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

National Cheng Kung University

Status: Not yet enrolling

Conditions: Developmental Disability

Treatments: Behavioral: MSE-PEACE

Study type: Interventional

Funder types: Other

Identifiers

NCT07118293

B-BR-113-022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

MSE-PEACE Group

Experimental group

Description:

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.

Treatment:

Behavioral: MSE-PEACE