By InvitationNot Applicable

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

Taiwan30 participantsStarted 2025-09-01

Plain-language 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.

Who can participate

Age range3 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Pediatric Volitional Questionnaire (Chinese version)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: At baseline (within 1 week before the first intervention session) and immediately after completion of the 10th session (within 1 week)

Trial details

NCT IDNCT07118293

SponsorNational Cheng Kung University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Developmental Disability trials

Plain-language summary

Who can participate

Age range3 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Pediatric Volitional Questionnaire (Chinese version)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: At baseline (within 1 week before the first intervention session) and immediately after completion of the 10th session (within 1 week)