Autism Spectrum DisorderNCT02496819
Metacognitive Self-regulated Learning and Sensory Integrative Approaches for Children With Autism Spectrum Disorders
A study testing Meta-cognitive self-regulated learning intervention, Sensory integration intervention and Activity-based intervention in people with Autism Spectrum Disorder, run by University of Western Sydney at 1 site in Malaysia.
Trial summary
Children with Autism Spectrum Disorder (ASD) are increasing each year. There are about 1 in 160 children for the age group of 6-12 years old in Australia are diagnosed with ASD. Children with ASD have impairment in two common areas including: i) social and communication and ii) repetitive and stereotypical patterns of… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Meta-cognitive self-regulated learning intervention, Sensory integration intervention and Activity-based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- Jun 2015to Mar 2017
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with ASD meeting the requirements of the Diagnostic and Statistical Manual of Mental Disorders without dual diagnoses such as physical disabilities
- Overall score ≥ 70 in Part I and Part II of the Vineland Adaptive Behaviour Scales (VABS-II) (2nd ed.). These parts of the scale will assess:.
- Problem behaviours Part I (internalizing, externalizing, other behaviours): 36 items
- Problem behaviours Part II (critical items): 14 items
- Have an IQ greater than 50. This is indicative of a normal intelligence quotient (IQ) to moderate grade intellectual disability. This is required so they are able to follow verbal instructions.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Children with Autism Spectrum Disorder (ASD) are increasing each year. There are about 1 in 160 children for the age group of 6-12 years old in Australia are diagnosed with ASD. Children with ASD have impairment in two common areas including: i) social and communication and ii) repetitive and stereotypical patterns of behaviours. These common features result in behavioural problems which negatively impact children's participation in school, activities of daily living and social engagement.
Therefore, there is a need for effective interventions to overcome the behavioural problems in children with ASD.
Read more
The purpose of the study is to investigate the effect of sensory integration (SI) and self-regulated learning versus an activity-based control programme in reducing behavioural problems in children with ASD that interfere with their daily livings, school, and social engagement.
The study will adopt a randomized controlled trial design with three intervention groups: I) self-regulated learning, II) sensory integration and III) activity-based intervention as the control group.
Read the detailed description
Children with Autism Spectrum Disorder (ASD) are commonly associated with behavioural problems which may negatively impact on their participation in school, activities of daily livings and social engagement. In order to minimise the impact on the daily functioning of these children, overcoming the behavioural problems in these children is essential.
Two intervention approaches will be used in this study. These are i) self-regulated learning and ii) sensory integration. Sensory integration is commonly used for children with developmental problems. Self-regulated learning has been used to promote children's self-directed learning and in people with brain injuries.
However, the evidence towards the effectiveness of these two interventions in alleviating the effects of behavioural problems on participation in school, daily and social activities for children with ASD is limited and inconclusive.
Self-regulated learning theory:
The origin of self-regulated learning approach came from Albert Bandura's social cognitive theory. The theory states that intervention affects one's learning by modifying the personal, environmental and behavioural factors. The personal factor refers to one's beliefs and attitudes. The environment factor comprises of feedback, instructions, information gathered from teachers or instructors and also from the assistance of parents and peers. The behavioural factor includes past performance that are socially unacceptable. The key of self-regulated learning is to ensure that children make use of a cognitive strategy to facilitate behaviour learning by helping them to bring problems and solutions towards own consciousness. Several studies had used self-regulated learning in children and adults population. It was found a significant improvement in task performance for children with Attention Deficit Hyperactive Disorders (ADHD). The positive effect was also shown in another study showing improvements in performance measures of reading and intelligence quotient among children with moderate learning disabilities. Similar results were also seen in adults with brain injury in various studies. They suggested that self-regulated learning could enhance the active learning of participants.
Children with ASD were reported to commonly associate with self-regulation problems affecting their behaviour and learning ability. However, there is no study using self-regulated learning for this group of children to alleviate the effect of behavioural problems on their school, daily and social participation.
