Clinical trial NCT03596515: Occupational Therapy With Ayres Sensory Integration Approach for School-age Children
Official title: Occupational Therapy With Ayres Sensory Integration Approach for School-age Children - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children, Only
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2018-07-24
Enrollment: 52
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction:

Sensory Integration (SI) is a theory and framework conceptualized by Dr. Jean Ayres, a highly experienced occupational therapist, with its main objective as enhancing the brain's capacity to perceive and organize sensory information to produce a more normal, adaptive response; thus, to provide the foundation for mastering academic tasks (Case-Smith and O'Brien, 2010).

Objectives:

The aim of the study is to investigate the effectiveness of ASI interventions for school-aged children with sensory modulation and sensory processing deficits.

Methodology:

A cross-clustered single-blinded randomized controlled trial was conducted in 5 occupational therapy outpatient department within Hospital Authority, to assess the difference in clinical outcomes between subjects in experimental group (received ASI) and control group (on usual waitlist for treatment). Participants in experimental group (EG) would receive 16 sessions (45 minutes each) of individualized ASI. The sessions were scheduled on weekly basis and would be completed within five months once treatment was initiated. Post-assessment outcomes would be measured at this time-point. Post-assessment outcomes would also be measured for subjects in control group (CG) at the same time-point. ASI would then be initiated for participants in CG according to usual clinical scheduling.


Eligibility criteria: Inclusion Criteria:

* aged between six and 12 years old, and attending mainstream primary school
* identified as having problems with sensory modulation and/or sensory processing, according to the Sensory Integration and Praxis Test (SIPT) and the Chinese Sensory Profile completed by their main caregivers for pre-treatment evaluation (definite differences on at least three out of seven of the factor summary or section summary)
* absence of serious emotional or behavioral disturbance
* intelligence quotient no lower than limited (scores range from limited to average or above average).

Exclusion Criteria:

* any neurological problem, such as cerebral palsy
* a history of visual and/or auditory defects or physical problems

Primary outcomes:
measure: Change on the Goal attainment scaling. Changes in functional goals were measured using goal attainment scaling in collaboration with parents and caregivers.
timeFrame: Pre and post of the treatment intervention, an average of 5 months
measure: Change on the Sensory Integration and Praxis Test scores
timeFrame: Pre and post of the treatment intervention, an average of 5 months
measure: Change on the Chinese Sensory Profile
timeFrame: Pre and post of the treatment intervention, an average of 5 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Miller LJ, Coll JR, Schoen SA. A randomized controlled pilot study of the effectiveness of occupational therapy for children with sensory modulation disorder. Am J Occup Ther. 2007 Mar-Apr;61(2):228-38. doi: 10.5014/ajot.61.2.228.
citation: Roberts JE, King-Thomas L, Boccia ML. Behavioral indexes of the efficacy of sensory integration therapy. Am J Occup Ther. 2007 Sep-Oct;61(5):555-62. doi: 10.5014/ajot.61.5.555.
citation: May-Benson TA, Koomar JA. Systematic review of the research evidence examining the effectiveness of interventions using a sensory integrative approach for children. Am J Occup Ther. 2010 May-Jun;64(3):403-14. doi: 10.5014/ajot.2010.09071.
citation: Case-Smith J, Weaver LL, Fristad MA. A systematic review of sensory processing interventions for children with autism spectrum disorders. Autism. 2015 Feb;19(2):133-48. doi: 10.1177/1362361313517762. Epub 2014 Jan 29.
citation: Candler C. Sensory integration and therapeutic riding at summer camp: occupational performance outcomes. Phys Occup Ther Pediatr. 2003;23(3):51-64.