent-child co-participation. Each session is tailored to the child's sensory profile and developmental needs. Parents are engaged in goal-setting, activity participation, and follow-up support, including suggestions for home-based sensory activities and environmental adaptations. The program aims to improve children's functional engagement and emotional regulation, while enhancing caregiver empowerment, parenting competence, and family well-being. Receives: Behavioral: MSE-PEACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Volitional Questionnaire (Chinese version)
The Pediatric Volitional Questionnaire (PVQ), adapted from the Volitional Questionnaire, is used to assess a child's motivation and engagement in different environments. It consists of 14 observational items such as curiosity, task initiation, persistence, and problem solving. Each item is scored on a 4-point scale from "Passive" to "Spontaneous." The scores range from 14 to 56, higher scores mean better engagement. Observations are conducted during 15-30 minutes of free play in natural settings (e.g., therapy room, playground, or home). The PVQ has demonstrated strong reliability and validity in children with developmental delays, with an item separation reliability coefficient of 0.97. This study uses the PVQ to evaluate changes in children's volitional behavior and functional participation before and after the MSE-PEACE intervention.
Measured: At baseline (within 1 week before the first intervention session) and immediately after completion of the 10th session (within 1 week)
Short Sensory Profile 2 - Chinese Version (SSP-2)
The Short Sensory Profile 2 (SSP-2) is a 34-item caregiver-reported questionnaire used to evaluate sensory processing patterns in children aged 3 to 14 years. It assesses four sensory quadrants: sensory seeking, sensory avoiding, sensory sensitivity, and low registration (observer). Caregivers rate each item based on the child's typical behavior in daily life using a 5-point Likert scale (1 = Almost Never to 5 = Almost Always). Higher scores within each quadrant indicate greater difficulties in sensory processing according to age norms.
The Chinese version of SSP-2 has been translated and validated in prior studies, showing strong internal consistency (Cronbach's α = 0.949). This study uses the SSP-2 to assess changes in children's sensory processing patterns before and after the MSE-PEACE intervention.
Measured: At baseline (within 1 week before the first intervention session) and immediately after completion of the 10th session (within 1 week)
Emotion Regulation Checklist - Chinese Version (ERC)
The Emotion Regulation Checklist (ERC) is a 24-item parent-report measure used to evaluate children's emotion regulation abilities. Parents rate how frequently their child demonstrates specific emotional behaviors in daily life using a 4-point Likert scale (1 = Never to 4 = Almost Always). The ERC includes two subscales: Emotion Regulation (ERC-ER), which reflects a child's ability to understand and express emotions appropriately, and Lability/Negativity (ERC-L/N), which reflects emotional dysregulation and instability. Higher ERC-ER scores indicate better emotion regulation, while higher ERC-L/N scores indicate greater emotional dysregulation.
The Chinese version has shown acceptable internal consistency, with Cronbach's α values of 0.88 (ERC-ER) and 0.64 (ERC-L/N). This study uses the ERC to assess changes in children's emotional self-regulation following the MSE-PEACE intervention.
Measured: At baseline (within 1 week before the first intervention session) and immediately after completion of the 10th session (within 1 week)
Family Empowerment Scale - Chinese Version (FES)
The Family Empowerment Scale (FES) is a 34-item self-report questionnaire designed to measure caregivers' perceptions of their empowerment when raising a child with disabilities. It evaluates empowerment across three domains: Family (12 items), Service System (12 items), and Community/Political (10 items). Respondents rate items using a 6-point Likert scale from 0 ("Not applicable") to 5 ("Very often"), with higher scores indicating higher levels of perceived empowerment.
The Chinese version used in this study was translated using a forward-backward translation process, reviewed by an expert panel, and pre-tested with caregivers for clarity and cultural relevance. The original FES demonstrates strong psychometric properties, including internal consistency reliability coefficients of 0.88, 0.87, and 0.88 across the three subscales, and test-retest reliabilities of 0.83, 0.77, and 0.85, respectively.
