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Metacognitive Self-regulated Learning and Sensory Integrative Approaches for Children With Autism Spectrum Disorders

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Meta-cognitive self-regulated learning intervention
Sensory integration intervention
Activity-based intervention
Sponsored by
University of Western Sydney
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Children

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Sites / Locations

  • National University of Malaysia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Metacognitive self-regulated learning intervention

Sensory Integration intervention

Activity-Based Intervention

Arm Description

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.

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.

It provides constructional, drawing and crafts activity. Participants are guided to complete these tasks

Outcomes

Primary Outcome Measures

Adaptive behaviour on the Vineland Adaptive Behaviour Scales - change from baseline after the intervention
Adaptive behaviour on the Vineland Adaptive Behaviour Scales - change from baseline at one month after the intervention completed
Executive function behaviours on the Behaviour Rating Inventory of Executive Function - change from baseline after the intervention
Executive function behaviours on the Behaviour Rating Inventory of Executive Function - change from baseline at one month after the intervention completed
School-related task performance on the School Function Assessment - change from baseline after the intervention
School-related task performance on the School Function Assessment - change from baseline at one month after the intervention completed
Social skills on the Walker Mc-Connell scale - change from baseline after the intervention
Social skills on the Walker Mc-Connell scale - change from baseline at one month after the intervention completed

Secondary Outcome Measures

Sensory processing difficulties on the Sensory Processing Measures - change from baseline after the intervention
Sensory processing difficulties on the Sensory Processing Measures - change from baseline at one month after the intervention completed
Sensory processing patterns and effects on functional performance on the Sensory Profile - change from baseline after the intervention
Sensory processing patterns and effects on functional performance on the Sensory Profile - change from baseline at one month after the intervention completed

Full Information

First Posted
June 26, 2015
Last Updated
November 2, 2017
Sponsor
University of Western Sydney
Collaborators
National University of Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT02496819
Brief Title
Metacognitive Self-regulated Learning and Sensory Integrative Approaches for Children With Autism Spectrum Disorders
Official Title
Metacognitive Self-regulated Learning and Sensory Integrative Approaches for Children With Autism Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Western Sydney
Collaborators
National University of Malaysia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metacognitive self-regulated learning intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Sensory Integration intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Activity-Based Intervention
Arm Type
Active Comparator
Arm Description
It provides constructional, drawing and crafts activity. Participants are guided to complete these tasks
Intervention Type
Other
Intervention Name(s)
Meta-cognitive self-regulated learning intervention
Intervention Description
It is a 12-week intervention programme with one 60 minutes sessions per week.
Intervention Type
Other
Intervention Name(s)
Sensory integration intervention
Intervention Description
It is a 12-week intervention programme with one 60 minutes sessions per week.
Intervention Type
Other
Intervention Name(s)
Activity-based intervention
Intervention Description
It is a 12-week intervention programme with one 60 minutes sessions per week.
Primary Outcome Measure Information:
Title
Adaptive behaviour on the Vineland Adaptive Behaviour Scales - change from baseline after the intervention
Time Frame
Baseline and after the intervention (12 weeks)
Title
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)
Title
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)
Title
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)
Title
School-related task performance on the School Function Assessment - change from baseline after the intervention
Time Frame
Baseline and after the intervention (12 weeks)
Title
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)
Title
Social skills on the Walker Mc-Connell scale - change from baseline after the intervention
Time Frame
Baseline and after the intervention (12 weeks)
Title
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)
Secondary Outcome Measure Information:
Title
Sensory processing difficulties on the Sensory Processing Measures - change from baseline after the intervention
Time Frame
Baseline and after the intervention (12 weeks)
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen P.Y. Liu, PhD
Organizational Affiliation
Western Sydney University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University of Malaysia
City
Bangi
State/Province
Selango
ZIP/Postal Code
43600
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No

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Metacognitive Self-regulated Learning and Sensory Integrative Approaches for Children With Autism Spectrum Disorders

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