Sensory integration intervention theory:
Sensory integration theory was developed in 1960s and 1970s. The theory was developed to target on the neurological processing of sensory information. The theory suggests that purposeful behaviours may be interrupted when there is an interference of neurological processing and integration of sensory information. Sensory integration interventions have been widely used in varieties of settings among children with development problems. However, despite the vast amount of literature that exists on the effectiveness of sensory integration intervention, the overall evidence on the effectiveness on children with ASD and behavioural problems remains inconclusive. Some studies showed that sensory integration was an effective intervention given a positive result, but others showed no benefit or inconclusive findings.
Studies previously used sensory integration intervention seemed not using the fidelity measures in the intervention design to ensure that the intervention met the requirement of sensory integration theory. This could be one of the reasons for the inconclusive finding made on its effectiveness. Furthermore, most of the studies used a single-case study design with small sample sizes. In addition, previous studies using sensory integration did not focus on alleviating the effects of behavioural problems on function in the daily livings, school and social engagement for children with ASD.
This study, will therefore, adopt a randomised controlled trial (RCT) design to investigate the effect of sensory integration and self-regulated learning interventions (comparing with activity-based control intervention) in reducing the effects of behavioural problems on daily living, school and social engagement in children with ASD.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Meta-cognitive self-regulated learning intervention, Sensory integration intervention, Activity-based intervention
- Keywords
- Children
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meta-cognitive self-regulated learning interventionOther
It is a 12-week intervention programme with one 60 minutes sessions per week.
Sensory integration interventionOther
It is a 12-week intervention programme with one 60 minutes sessions per week.
Activity-based interventionOther
It is a 12-week intervention programme with one 60 minutes sessions per week.
| Study group | Role | What they receive |
|---|---|---|
| Metacognitive self-regulated learning intervention | Experimental | It involves training of daily tasks using a self-correct strategy. Participants' performance will be video-taped and they will then watch the video playback for reflection and self-correction under the guidance of the occupational therapist. Receives: Other: Meta-cognitive self-regulated learning intervention |
| Sensory Integration intervention | Experimental | It involves active, fun physical activity completing 8 stations of activities involving tactile, proprioceptive and vestibular tasks. Frequent breaks will be given to avoid exhaustion and fatigue throughout the activities. Receives: Other: Sensory integration intervention |
| Activity-Based Intervention | Active comparator | It provides constructional, drawing and crafts activity. Participants are guided to complete these tasks Receives: Other: Activity-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adaptive behaviour on the Vineland Adaptive Behaviour Scales - change from baseline after the intervention
Measured: Baseline and after the intervention (12 weeks)
Adaptive behaviour on the Vineland Adaptive Behaviour Scales - change from baseline at one month after the intervention completed
Measured: Baseline and one month after the intervention completed (16 weeks)
Executive function behaviours on the Behaviour Rating Inventory of Executive Function - change from baseline after the intervention
Measured: Baseline and after the intervention (12 weeks)
Executive function behaviours on the Behaviour Rating Inventory of Executive Function - change from baseline at one month after the intervention completed
Measured: Baseline and one month after the intervention completed (16 weeks)
School-related task performance on the School Function Assessment - change from baseline after the intervention
Measured: Baseline and after the intervention (12 weeks)
School-related task performance on the School Function Assessment - change from baseline at one month after the intervention completed
Measured: Baseline and one month after the intervention completed (16 weeks)
Social skills on the Walker Mc-Connell scale - change from baseline after the intervention
Measured: Baseline and after the intervention (12 weeks)
Social skills on the Walker Mc-Connell scale - change from baseline at one month after the intervention completed
Measured: Baseline and one month after the intervention completed (16 weeks)
Secondary outcomes (4)
Sensory processing difficulties on the Sensory Processing Measures - change from baseline after the intervention
Measured: Baseline and after the intervention (12 weeks)
Sensory processing difficulties on the Sensory Processing Measures - change from baseline at one month after the intervention completed
Measured: Baseline and one month after the intervention completed (16 weeks)
Sensory processing patterns and effects on functional performance on the Sensory Profile - change from baseline after the intervention
Measured: Baseline and after the intervention (12 weeks)
Sensory processing patterns and effects on functional performance on the Sensory Profile - change from baseline at one month after the intervention completed
Measured: Baseline and one month after the intervention completed (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionMar 2017
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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western Sydney
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Malaysia
- Responsible party
- Principal investigator, Karen Liu, University of Western Sydney
- Investigators
- Karen P.Y. Liu, PhD, Principal investigator, Western Sydney University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496819
- Sponsor's protocol ID
- SR-Autism
- Status last verified
- Apr 2017
- First submitted
- 26 Jun 2015
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metacognitive Self-regulated Learning and Sensory Integrative Approaches for Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02496819
- Acronym / sponsor ID
- SR-Autism
- Conditions
- Autism Spectrum Disorder
- Keywords
- Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Western SydneyUniversity, hospital or other
- Collaborators
- National University of Malaysia
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 14 Jul 2015 (estimated)
- 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.
