Children, OnlyNCT03596515
Occupational Therapy With Ayres Sensory Integration Approach for School-age Children
A study testing Sensory Integration in people with Children, Only, run by Hospital Authority, Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Children, Only
- What is being tested?
- Sensory Integration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2014to Dec 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
- 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).
Who cannot join
- any neurological problem, such as cerebral palsy
- a history of visual and/or auditory defects or physical problems
About this study
Official title: Occupational Therapy With Ayres Sensory Integration Approach for School-age Children - a Randomized Controlled Trial
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).
Read more
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.
- Conditions
- Children, Only
- Being tested
- Sensory Integration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory IntegrationOther
Also called Ayres Sensory Integration Approach
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.
| Study group | Role | What they receive |
|---|---|---|
| Received sensory integration therapy | Experimental | Participants in the experimental group received 16 sessions (45 minutes each) of individualized Ayres Sensory Integration intervention. Receives: Other: Sensory Integration |
| Waitlist control group | No intervention | Participants in the control group received Ayres Sensory Integration according to the usual clinical scheduling. It is after the post- assessment outcome at the same time of the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on the Goal attainment scaling. Changes in functional goals were measured using goal attainment scaling in collaboration with parents and caregivers.
Goal attainment scaling (GAS) is the full name of this scale. It is an individualized, criterion-referenced measures of changes. In involves defining a set of unique goals for a client, and then specifying a range of outcomes, which reflect concrete activities. It is a goal-setting process determining intervention outcomes expressly relevant to individuals and their families. It can show functional and meaningful outcomes that are often challenging to assess using standardized measures. It is a 5-point rating scale ranging from -2 to +2 (-2 is the least favorable treatment outcome, 0 is the predicted expected level of performance, and +2 is the most favorable treatment outcome). In this study, three individualized goals were developed for each participant by occupational therapists in conjunction with the parents or caregivers. The occupational therapists transferred the score of each child in each goal in the pre- and post-assessments according to parents' ratings.
Measured: Pre and post of the treatment intervention, an average of 5 months
Change on the Sensory Integration and Praxis Test scores
Sensory Integration and Praxis Test (SIPT) is the full name of this scale. This is a standardized test for assessing the sensory integration and praxis of children between the ages of four years and eight years, eleven months. This study used six subtests of the SIPT - standing and walking balance, postural praxis, post-rotary nystagmus, motor accuracy, sequencing praxis, and graphesthesia - based on expert opinions. SIPT offers is computer scoring and interpretation. Therapists simply record the child's performance and enter into the software. The software will generates the S.D. scores and percentile scores. Average SD scores are usually considered to fall between -1 to +1. Scores below -2 generally indicate definite problems, while scores between -2 and -1 are indicative of possible problems.
Measured: Pre and post of the treatment intervention, an average of 5 months
Change on the Chinese Sensory Profile
Chinese Sensory Profile is the full name of this scale.This is a judgment-based questionnaire answered on a 5-point Likert scale. It is regarded as a standardized assessment for screening the sensory processing abilities of children between the ages of three and 12 years. Score each response according to the following criteria:1. Always = 1 point; 2. Frequently = 2 points; 3. Occassionally = 3 points; 4. Seldom = 4 points; 5. Never = 5 points.To determine the section raw score total, add the item scores for each section and transfer the total to the section summary table. Plot the child's section raw score totals in the classification column corresponding to the raw score total for each section.Cut scores were determined for each section in the following manner: 1. Typical performance includes scores at or above 1 S.D. below the mean; 2. Probable difference is includes scores at or above 2 S.D. below the mean; 3. Definite difference is includes scores below 2 S.D. below the mean.
Measured: Pre and post of the treatment intervention, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start10 Apr 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Children, OnlyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Phoebe Chan, Hospital Authority, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596515
- Sponsor's protocol ID
- KC/KE-13-0135/FR-3
- Status last verified
- Jul 2018
- First submitted
- 2 Jul 2018
- Last updated
- 30 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 17436845Roberts 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.
PubMed 17944293May-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.
PubMed 20608272Case-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.
PubMed 24477447Candler C. Sensory integration and therapeutic riding at summer camp: occupational performance outcomes. Phys Occup Ther Pediatr. 2003;23(3):51-64.
