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

NCT ID: NCT07118293

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Developmental Disability

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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MSE-PEACE Group

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.

Group Type EXPERIMENTAL

MSE-PEACE

Intervention Type BEHAVIORAL

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,

Interventions

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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,

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cheng Kung University

OTHER

Sponsor Role lead

Responsible Party

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Ling-Yi Lin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Occupational Therapy, National Cheng Kung University

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Ling-Yi Lin/ Professor, Doctor of Science

Role: CONTACT

+886-6-2353535 ext. 5917

References

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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.

Reference Type BACKGROUND
PMID: 31558576 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37421130 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30933867 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7847572 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17046800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23235595 (View on PubMed)

Other Identifiers

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B-BR-113-022

Identifier Type: -

Identifier Source: org_study_id

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