Children with Autism Spectrum Disorder (ASD) are increasing each year. There are about 1 in 160 children for the age group of 6-12 years old in Australia are diagnosed with ASD. Children with ASD have impairment in two common areas including: i) social and communication and ii) repetitive and stereotypical patterns of behaviours. These common features result in behavioural problems which negatively impact children's participation in school, activities of daily living and social engagement.
Therefore, there is a need for effective interventions to overcome the behavioural problems in children with ASD.
The purpose of the study is to investigate the effect of sensory integration (SI) and self-regulated learning versus an activity-based control programme in reducing behavioural problems in children with ASD that interfere with their daily livings, school, and social engagement.
The study will adopt a randomized controlled trial design with three intervention groups: I) self-regulated learning, II) sensory integration and III) activity-based intervention as the control group.
Detailed description
Children with Autism Spectrum Disorder (ASD) are commonly associated with behavioural problems which may negatively impact on their participation in school, activities of daily livings and social engagement. In order to minimise the impact on the daily functioning of these children, overcoming the behavioural problems in these children is essential.
Two intervention approaches will be used in this study. These are i) self-regulated learning and ii) sensory integration. Sensory integration is commonly used for children with developmental problems. Self-regulated learning has been used to promote children's self-directed learning and in people with brain injuries.
However, the evidence towards the effectiveness of these two interventions in alleviating the effects of behavioural problems on participation in school, daily and social activities for children with ASD is limited and inconclusive.
Self-regulated learning theory:
The origin of self-regulated learning approach came from Albert Bandura's social cognitive theory. The theory states that intervention affects one's learning by modifying the personal, environmental and behavioural factors. The personal factor refers to one's beliefs and attitudes. The environment factor comprises of feedback, instructions, information gathered from teachers or instructors and also from the assistance of parents and peers. The behavioural factor includes past performance that are socially unacceptable. The key of self-regulated learning is to ensure that children make use of a cognitive strategy to facilitate behaviour learning by helping them to bring problems and solutions towards own consciousness. Several studies had used self-regulated learning in children and adults population. It was found a significant improvement in task performance for children with Attention Deficit Hyperactive Disorders (ADHD). The positive effect was also shown in another study showing improvements in performance measures of reading and intelligence quotient among children with moderate learning disabilities. Similar results were also seen in adults with brain injury in various studies. They suggested that self-regulated learning could enhance the active learning of participants.
Children with ASD were reported to commonly associate with self-regulation problems affecting their behaviour and learning ability. However, there is no study using self-regulated learning for this group of children to alleviate the effect of behavioural problems on their school, daily and social participation.
Sensory integration intervention theory:
Sensory integration theory was developed in 1960s and 1970s. The theory was developed to target on the neurological processing of sensory information. The theory suggests that purposeful behaviours may be interrupted when there is an interference of neurological processing and integration of sensory information. Sensory integration interventions have been widely used in varieties of settings among children with development problems. However, despite the vast amount of literature that exists on the effectiveness of sensory integration intervention, the overall evidence on the effectiveness on children with ASD and behavioural problems remains inconclusive. Some studies showed that sensory integration was an effective intervention given a positive result, but others showed no benefit or inconclusive findings.
Studies previously used sensory integration intervention seemed not using the fidelity measures in the intervention design to ensure that the intervention met the requirement of sensory integration theory. This could be one of the reasons for the inconclusive finding made on its effectiveness. Furthermore, most of the studies used a single-case study design with small sample sizes. In addition, previous studies using sensory integration did not focus on alleviating the effects of behavioural problems on function in the daily livings, school and social engagement for children with ASD.