Measured: At baseline (within 1 week before the first intervention session) and immediately after completion of the 10th session (within 1 week)
Parenting Sense of Competence Scale - Chinese Version (PSOC)
The Parenting Sense of Competence Scale - Chinese Version (PSOC) is a 17-item self-report questionnaire used to assess parents' perceptions of their competence in the parenting role. The scale includes two subscales: (1) Parenting Efficacy (skills and knowledge) and (2) Parenting Satisfaction (comfort and value). Responses are rated on a Likert scale from 1 to 6, higher scores reflect better sense of competence that parents feel about their caregiving.
The Chinese version of the PSOC has demonstrated good psychometric properties, including internal consistency (Cronbach's α = .85) and test-retest reliability (intraclass correlation coefficient = .87). It also shows construct validity through correlations with measures of self-esteem and postpartum depression.
This study uses the PSOC to evaluate changes in parenting confidence and satisfaction following participation in the MSE-PEACE intervention.
Measured: At baseline (within 1 week before the first intervention session) and immediately after completion of the 10th session (within 1 week)
Parenting Stress Index - Fourth Edition Short Form (Chinese Version) (PSI-4-SF)
The Parenting Stress Index, Fourth Edition Short Form (Chinese Version) (PSI-4-SF) is a 36-item self-report questionnaire used to assess the level and sources of stress parents experience in their caregiving role. It includes three subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. The tool helps identify whether parenting stress stems from parent characteristics, child characteristics, or the relationship between parent and child. Higher scores reflected a greater sense of stress in parenting.
The Chinese version used in this study demonstrated strong psychometric properties, with internal consistency coefficients ranging from 0.92 to 0.95 across subscales and 0.97 for the total scale. Factor analysis supported the consistency of the translated scale structure with the original.
This study uses the PSI-4-SF to examine changes in parenting stress levels and contributing factors before and after the MSE-PEACE.
Measured: At baseline (within 1 week before the first intervention session) and immediately after completion of the 10th session (within 1 week)
Secondary outcomes (2)
Parent-Child Relationship Inventory - Chinese Version (PCRI)
The Parent-Child Relationship Inventory (PCRI) is a 78-item parent-report questionnaire designed to assess the quality of the parent's relationship with their child. Items are rated on a 4-point Likert scale from "Strongly Agree" to "Strongly Disagree," including some reverse-scored items. The scale consists of seven subscales: Support, Satisfaction, Involvement, Communication, Limit Setting, Autonomy, and Role Orientation. Higher scores indicate a more positive perceived parent-child relationship.
The Chinese version of the PCRI was translated and back-translated by bilingual professionals and reviewed by experts in occupational therapy to ensure conceptual and linguistic equivalence. It was pilot-tested with caregivers of children aged 3 to 6 to ensure clarity and cultural relevance. Internal consistency ranges from 0.59 to 0.82 across subscales, with acceptable reliability for most dimensions.
Measured: At baseline (within 1 week before the first intervention session) and immediately after completion of the 10th session (within 1 week)
Therapy Attitude Inventory - Chinese Version (TAI)
The Therapy Attitude Inventory - Chinese Version (TAI) is a 10-item self-report questionnaire designed to measure caregiver satisfaction with child-focused therapeutic interventions. Respondents rate their perceptions of treatment helpfulness and satisfaction. Higher scores means a greater sense of helpfulness and satisfaction. The TAI has demonstrated strong internal consistency (Cronbach's α = 0.91) and four-month test-retest reliability (r = 0.85).
The Chinese version of the TAI was translated and culturally adapted by the research team in previous studies. In this study, it will be administered to parents immediately following the intervention to assess overall satisfaction with the MSE-PEACE program. The questionnaire takes approximately 5 to 10 minutes to complete.
Measured: At immediately after completion of the 10th session (within 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Developmental DisabilityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling-Yi Lin, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118293
- Sponsor's protocol ID
- B-BR-113-022
- Acronym
- MSE-PEACE
- Status last verified
- Apr 2026
- First submitted
- 13 Jun 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) from this study will not be shared publicly due to the sensitive nature of the data involving young children with developmental disabilities and their families. Data privacy and confidentiality cannot be sufficiently protected for public sharing.
