An interventional study of MSE-PEACE in Developmental Disability, sponsored by National Cheng Kung University. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 3 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by National Cheng Kung University · Not applicable, Interventional, and Supportive care
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.
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.
230 studies on the registry are indexed under Developmental Disabilities; 65 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 150 interventional studies indexed under Developmental Disabilities.
Browse Developmental Disabilities studies →National Cheng Kung University is the lead sponsor of 63 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: MSE-PEACE
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,
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline (within 1 week before the first intervention session) and immediately after completion of the 10th session (within 1 week)
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.
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)
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.
Time frame: At immediately after completion of the 10th session (within 1 week)
Plan to share: 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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