This study, will therefore, adopt a randomised controlled trial (RCT) design to investigate the effect of sensory integration and self-regulated learning interventions (comparing with activity-based control intervention) in reducing the effects of behavioural problems on daily living, school and social engagement in children with ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metacognitive self-regulated learning intervention | Experimental | Other: Meta-cognitive self-regulated learning interventionIt involves training of daily tasks using a self-correct strategy. Participants' performance will be video-taped and they will then watch the video playback for reflection and self-correction under the guidance of the occupational therapist. |
| Sensory Integration intervention | Experimental | Other: Sensory integration interventionIt involves active, fun physical activity completing 8 stations of activities involving tactile, proprioceptive and vestibular tasks. Frequent breaks will be given to avoid exhaustion and fatigue throughout the activities. |
| Activity-Based Intervention | Active comparator | Other: Activity-based interventionIt provides constructional, drawing and crafts activity. Participants are guided to complete these tasks |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosed with ASD meeting the requirements of the Diagnostic and Statistical Manual of Mental Disorders without dual diagnoses such as physical disabilities
- Overall score ≥ 70 in Part I and Part II of the Vineland Adaptive Behaviour Scales (VABS-II) (2nd ed.). These parts of the scale will assess:.
- Have an IQ greater than 50. This is indicative of a normal intelligence quotient (IQ) to moderate grade intellectual disability. This is required so they are able to follow verbal instructions.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Meta-cognitive self-regulated learning interventionIt is a 12-week intervention programme with one 60 minutes sessions per week. | Other | Metacognitive self-regulated learning intervention |
| Sensory integration interventionIt is a 12-week intervention programme with one 60 minutes sessions per week. | Other | Sensory Integration intervention |
| Activity-based interventionIt is a 12-week intervention programme with one 60 minutes sessions per week. | Other | Activity-Based Intervention |
Primary outcome
Adaptive behaviour on the Vineland Adaptive Behaviour Scales - change from baseline after the intervention
Time frame: Baseline and after the intervention (12 weeks)
Adaptive behaviour on the Vineland Adaptive Behaviour Scales - change from baseline at one month after the intervention completed
Time frame: Baseline and one month after the intervention completed (16 weeks)
Executive function behaviours on the Behaviour Rating Inventory of Executive Function - change from baseline after the intervention
Time frame: Baseline and after the intervention (12 weeks)
Executive function behaviours on the Behaviour Rating Inventory of Executive Function - change from baseline at one month after the intervention completed
Time frame: Baseline and one month after the intervention completed (16 weeks)
School-related task performance on the School Function Assessment - change from baseline after the intervention
Time frame: Baseline and after the intervention (12 weeks)
School-related task performance on the School Function Assessment - change from baseline at one month after the intervention completed
Time frame: Baseline and one month after the intervention completed (16 weeks)
Social skills on the Walker Mc-Connell scale - change from baseline after the intervention
Time frame: Baseline and after the intervention (12 weeks)
Social skills on the Walker Mc-Connell scale - change from baseline at one month after the intervention completed
Time frame: Baseline and one month after the intervention completed (16 weeks)
4 secondary outcomes
Sensory processing difficulties on the Sensory Processing Measures - change from baseline after the intervention
Time frame: Baseline and after the intervention (12 weeks)
Sensory processing difficulties on the Sensory Processing Measures - change from baseline at one month after the intervention completed
Time frame: Baseline and one month after the intervention completed (16 weeks)
Sensory processing patterns and effects on functional performance on the Sensory Profile - change from baseline after the intervention
Time frame: Baseline and after the intervention (12 weeks)
Sensory processing patterns and effects on functional performance on the Sensory Profile - change from baseline at one month after the intervention completed
Time frame: Baseline and one month after the intervention completed (16 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- 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.
Karen P.Y. Liu, PhD principal investigator
Western Sydney University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meta-cognitive self-regulated learning intervention, Sensory integration intervention and Activity-based intervention in people with Autism Spectrum Disorder, run by University of Western Sydney 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 5 inclusion and 0 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: finished, as of the sponsor's last update on 6 Nov 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adaptive behaviour on the Vineland Adaptive Behaviour Scales - change from baseline after the intervention (time frame: Baseline and after the intervention (12 weeks)). The study lists 8 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 6 Nov 2017.