Publications
Zablotsky B, Black LI, Maenner MJ, Schieve LA, Danielson ML, Bitsko RH, Blumberg SJ, Kogan MD, Boyle CA. Prevalence and Trends of Developmental Disabilities among Children in the United States: 2009-2017. Pediatrics. 2019 Oct;144(4):e20190811. doi: 10.1542/peds.2019-0811.
PubMed 31558576Unwin KL, Powell G, Price A, Jones CR. Patterns of equipment use for autistic children in multi-sensory environments: Time spent with sensory equipment varies by sensory profile and intellectual ability. Autism. 2024 Mar;28(3):644-655. doi: 10.1177/13623613231180266. Epub 2023 Jul 7.
PubMed 37421130Novakovic N, Milovancevic MP, Dejanovic SD, Aleksic B. Effects of Snoezelen-Multisensory environment on CARS scale in adolescents and adults with autism spectrum disorder. Res Dev Disabil. 2019 Jun;89:51-58. doi: 10.1016/j.ridd.2019.03.007. Epub 2019 Mar 29.
PubMed 30933867DeChillo N, Koren PE, Schultze KH. From paternalism to partnership: family and professional collaboration in children's mental health. Am J Orthopsychiatry. 1994 Oct;64(4):564-76. doi: 10.1037/h0079572.
PubMed 7847572Hotz GA, Castelblanco A, Lara IM, Weiss AD, Duncan R, Kuluz JW. Snoezelen: a controlled multi-sensory stimulation therapy for children recovering from severe brain injury. Brain Inj. 2006 Jul;20(8):879-88. doi: 10.1080/02699050600832635.
PubMed 17046800Dwamena F, Holmes-Rovner M, Gaulden CM, Jorgenson S, Sadigh G, Sikorskii A, Lewin S, Smith RC, Coffey J, Olomu A. Interventions for providers to promote a patient-centred approach in clinical consultations. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD003267. doi: 10.1002/14651858.CD003267.pub2.
PubMed 23235595
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07118293
- Acronym / sponsor ID
- MSE-PEACE / B-BR-113-022
- Conditions
- Developmental Disability
- Keywords
- Developmental Disabilities, Family-Centered Intervention, Multi-Sensory Environment, Parent Empowerment, Occupational Therapy, Child Engagement, Mixed Methods
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Aug 2025 (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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSE-PEACE Group | Experimental | Behavioral: MSE-PEACEParticipants in this arm will receive the MSE-PEACE intervention, a family-centered multi-sensory environment program designed for children with developmental disabilities and their caregivers. The intervention includes 10 sessions delivered every 2 weeks, with each session lasting approximately 60 minutes. Sessions take place in a specialized sensory therapy room and are guided by certified occupational therapists. The intervention combines sensory-based activities with active parent-child co-participation. Each session is tailored to the child's sensory profile and developmental needs. Parents are engaged in goal-setting, activity participation, and follow-up support, including suggestions for home-based sensory activities and environmental adaptations. The program aims to improve children's functional engagement and emotional regulation, while enhancing caregiver empowerment, parenting competence, and family well-being. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 3 to 12 years
- Diagnosed with a developmental disability (e.g., autism spectrum disorder, attention-deficit/hyperactivity disorder, cerebral palsy, global developmental delay)
- Able to attend 10 biweekly intervention sessions in person with a caregiver
- Caregiver is the primary caregiver and agrees to actively participate in all sessions
- Caregiver is able to complete written questionnaires in Chinese
Key exclusion criteria (2 listed)
- Child has significant physical or behavioral challenges that prevent safe participation in a multi-sensory therapy setting (e.g., uncontrollable aggression, high seizure risk)
- Caregiver has cognitive or psychiatric conditions that significantly limit the ability to participate in shared sessions or complete questionnaires
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 |
|---|---|---|
