Autism Spectrum DisorderNCT06209749
Keberkesanan Modul Intervensi Berasaskan Sensori Dalam Kalangan Kanak-kanak Dengan Autisme/The Effectiveness of Sensory-based Intervention in Children With Autism Spectrum Disorders.
A study testing Sensory-based intervention module in people with Autism Spectrum Disorder, run by National University of Malaysia at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Sensory-based intervention module
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteMalaysia
- Study dates
- 29 Jan 2024to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Occupational Therapist
- 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
Who cannot join
- Occupational Therapist
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- 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:
- 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Sensory-based intervention module
- Keywords
- Sensory-based intervention, Social skills, Play, Children
- Medical subject headings
- Autism Spectrum Disorder, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory-based intervention moduleOther
Consists of sensory-based activities (Set A-F) with six weeks of individual sessions and six weeks of group sessions
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 1st week (Pre-test), 14th week (Post-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start29 Jan 2024
- Primary completionMay 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Malaysia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209749
- Sponsor's protocol ID
- JEP-2022-576
- Status last verified
- Mar 2024
- First submitted
- 7 Dec 2023
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06209749
- Acronym / sponsor ID
- JEP-2022-576
- Conditions
- Autism Spectrum Disorder
- Keywords
- Sensory-based intervention, Social skills, Play, Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- Ministry of Education, Malaysia
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Sensory-based intervention moduleSensory-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) |
| Control group | No intervention | –Usual school activities will be given four days a week for 12 weeks (6 hours per day) |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Occupational Therapist
- Children with ASD
Key exclusion criteria (5 listed)
- Occupational Therapist
- Children with ASD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory-based intervention moduleConsists of sensory-based activities (Set A-F) with six weeks of individual sessions and six weeks of group sessions | Other | Intervention group |
Primary outcome
32 participants will assess sensory processing using Sensory Profile 2
Time frame: 1st week (Pre-test), 14th week (Post-test) and 18th week (Follow up)
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
32 participants will assess sensory processing using Sensory Processing Measurement 2 (SPM-2)
Time frame: 1st week (Pre-test), 14th week (Post-test) and 18th week (Follow up)
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.
32 participants will assess social skills using Social Responsiveness Scale 2 (SRS-2)
Time frame: 1st week (Pre-test), 14th week (Post-test) and 18th week (Follow up)
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
32 participants will assess play skills using Knox Preschool Play Scale
Time frame: 1st week (Pre-test), 14th week (Post-test)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory-based intervention module in people with Autism Spectrum Disorder, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
32 participants will assess sensory processing using Sensory Profile 2 (time frame: 1st week (Pre-test), 14th week (Post-test) and 18th week (Follow up)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.