PubMed 14664311
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Therapy With Ayres Sensory Integration Approach for School-age Children - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03596515
- Acronym / sponsor ID
- KC/KE-13-0135/FR-3
- Conditions
- Children, Only
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- 10 Apr 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 24 Jul 2018 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Received sensory integration therapy | Experimental | Other: Sensory IntegrationParticipants in the experimental group received 16 sessions (45 minutes each) of individualized Ayres Sensory Integration intervention. |
| Waitlist control group | No intervention | –Participants in the control group received Ayres Sensory Integration according to the usual clinical scheduling. It is after the post- assessment outcome at the same time of the experimental group. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- any neurological problem, such as cerebral palsy
- a history of visual and/or auditory defects or physical problems
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 |
|---|---|---|
| Sensory IntegrationAlso: Ayres Sensory Integration ApproachSensory 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. | Other | Received sensory integration therapy |
Primary outcome
Change on the Goal attainment scaling. Changes in functional goals were measured using goal attainment scaling in collaboration with parents and caregivers.
Time frame: Pre and post of the treatment intervention, an average of 5 months
Goal attainment scaling (GAS) is the full name of this scale. It is an individualized, criterion-referenced measures of changes. In involves defining a set of unique goals for a client, and then specifying a range of outcomes, which reflect concrete activities. It is a goal-setting process determining intervention outcomes expressly relevant to individuals and their families. It can show functional and meaningful outcomes that are often challenging to assess using standardized measures. It is a 5-point rating scale ranging from -2 to +2 (-2 is the least favorable treatment outcome, 0 is the predicted expected level of performance, and +2 is the most favorable treatment outcome). In this study, three individualized goals were developed for each participant by occupational therapists in conjunction with the parents or caregivers. The occupational therapists transferred the score of each child in each goal in the pre- and post-assessments according to parents' ratings.
Change on the Sensory Integration and Praxis Test scores
Time frame: Pre and post of the treatment intervention, an average of 5 months
Sensory Integration and Praxis Test (SIPT) is the full name of this scale. This is a standardized test for assessing the sensory integration and praxis of children between the ages of four years and eight years, eleven months. This study used six subtests of the SIPT - standing and walking balance, postural praxis, post-rotary nystagmus, motor accuracy, sequencing praxis, and graphesthesia - based on expert opinions. SIPT offers is computer scoring and interpretation. Therapists simply record the child's performance and enter into the software. The software will generates the S.D. scores and percentile scores. Average SD scores are usually considered to fall between -1 to +1. Scores below -2 generally indicate definite problems, while scores between -2 and -1 are indicative of possible problems.
Change on the Chinese Sensory Profile
Time frame: Pre and post of the treatment intervention, an average of 5 months
Chinese Sensory Profile is the full name of this scale.This is a judgment-based questionnaire answered on a 5-point Likert scale. It is regarded as a standardized assessment for screening the sensory processing abilities of children between the ages of three and 12 years. Score each response according to the following criteria:1. Always = 1 point; 2. Frequently = 2 points; 3. Occassionally = 3 points; 4. Seldom = 4 points; 5. Never = 5 points.To determine the section raw score total, add the item scores for each section and transfer the total to the section summary table. Plot the child's section raw score totals in the classification column corresponding to the raw score total for each section.Cut scores were determined for each section in the following manner: 1. Typical performance includes scores at or above 1 S.D. below the mean; 2. Probable difference is includes scores at or above 2 S.D. below the mean; 3. Definite difference is includes scores below 2 S.D. below the mean.
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 30 Jul 2018.
- Background: PubMed 17436845Miller 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.
- Background: PubMed 17944293Roberts 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.
- Background: PubMed 20608272May-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.
- Background: PubMed 24477447Case-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.
- Results publication: PubMed 14664311Candler C. Sensory integration and therapeutic riding at summer camp: occupational performance outcomes. Phys Occup Ther Pediatr. 2003;23(3):51-64.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Integration in people with Children, Only, run by Hospital Authority, Hong Kong.
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 4 inclusion and 2 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 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change on the Goal attainment scaling. Changes in functional goals were measured using goal attainment scaling in collaboration with parents and caregivers. (time frame: Pre and post of the treatment intervention, an average of 5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03596515, which also lists 5 linked publications.
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 30 Jul 2018.