| MSE-PEACEThe MSE-PEACE (Multi-Sensory Environment-Parent Empowerment and Child Engagement) intervention is a family-centered, therapist-guided sensory integration program specifically developed for children with developmental disabilities and their caregivers. Unlike traditional child-only sensory therapies, this intervention actively involves parents in all stages-assessment, goal setting, activity participation, and follow-up. Each participant dyad (parent and child) attends 10 biweekly sessions (60 minutes each) in a structured sensory therapy space equipped with adjustable lighting, tactile materials, auditory inputs, and other multisensory tools. The intervention is tailored to each child's sensory processing profile and emotional regulation needs, while promoting parent-child co-regulation, bonding, and collaborative engagement. Occupational therapists facilitate the sessions using individualized strategies to support child-led participation and empower parents with real-time coaching, | Behavioural | MSE-PEACE Group |
Primary outcome
Pediatric Volitional Questionnaire (Chinese version)
Time frame: At baseline (within 1 week before the first intervention session) and immediately after completion of the 10th session (within 1 week)
The Pediatric Volitional Questionnaire (PVQ), adapted from the Volitional Questionnaire, is used to assess a child's motivation and engagement in different environments. It consists of 14 observational items such as curiosity, task initiation, persistence, and problem solving. Each item is scored on a 4-point scale from "Passive" to "Spontaneous." The scores range from 14 to 56, higher scores mean better engagement. Observations are conducted during 15-30 minutes of free play in natural settings (e.g., therapy room, playground, or home). The PVQ has demonstrated strong reliability and validity in children with developmental delays, with an item separation reliability coefficient of 0.97. This study uses the PVQ to evaluate changes in children's volitional behavior and functional participation before and after the MSE-PEACE intervention.
Short Sensory Profile 2 - Chinese Version (SSP-2)
Time frame: At baseline (within 1 week before the first intervention session) and immediately after completion of the 10th session (within 1 week)
The Short Sensory Profile 2 (SSP-2) is a 34-item caregiver-reported questionnaire used to evaluate sensory processing patterns in children aged 3 to 14 years. It assesses four sensory quadrants: sensory seeking, sensory avoiding, sensory sensitivity, and low registration (observer). Caregivers rate each item based on the child's typical behavior in daily life using a 5-point Likert scale (1 = Almost Never to 5 = Almost Always). Higher scores within each quadrant indicate greater difficulties in sensory processing according to age norms. The Chinese version of SSP-2 has been translated and validated in prior studies, showing strong internal consistency (Cronbach's α = 0.949). This study uses the SSP-2 to assess changes in children's sensory processing patterns before and after the MSE-PEACE intervention.
Emotion Regulation Checklist - Chinese Version (ERC)
Time frame: At baseline (within 1 week before the first intervention session) and immediately after completion of the 10th session (within 1 week)
The Emotion Regulation Checklist (ERC) is a 24-item parent-report measure used to evaluate children's emotion regulation abilities. Parents rate how frequently their child demonstrates specific emotional behaviors in daily life using a 4-point Likert scale (1 = Never to 4 = Almost Always). The ERC includes two subscales: Emotion Regulation (ERC-ER), which reflects a child's ability to understand and express emotions appropriately, and Lability/Negativity (ERC-L/N), which reflects emotional dysregulation and instability. Higher ERC-ER scores indicate better emotion regulation, while higher ERC-L/N scores indicate greater emotional dysregulation. The Chinese version has shown acceptable internal consistency, with Cronbach's α values of 0.88 (ERC-ER) and 0.64 (ERC-L/N). This study uses the ERC to assess changes in children's emotional self-regulation following the MSE-PEACE intervention.
