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

Overview

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.

Interventions

• 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 m

Primary outcome measures

• 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)]
• 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)]
• 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)]
• 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)]
• 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)]
• 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)]

Secondary outcome measures (2)

• 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

Taiwan · 1 center

• Department of Occupational Therapy, National Cheng Kung University — Tainan

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. PMID 31558576
• Unwin 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. PMID 37421130
• Novakovic 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. PMID 30933867
• DeChillo 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. PMID 7847572
• Hotz 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. PMID 17046800
• Dwamena 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. PMID 23235595

Identifiers

NCT: NCT07118293 · B-BR-113-022

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