Keberkesanan Modul Intervensi Berasaskan Sensori Dalam Kalangan Kanak-kanak Dengan Autisme/The Effectiveness of Sensory-based Intervention in Children With Autism Spectrum Disorders.

NCT06209749 | Enrolling By Invitation DMC

• 1 other identifier: JEP-2022-576
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to investigate the effectiveness of Sensory-based intervention modules on children with Autism Spectrum Disorder (ASD). The main questions this study aims to answer is How do children with ASD respond to Sensory-based intervention (SBI) in terms of their sensory processing, social skills, and play? Thus, the objective of this study is to determine the significant differences in sensory processing, social skills, and play in children with ASD before and after receiving the Sensory-based intervention (SBI) module in the intervention and control groups. Participants in this study are children with ASD, aged between 4-6 years, who attend Pusat PERMATA Kurnia, a specialized school for ASD. The children will undergo assessments using the Sensory Profile 2 and Sensory Processing Measurement 2 for sensory processing, the Social Responsiveness Scale for social skills, and Knox Preschool Play Scale to measure play. Researchers will compare two groups: one receiving Sensory-Based Interventions (SBI) modules with usual school activities (intervention group), and the other receiving only usual school activities (control group). We aim to see if the SBI module makes a significant difference in sensory processing, social skills, and play in children with ASD.

Conditions

Autism Spectrum Disorder

Keywords

Sensory-based intervention; Social skills; Play; Children

Outcome Measures

Primary Outcomes (4)

• 32 participants will assess sensory processing using Sensory Profile 2

  The Sensory Profile™ 2 family of assessments provides standardized tools to help evaluate a child's sensory processing patterns in the context of home, school, and community-based activities. Parents or caregivers are assessing this form. This form can be used from newborn until 14:11 years. This form consists of 86 Likert-type items rated in terms of the frequency of a specific behaviour (0=Does do not apply, 1=Almost never, 2=Occasionally, 3=Half of the time, 4=Frequently, 5=Almost always) and require about 15-20 minutes to complete. Test-retest :0.83-0.97, Inter-rater: 0.70-0.90, Internal consistency 0.57-0.93

  1st week (Pre-test), 14th week (Post-test) and 18th week (Follow up)

• 32 participants will assess sensory processing using Sensory Processing Measurement 2 (SPM-2)

  SPM-2 forms are designed to assess sensory functioning, praxis, and social participation across the lifespan, with unique forms in each of the five age levels. In this study, we used Child SPM-2 (5-12 years). This form consists of a Home form (Completed by parents or another caregiver) and a School Form (completed by the child's primary classroom teacher or aide). This form consists of 80 Likert-type items rated regarding the frequency of a specific behaviour (1=Never,2= Occasionally, 3=Frequently, 4=Always). It requires about 20 to 30 minutes to complete-higher scores representing more problematic behavior. Evidence supporting reliability included median estimates of internal consistency of 0.86, test-retest reliability of 0.84, alternate-forms reliability of 0.78, and interrater reliability of 0.66.

  1st week (Pre-test), 14th week (Post-test) and 18th week (Follow up)

• 32 participants will assess social skills using Social Responsiveness Scale 2 (SRS-2)

  SRS-2 is a 65-item Likert scale with the objective measure of symptoms associated with autism-related components of social impairment. This form allows ratings to be collected on individuals across the age span from 2.5 years through adulthood. This study used the School Age (ages 4 to 18 years) rate by parents and teachers. Raters can complete the 65 items in 15-20 minutes. Scoring (1=not true, 2=sometimes true, 3=often true, 4=almost always true) with higher scores represents more social impairment in autistic children. Test-retest: 0.83-0.97, Inter-rater 0.72-0.91, Internal consistency 0.95

  1st week (Pre-test), 14th week (Post-test) and 18th week (Follow up)

• 32 participants will assess play skills using Knox Preschool Play Scale

  Knox Preschool Play Scale is an observational assessment designed to give a developmental description of typical play behavior from birth through the age of 6 years. The items are grouped into four dimensions. Reviewing existing developmental and play scales determined the behavior descriptions under each dimension. The observation is in the range of 30-60 minutes. Within the factors, the observer places a mark above each descriptor each time it is observed. Then, the factor is ranked at the highest level unless the descriptor is insignificant. Scoring ( 0-6 months, 6-12 months, 12-18 months, 18-24 months, 24-30 months, 30-36 months, 36-48 months, 48-60 months, 60-72 months). Each factor is scored at the upper age of the age grouping. To achieve each dimension, the observer takes the mean of the factor scores. To cut an overall play age, the observer takes the mean of the dimension scores. Test-retest: 0.86-0.96, Inter-rater 0.89-0.98, Internal consistency 0.95.

  1st week (Pre-test), 14th week (Post-test)

Study Arms (2)

Intervention group

EXPERIMENTAL

Sensory-based intervention module will be given for three sessions a week for 12 weeks (30 minutes per session). Usual school activities will be given four days a week for 12 weeks (6 hours per day)

Other: Sensory-based intervention module

Control group

NO INTERVENTION

Usual school activities will be given four days a week for 12 weeks (6 hours per day)

Interventions

Sensory-based intervention module OTHER

Consists of sensory-based activities (Set A-F) with six weeks of individual sessions and six weeks of group sessions

Intervention group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Occupational Therapist
• a. Implements SBI intervention
• Children with ASD
• A Medical Officer confirms the diagnosis of ASD
• Aged 4-6 years
• Experiencing a sensory processing disorder
• Get the usual school activities

You may not qualify if:

• Occupational Therapist
• a. Non-citizen
• Children with ASD
• Attend any other occupational therapy intervention at Pusat PERMATA Kurnia or outside
• Have chronic medical problems such as heart problems or asthma

Sponsors & Collaborators

• National University of Malaysia: lead
• Ministry of Education, Malaysia: collaborator

Study Sites (1)

Pusat PERMATA Kurnia

Sentul, Kuala Lumpur, 51000, Malaysia

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Social Skills

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 17, 2024
• Study Start: January 29, 2024
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)