Family Empowerment Scale - Chinese Version (FES)
Time frame: At baseline (within 1 week before the first intervention session) and immediately after completion of the 10th session (within 1 week)
The Family Empowerment Scale (FES) is a 34-item self-report questionnaire designed to measure caregivers' perceptions of their empowerment when raising a child with disabilities. It evaluates empowerment across three domains: Family (12 items), Service System (12 items), and Community/Political (10 items). Respondents rate items using a 6-point Likert scale from 0 ("Not applicable") to 5 ("Very often"), with higher scores indicating higher levels of perceived empowerment. The Chinese version used in this study was translated using a forward-backward translation process, reviewed by an expert panel, and pre-tested with caregivers for clarity and cultural relevance. The original FES demonstrates strong psychometric properties, including internal consistency reliability coefficients of 0.88, 0.87, and 0.88 across the three subscales, and test-retest reliabilities of 0.83, 0.77, and 0.85, respectively.
Parenting Sense of Competence Scale - Chinese Version (PSOC)
Time frame: At baseline (within 1 week before the first intervention session) and immediately after completion of the 10th session (within 1 week)
The Parenting Sense of Competence Scale - Chinese Version (PSOC) is a 17-item self-report questionnaire used to assess parents' perceptions of their competence in the parenting role. The scale includes two subscales: (1) Parenting Efficacy (skills and knowledge) and (2) Parenting Satisfaction (comfort and value). Responses are rated on a Likert scale from 1 to 6, higher scores reflect better sense of competence that parents feel about their caregiving. The Chinese version of the PSOC has demonstrated good psychometric properties, including internal consistency (Cronbach's α = .85) and test-retest reliability (intraclass correlation coefficient = .87). It also shows construct validity through correlations with measures of self-esteem and postpartum depression. This study uses the PSOC to evaluate changes in parenting confidence and satisfaction following participation in the MSE-PEACE intervention.
Parenting Stress Index - Fourth Edition Short Form (Chinese Version) (PSI-4-SF)
Time frame: At baseline (within 1 week before the first intervention session) and immediately after completion of the 10th session (within 1 week)
The Parenting Stress Index, Fourth Edition Short Form (Chinese Version) (PSI-4-SF) is a 36-item self-report questionnaire used to assess the level and sources of stress parents experience in their caregiving role. It includes three subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. The tool helps identify whether parenting stress stems from parent characteristics, child characteristics, or the relationship between parent and child. Higher scores reflected a greater sense of stress in parenting. The Chinese version used in this study demonstrated strong psychometric properties, with internal consistency coefficients ranging from 0.92 to 0.95 across subscales and 0.97 for the total scale. Factor analysis supported the consistency of the translated scale structure with the original. This study uses the PSI-4-SF to examine changes in parenting stress levels and contributing factors before and after the MSE-PEACE.
2 secondary outcomes
Parent-Child Relationship Inventory - Chinese Version (PCRI)
Time frame: At baseline (within 1 week before the first intervention session) and immediately after completion of the 10th session (within 1 week)
Therapy Attitude Inventory - Chinese Version (TAI)
Time frame: At immediately after completion of the 10th session (within 1 week)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 31558576Zablotsky B, Black LI, Maenner MJ, Schieve LA, Danielson ML, Bitsko RH, Blumberg SJ, Kogan MD, Boyle CA. Prevalence and Trends of Developmental Disabilities among Children in the United States: 2009-2017. Pediatrics. 2019 Oct;144(4):e20190811. doi: 10.1542/peds.2019-0811.
- Background: PubMed 37421130Unwin KL, Powell G, Price A, Jones CR. Patterns of equipment use for autistic children in multi-sensory environments: Time spent with sensory equipment varies by sensory profile and intellectual ability. Autism. 2024 Mar;28(3):644-655. doi: 10.1177/13623613231180266. Epub 2023 Jul 7.
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- Individual participant dataSharing planned: No. The individual participant data (IPD) from this study will not be shared publicly due to the sensitive nature of the data involving young children with developmental disabilities and their families. Data privacy and confidentiality cannot be sufficiently protected for public sharing.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSE-PEACE in people with Developmental Disability, run by National Cheng Kung University 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 6 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 13 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Pediatric Volitional Questionnaire (Chinese version) (time frame: At baseline (within 1 week before the first intervention session) and immediately after completion of the 10th session (within 1 week)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07118293, which also lists 6 linked publications.
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 13 Apr 2026.