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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Pediatric Volitional Questionnaire (Chinese version) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: At baseline (within 1 week before the first intervention session) and immediately after completion of the 10th session (within 1 week)]

Вторичные конечные точки (2)

• Parent-Child Relationship Inventory - Chinese Version (PCRI) [Срок оценки: 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) [Срок оценки: At immediately after completion of the 10th session (within 1 week)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Тайвань · 1 центр

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

Публикации

• 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

Идентификаторы

NCT: NCT07118293 · B-BR-113-022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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