Autism Spectrum Disorder Clinical Trial
Official title:
Metacognitive Self-regulated Learning and Sensory Integrative Approaches for Children With Autism Spectrum Disorders
Verified date | April 2017 |
Source | University of Western Sydney |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Malaysia | National University of Malaysia | Bangi | Selango |
Lead Sponsor | Collaborator |
---|---|
University of Western Sydney | National University of Malaysia |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adaptive behaviour on the Vineland Adaptive Behaviour Scales - change from baseline after the intervention | Baseline and after the intervention (12 weeks) | ||
Primary | Adaptive behaviour on the Vineland Adaptive Behaviour Scales - change from baseline at one month after the intervention completed | Baseline and one month after the intervention completed (16 weeks) | ||
Primary | Executive function behaviours on the Behaviour Rating Inventory of Executive Function - change from baseline after the intervention | Baseline and after the intervention (12 weeks) | ||
Primary | Executive function behaviours on the Behaviour Rating Inventory of Executive Function - change from baseline at one month after the intervention completed | Baseline and one month after the intervention completed (16 weeks) | ||
Primary | School-related task performance on the School Function Assessment - change from baseline after the intervention | Baseline and after the intervention (12 weeks) | ||
Primary | School-related task performance on the School Function Assessment - change from baseline at one month after the intervention completed | Baseline and one month after the intervention completed (16 weeks) | ||
Primary | Social skills on the Walker Mc-Connell scale - change from baseline after the intervention | Baseline and after the intervention (12 weeks) | ||
Primary | Social skills on the Walker Mc-Connell scale - change from baseline at one month after the intervention completed | Baseline and one month after the intervention completed (16 weeks) | ||
Secondary | Sensory processing difficulties on the Sensory Processing Measures - change from baseline after the intervention | Baseline and after the intervention (12 weeks) | ||
Secondary | Sensory processing difficulties on the Sensory Processing Measures - change from baseline at one month after the intervention completed | Baseline and one month after the intervention completed (16 weeks) | ||
Secondary | Sensory processing patterns and effects on functional performance on the Sensory Profile - change from baseline after the intervention | Baseline and after the intervention (12 weeks) | ||
Secondary | Sensory processing patterns and effects on functional performance on the Sensory Profile - change from baseline at one month after the intervention completed | Baseline and one month after the intervention completed (16 weeks) |
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