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

NCT02496819 | Completed

• 1 other identifier: SR-Autism
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Children

Outcome Measures

Primary Outcomes (8)

• Adaptive behaviour on the Vineland Adaptive Behaviour Scales - change from baseline after the intervention

  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

  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

  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

  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

  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

  Baseline and one month after the intervention completed (16 weeks)

• Social skills on the Walker Mc-Connell scale - change from baseline after the intervention

  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

  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

  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

  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

  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

  Baseline and one month after the intervention completed (16 weeks)

Study Arms (3)

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.

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.

Other: Sensory integration intervention

Activity-Based Intervention

ACTIVE COMPARATOR

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

Other: Activity-based intervention

Interventions

Meta-cognitive self-regulated learning intervention OTHER

It is a 12-week intervention programme with one 60 minutes sessions per week.

Metacognitive self-regulated learning intervention

Sensory integration intervention OTHER

It is a 12-week intervention programme with one 60 minutes sessions per week.

Sensory Integration intervention

Activity-based intervention OTHER

It is a 12-week intervention programme with one 60 minutes sessions per week.

Activity-Based Intervention

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Western Sydney: lead
• National University of Malaysia: collaborator

Study Sites (1)

National University of Malaysia

Bangi, Selango, 43600, Malaysia

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Karen P.Y. Liu, PhD

  Western Sydney University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 14, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)