Clinical trial NCT06209749: Keberkesanan Modul Intervensi Berasaskan Sensori Dalam Kalangan Kanak-kanak Dengan Autisme/The Effectiveness of Sensory-based Intervention in Children With Autism Spectrum Disorders.
Official title: Pembangunan Dan Keberkesanan Modul Intervensi Berasaskan Sensori Dalam Kalangan Kanak-kanak Dengan Autisme / The Development and Effectiveness of Sensory-based Intervention Modules in Children With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Sensory-based intervention
Social skills
Play
Children
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
Collaborators: name: Ministry of Education, Malaysia
First posted: 2024-01-17
Enrollment: 32
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: TREATMENT

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.

Detailed description: The proposed research design for this study is a quantitative approach using a Randomized Controlled Trial (RCT) method. This design randomly assigns participants to either an experimental or a control group, utilizing an application for allocation. The study includes pre-tests, post-tests and follow-ups to measure dependent variables such as sensory processing, social skills, and play.

For sampling, the study will be conducted at Pusat PERMATA Kurnia, a school and research centre specialized for children with Autism Spectrum Disorder (ASD). The participants will be children with ASD, aged 4-6 years, attending learning sessions at Pusat PERMATA Kurnia. The sampling method used is simple random sampling using the Research Randomizer application on the internet. This double-blind study involves occupational therapists who meet the criteria and will be informed about the study without knowing the group allocation.

The sample size is calculated based on phase 3 study objectives using G power software, considering an alpha level of 0.05 and a power of 0.8. As per the calculations, the total sample size for this effectiveness study is 32 participants, accounting for the largest dependent variable size in both intervention and control groups.

The inclusion criteria for the sample are children with ASD:

i. whose diagnosis of ASD is confirmed by a Medical Officer) ii. aged 4-6 years, and iii. experiencing sensory processing disorders (seeking, hypersensitive and under responsiveness) as screened using Sensory Profile 2.

The exclusion criteria for the sample are children with ASD:

i. Attend any other occupational therapy intervention at Pusat PERMATA Kurnia or outside ii. Have chronic medical problems such as heart problems or asthma

Data collection involves screening and procedure steps. Researchers will screen for potential participants based on inclusion and exclusion criteria. Two occupational therapists who are Malaysian citizens and have experience managing children with ASD will be appointed for the intervention. One occupational therapist who was not doing intervention was assigned as an assessor in assessments which is double-blind to the study groups. The intervention group will receive a Sensory-based intervention module and usual school activities thrice a week for 12 weeks duration. The control group will receive school activities learning four times a week for 12 weeks without the SBI module. Post-tests will be conducted after the intervention period and follow-up test after 30 days.

Eligibility criteria: Inclusion Criteria:

1. Occupational Therapist

   a. Implements SBI intervention
2. Children with ASD

   1. A Medical Officer confirms the diagnosis of ASD
   2. Aged 4-6 years
   3. Experiencing a sensory processing disorder
   4. Get the usual school activities

Exclusion Criteria:

1. Occupational Therapist

   a. Non-citizen
2. Children with ASD

   1. Attend any other occupational therapy intervention at Pusat PERMATA Kurnia or outside
   2. Have chronic medical problems such as heart problems or asthma

Primary outcomes:
measure: 32 participants will assess sensory processing using Sensory Profile 2
timeFrame: 1st week (Pre-test), 14th week (Post-test) and 18th week (Follow up)
measure: 32 participants will assess sensory processing using Sensory Processing Measurement 2 (SPM-2)
timeFrame: 1st week (Pre-test), 14th week (Post-test) and 18th week (Follow up)
measure: 32 participants will assess social skills using Social Responsiveness Scale 2 (SRS-2)
timeFrame: 1st week (Pre-test), 14th week (Post-test) and 18th week (Follow up)
measure: 32 participants will assess play skills using Knox Preschool Play Scale
timeFrame: 1st week (Pre-test), 14th week (Post-test)
Secondary outcomes:
Other outcomes:
Locations:
city: Sentul
country: Malaysia
facility: Pusat PERMATA Kurnia
state: Kuala Lumpur
Study officials:
References: