Document 5 from FOI23.24 1400 Disclosure log documents.pdf

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FOI 23/24- 1400
DOCUMENT 5
Research Request – Updated Literature Review: Sensory products/
weighted items for participants with Autism
Date
May 14, 2020
Requester
Karyn Mueller (Director - TAB)
Researchers
Jane Scheetz (Research Team Leader)
Research Brief
Perform literature search to confirm that published TAT advice titled - Sensory devices and
toys to assist with sleep and calming for participant who has Autism is current and
effective.
Contents
1. Summary ................................................................................................................................ 2
2. Sensory Integration Therapy Research Evidence .................................................................. 3
2.1 Systematic reviews utilising the principles of Ayres Sensory Integration Therapy ......... 3
2.2 Systematic Reviews – combined Sensory Integration Therapy and Sensory Based
Interventions .......................................................................................................................... 6
2.2.1 Weighted vests ........................................................................................................ 10
2.2.2 Systematic reviews of sensory integration therapy non-specific to ASD ................ 12
3. Reference List ....................................................................................................................... 14
Please note:
The research and literature reviews collated by our TAB Research Team are not to be shared external
to the Branch. These are for internal TAB use only and are intended to assist our advisors with their
reasonable and necessary decision making.
Delegates have access to a wide variety of comprehensive guidance material. If Delegates require
further information on access or planning matters they are to call the TAPS line for advice.
The Research Team are unable to ensure that the information listed below provides an accurate &
up-to-date snapshot of these matters.
Research Request –Literature Review of sensory products/weighted items  for ASD |
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1. Summary

The current TAT digest states Ayres Sensory Integration (SIT) has ‘weak to insufficient
evidence that the intervention can improve outcomes.’ However, evidence supporting the
use of Ayres Sensory Integration Therapy (SIT) as an intervention for Autism Spectrum
Disorder (ASD) is building.
•
A recent systematic review [1] concludes that Ayres SIT is an evidence based practice
for children with ASD between the ages of four and 12. However, the intervention
delivered must be consistent with the principles described by Ayres and
operationalized in the Ayres Sensory Integration Fidelity Measure (ASIFM) [2-6].
•
Interventions that utilise isolated sensory stimuli do not adhere to these principles
and are not recommended.
•
This review included two Randomised Controlled Trials (RCT’s). Both indicated
statistically significant group differences favouring the Ayres SIT group across Goal
Attainment Scale (GAS) outcomes, care giver assistance using the Paediatric
Evaluation of Disability Inventory (PEDI) for self-care and social activities scale.
•
It should be noted that only one of these RCT’s achieved an effect size that would be
considered an important intervention effect (≥0.25). Therefore, results should be
interpreted with caution.
There is weak evidence to support the use of SIT that doesn’t adhere to principles outlined
by Ayres or Sensory Based Interventions (SBI) (both single and multi-sensory).
Generalisability of results is not possible as many reviews included peer reviewed literature
which was of low quality, had small sample sizes or lacked any statistical comparison. The
majority of studies were classified as negative due to a lack of patient benefit, especially
weighted vests and/or blankets. In some cases, SIT may have increased problem behaviour
[7]. Studies that found positive outcomes were often rated as 'suggestive' evidence due to
major methodological limitations.

Single and multi-sensory interventions investigated included: sensory objects, toys, special
seating, eye shields, noise cancelling head set, brushes, lotion, books, games, mats, swing,
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climbing walls, tubes, ball pit, weighted vests, fine motor activities and Snoezelen
equipment.
2. Sensory Integration Therapy Research Evidence
2.1 Systematic reviews utilising the principles of Ayres Sensory Integration
Therapy

Ayres Sensory Integration Therapy (SIT) is one of the most highly utilised interventions for
autism spectrum disorder (ASD), however, a lack of consensus exists regarding its evidence
base. One reason for this is that many studies included in existing systematic reviews and
meta-analyses report on sensory-based interventions which are not consistent with the
principles of Ayres SIT as described by Ayres [2-5], and operationalized in the Ayres Sensory
Integration Fidelity Measure (ASIFM) [6]. Instead, many reviews and meta-analyses include
studies of interventions that use isolated sensory stimuli as the active ingredient of the
intervention (hereafter referred to as sensory-based interventions (SBI)) and do not adhere
to the core principles of Ayres SIT. These sensory-based interventions are largely
characterized as protocols that are passively applied to the child and have been found to
have few positive effects [8]. They lack many of the key ingredients of the ASI such as
individual-tailoring, active engagement of the child, the establishment of a therapeutic
alliance between the child and therapist, targeting the just right challenge and provided
within the context of play [1].

A recent systematic review conducted by Schaaf, Dumont, Arbesman, and May-Benson
(2018) [9] only included studies where the intervention approach adhered to the principles
of ASI.
Summary
1)  Research question/purpose/objective
-  What is the efficacy of occupational therapy using Ayres SIT to support
functioning and participation as defined by the International Classification of
Functioning, Disability and Health for persons with challenges in processing and
integrating sensory information that interfere with everyday life participation?
2)  Methodology
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-  Only studies of level I, II and III were included.
-  NHMRC level of evidence hierarchy = Level III-2
-  Comprehensive search strategy
3)  Results/conclusion
-  5 included studies (3 RCT’s, 1 retroactive analysis and 1 single subject A-B-A
design)
-  Included participants were mostly male and ranged in age from 4 – 9 years
-  Strong evidence that Ayres SIT intervention demonstrates positive outcomes for
improving individually generated goals of functioning and participation as
measured by Goal Attainment Scaling (GAS)
-  Moderate evidence supported improvements in impairment-level outcomes of
improvement in autistic behaviours and skills-based outcomes of reduction in
caregiver assistance with self-care activities
-  Insufficient evidence for outcomes in play, sensory–motor, and language skills
and reduced caregiver assistance with social skills

A further systematic review with far stricter inclusion criteria to establish whether ASI is an
evidence based practice was published in 2019 by Schoen, Lane, Mailloux, May‐Benson,
Parham, Smith Roley and Schaaf [1]. The authors of this review identified ‘major concerns’
with previous reviews which investigate the effectiveness of Ayres SIT such as;
1)  Sensory integration interventions described were not consistent with the principles
of Ayres SIT and were instead a sensory-based intervention.
2)  Fail to provide an adequate description of the phenotypic characteristics of
participants.
3)  Do not present a replicable description of the intervention, or document
intervention fidelity throughout the intervention period using a quantitative
measure.
4)  Outcomes measured in existing studies vary widely and may not be sensitive to the
changes expected following Ayres SIT intervention.
Summary
1)  Research question/purpose/objective
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-  Does ASI intervention meet the Council for Exceptional Children (CEC) criteria for
an evidence-based practice for children with ASD?
2)  Methodology
-  Comprehensive strategy which included 3 stages: (1) electronic database search,
(2) selection of studies using well defined inclusion criteria and (3) evaluation of
included studies using CEC standards.
-  NHMRC level of evidence hierarchy = Level III-2 (this is because one study
included was a retrospective record review and non-randomisation)
-  Quality indicator rating and data extraction was performed by 7 highly
experienced OT’s (>34 years clinical and academic experience)
3)  Results/conclusion
-  3 studies met inclusion criteria
-  Authors state that “Ayres SIT is an evidence based practice is supported by the
finding of two methodologically sound group comparison studies with random
group assignment, positive outcomes, and a collective total of >60 participants.”
-  Only one study achieved a combined effect size of >0.25 (see effect size
interpretation below)
-  The justification and conclusion that ASI is an evidence based practice and
provides positive outcomes needs to be interpreted with caution. Although two
studies found statistically significant results (<0.05) only the study by Schaaf et al.
(2014) [10] achieved effect sizes that would be considered clinically effective.
GAS (p = 0.003, d = 1.2), measures of caregiver assistance in self-care (p = 0.008
Effect size interpretation: Measures either the sizes of associations or the sizes of
differences.

It is standard practice to use effect size in experimental group comparisons rather than
statistical significance to evaluate the strength of the findings, since statistical
significance is influenced by the sample size. Effect size is preferable because it takes into
account the meaningfulness of the outcomes for the population being studied.

The Schoen et al (2019) [8] paper used the guideline that an effect size ≥0.25 is deemed
a substantively important intervention effect and <0.25 is not a substantively important
effect. This means that if two groups' means don't differ by 0.25 standard deviations or
more, the difference is trivial, even if it is statistically significant.
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d = 0.9) and socialization (p = 0.04, d = 0.7) compared to the usual care group
(control).

2.2 Systematic Reviews – combined Sensory Integration Therapy and
Sensory Based Interventions

Description of Sensory-Based Interventions
Sensory-based interventions (SIB’s) typically occur in the child’s natural environment and
consist of applying adult-directed sensory modalities to the child with the aim of producing
a short-term effect on self-regulation, attention, or behavioural organization Common
individual SBIs include weighted vests, brushing, bouncing on a ball, and adapted seating
devices that allow motion. These modalities may be provided in a systematic manner
throughout the child’s day or as needed in response to the child’s self-regulation and are
often combined into what is called a sensory diet.

Lang R, O’Reilly M, Healy O, Rispoli M, Lydon H, Streusand W, Davis T, Kang S, Sigafoos J,
Lancioni G, Didden R. Sensory integration therapy for autism spectrum disorders: A
systematic review. Research in Autism Spectrum Disorders. 2012 Jul 1;6(3):1004-18 [7].
Summary
1)  Research question/purpose/objective
-  To systematically identify, analyse, and summarize research involving the use of
SIT in the education and treatment of individuals with ASD.
2)  Methodology
-  Multiple research databases searched
-  Studies had to include at least on participant with ASD and implement some form
of SIT
-  No restriction on level of evidence included.
-  NHMRC level of evidence hierarchy = Level III-2
-  No differentiation between Ayres SIT and SBI
3)  Results/conclusion
-  Included studies investigated weighted vests, blanket or body sock, swinging,
brushing, joint compressions or stretching, alternative seating, playing with
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water or sand sensory table, chewing on a rubber tube, playing with textured
toys sensory diets, and vestibular or proprioceptive intervention
-  25 included studies provided SIT intervention to a total of 217 individuals with
ASD (*some studies included other diagnoses)
-  14 studies were classified as negative as there was no benefit to the patient. Of
these, four suggested that SIT may have increased problem behaviour. Eight
studies showed mixed results and three were positive. All three positive studies
were rated as 'suggestive' evidence which is the lowest rating due to major
methodological limitations.
-  SIT had no consistently positive effect as a treatment for children with ASD.

Watling R, Hauer S. Effectiveness of Ayres Sensory Integration® and sensory-based
interventions for people with autism spectrum disorder: A systematic review. American
Journal of Occupational Therapy. 2015 Sep 1;69 (5):6905180030p1-2 [11].

Summary
1)  Research question/purpose/objective
-  What is the evidence for SIT and SBIs within the scope of occupational therapy
practice to improve performance in daily life activities and occupations for
children with autism spectrum disorders?
2)  Methodology
-  Multiple research databases searched
-  Studies included in the review are Level I, II, and III evidence. Level IV evidence
was included only when higher level evidence on a given topic was not found
-  NHMRC level of evidence hierarchy = Level III-2
3)  Results
-  23 articles met inclusion criteria
-  506 participants ranging in age from 2 to 39 years. Majority were male
-  Level I SIT studies included significant improvement in individualized goals,
improved sleep, decreased autism mannerisms, and reduced caregiver burden
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-  Level I SIB studies found that active participation in multisensory experiences in
home or clinic settings led to significant improvements in autism symptoms and
behaviours as well as improved scores in cognitive and vocabulary testing
-  Level II SIB studies reported a significant improvement in motor proficiency and
sensory functioning after clinic-based multisensory intervention that included
enhanced vestibular, proprioceptive, and tactile sensory experiences. Increases
in sustained focus, decreases in self-injurious behaviour, and increased perceived
relaxation and happiness were found after independent participation in a
multisensory centre.
-  Level IV SIB study found no effect on self-injurious behaviour, challenging
behaviour, or cortisol levels as a result of uniformly designed sensory diets.
-  Studies which investigated single SBI’s found no effects
4)  Conclusion
-  Moderate evidence was found to support the use of Ayres SIT. The results for
sensory-based methods were mixed. Recommendations include performing
higher level studies with larger samples, using the Fidelity Measure in studies of
Ayres SIT, and using carefully operationalized definitions and systematic methods
in examination of SBIs.

Bodison SC, Parham LD. Specific sensory techniques and sensory environmental
modifications for children and youth with sensory integration difficulties: A systematic
review. American Journal of Occupational Therapy. 2018 Jan 1; 72(1):7201190040p1-1
[12].
Summary
1)  Research question/purpose/objective
-  What is the effectiveness of occupational therapy interventions that use specific
sensory techniques or sensory environmental modifications to support function
and participation of children and youth who have sensory integration difficulties
2)  Methodology
-  Multiple research databases searched
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-  Included interventions: cognitive, parent or teacher coaching, and occupation-
based interventions; specific sensory techniques; and sensory environmental
modifications
-  Levels I, II, and III studies included
-  NHMRC level of evidence hierarchy = Level III-2
3)  Results
-  8 articles met inclusion criteria and interventions included weighted vests,
Qigong massage, slow linear swinging and sensory environmental techniques
-  Qigong massage had 3 high level 3 RCTs which concluded that all reporting
positive outcomes
-  Limited support for weighted vests
-  Insufficient evidence for the effectiveness of slow linear swinging in producing
improved on-task behaviour
4)  Conclusion
-  The evidence is insufficient to draw conclusions regarding slow linear swinging
and incorporation of multisensory activities into preschool settings. Although
Qigong massage provided positive results all RCT’s were conducted by the same
research group which is of concern. Further independent studies are required.

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
[13].
1)  Research question/purpose/objective
-  What is the effectiveness of SIT and SBIs for children with ASD and co-occurring
sensory processing problems on self-regulation and behaviour?
2)  Methodology
-  Thorough search strategy
-  Inclusion criteria: (a) peer reviewed studies published in English, (b) participants
were youth aged 3–21 years, (c) an SIT or SBI was studied, (d) participants were
diagnosed with ASD, and (e) the intervention systematically (i.e. was based on
stated goals) targeted self-regulation and arousal state.
-  NHMRC level of evidence hierarchy = Level III-2
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3)  Results
-  19 studies included. 5 SIT and 14 SIB
-  SIB - Among the seven single-subject studies that applied a weighted vest, only
one demonstrated positive effects. Although these studies provide low-level
evidence, findings suggest that wearing a weighted vest does not result in
improved behaviour (e.g. decreased stereotypic behaviours, improved joint
attention, or reduced distractibility). The evidence for children sitting on balls or
for multisensory stimulation is limited and inconclusive.
-  SIT – Two RCT’s found that SIT is associated with positive effects as measured by
the child’s performance on Goal Attainment Scaling, decreased autistic
mannerisms and improved self-care and social function
4)  Conclusion
-  SIT for children with ASD and sensory processing problems demonstrates positive
effects on the child’s individualized goals; however, additional studies are
needed to confirm these results. Randomized trials using blinded evaluation and
larger samples are needed. SBIs have almost no evidence of positive effects.

2.2.1 Weighted vests

Taylor CJ, Spriggs AD, Ault MJ, Flanagan S, Sartini EC. A systematic review of weighted
vests with individuals with autism spectrum disorder. Research in Autism Spectrum
Disorders. 2017 May 1; 37:49-60 [14].

1)  Research question/purpose/objective
-  The purpose of the study was to evaluate the current literature on the use of
weighted vests with individuals with autism spectrum disorder
2)  Methodology
-  Thorough search strategy
-  Inclusion criteria: (a) use of a group design or single case research design; (b)
inclusion of at least one individual with ASD; (c) examination of the effects of
weighted vests on a particular dependent variable (e.g., aggressive behaviour,
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attention to task); and (d) publication in English in a peer-refereed journal in the
past 25 years.
-  NHMRC level of evidence hierarchy = Level III-2
-  Utilised validated data extraction criteria
3)  Results
-  32 studies met inclusion criteria
-  Relatively small sample sizes across studies. Poor levels of evidence/quality
-  13 were rated as meets evidence standards and four were rated as meets
evidence standards with reservations and fifteen studies were rated as does not
meet evidence standards.
-  A total of 13 children (4–10 years) with ASD participated in the studies rated as
meeting evidence standards or meeting evidence standards with reservations.
-  No effect on engagement, stereotypic behaviour, or problem behaviour as meets
evidence standards with reservations
4)  Conclusion
-  The information from this review indicates that the use of weighted vests with
children with ASD is not an evidence-based practice. Practitioners should be
aware of the literature examining weighted vests when designing interventions
for children with ASD

Gee BM, Peterson TG, Buck A, Lloyd K. Improving sleep quality using weighted blankets
among young children with an autism spectrum disorder. International Journal of Therapy
and Rehabilitation. 2016 Apr 2; 23(4):173-81 [15].

1)  Research question/purpose/objective
-  to explore the efficacy of weighted blankets with children with an autism
spectrum disorder and sleep disturbances using a single case, multiple baseline
design
2)  Methodology
-  Case study (pilot)
-  NHMRC level of evidence hierarchy = Level IV (lowest level)
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-  Inclusion criteria: (a) Diagnosis of ASD, (b) evidence of sleep disturbance
according to the Child Sleep Habits Questionnaire, (c) struggle with sensory over-
reactivity as evidenced by achieving a threshold score on the Sensory Processing
Measure (d) age between 3 and 6, (e) fluent in English, (f) Have internet access,
(g) able to willingly implement the weight vest.
-  Intervention: 9 days of no weighted blanket (baseline), 14 days of weighted
blanket (intervention) and 7 days of no weighted blanket (withdrawal)
3)  Results
-  The overall findings demonstrated minimal improvement of the measured
constructs related to sleep quality in the two participants.
-  Weak evidence shown for total amount of sleep per night and decrease in the
time to fall asleep
-  The findings provide a foundation for the justification of further single subject
designs, using more rigorous designs and measurement.
4)  Conclusion
-   There is need for additional research related to improving the quality of sleep in
children with an ASD and sensory over-responsivity, using more robust single
subject design methodology and measurement resources.

2.2.2 Systematic reviews of sensory integration therapy non-specific to ASD

Two systematic reviews investigating SIT have been conducted that investigate disabilities
other than ASD. Their results and conclusion will be covered for reference.

Leong HM, Carter M, Stephenson J. Systematic review of sensory integration therapy for
individuals with disabilities: Single case design studies. Research in developmental
disabilities. 2015 Dec 1; 47:334-51 [16].

1)  Results
-  17 single case design studies on sensory integration therapy for people with, or
at-risk of, a developmental or learning disability, disorder or delay.
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-  Interventions included: Ayres SIT, vestibular stimulation, tactile stimulation,
proprioceptive stimulation, sensory diet, weighted vest, Wilbarger, joint
compression
-  Based on limited comparative evidence, functional analysis-based interventions
for challenging behaviour were more effective that SIT.
2)  Conclusion
-  Overall the studies do not provide convincing evidence for the efficacy of sensory
integration therapy. Given the findings of the present review and other recent
analyses it is advised that the use of SIT be limited to experimental contexts

Barton EE, Reichow B, Schnitz A, Smith IC, Sherlock D. A systematic review of sensory-
based treatments for children with disabilities. Research in Developmental Disabilities.
2015 Feb 1; 37:64-80 [17].

1)  Results
-  Thirty studies involving 856 participants met our inclusion criteria and were
included
-  Interventions included: Sensory objects, toys, pool, special seating, eye shields,
noise cancelling head set, brushes, lotion, books, games, mats, swing, climbing
walls, tubes, ball pit, weighted vests, Vestibular, tactile, and proprioceptive-
based activities, fine motor activities, Snoezelen equipment,
-  Considerable heterogeneity was noted across studies in implementation,
measurement, and study rigor. The research on sensory-based treatments is
limited due to insubstantial treatment outcomes, weak experimental designs, or
high risk of bias.
2)  Conclusion
-  Based on the analysis, sensory-based treatments are more likely to be ineffective
than effective for children with disabilities

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3. Reference List

1.  Schoen SA, Lane SJ, Mailloux Z, May‐Benson T, Parham LD, Smith Roley S, Schaaf RC.
A systematic review of Ayres Sensory Integration intervention for children with
autism. Autism Research. 2019 Jan;12(1):6-19.
2.  Ayres AJ. Sensory integration and learning disorders. Western Psychological Services;
1972.
3.  Ayres AJ. Sensory integration and learning disorders, Western Psychological Services.
Los Angeles, CA. 1972.
4.  Ayres AJ. Sensory integration and praxis tests (SIPT). Western Psychological Services
(WPS); 1996.
5.  Ayres AJ, Robbins J. Sensory integration and the child: Understanding hidden sensory
challenges. Western Psychological Services; 2005.
6.  Parham LD, Cohn ES, Spitzer S, Koomar JA, Miller LJ, Burke JP, Brett-Green B,
Mailloux Z, May-Benson TA, Roley SS, Schaaf RC. Fidelity in sensory integration
intervention research. American Journal of Occupational Therapy. 2007 Mar
1;61(2):216-27.
7.  Lang R, O’Reilly M, Healy O, Rispoli M, Lydon H, Streusand W, Davis T, Kang S,
Sigafoos J, Lancioni G, Didden R. Sensory integration therapy for autism spectrum
disorders: A systematic review. Research in Autism Spectrum Disorders. 2012 Jul
1;6(3):1004-18.
8.  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.
9.  Schaaf RC, Dumont RL, Arbesman M, May-Benson TA. Efficacy of occupational
therapy using Ayres Sensory Integration®: A systematic review. American Journal of
Occupational Therapy. 2018 Jan 1;72(1):7201190010p1-0.
10. Schaaf RC, Benevides T, Mailloux Z, Faller P, Hunt J, Van Hooydonk E, Freeman R,
Leiby B, Sendecki J, Kelly D. An intervention for sensory difficulties in children with
autism: A randomized trial. Journal of autism and developmental disorders. 2014 Jul
1;44(7):1493-506.
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11. Watling R, Hauer S. Effectiveness of Ayres Sensory Integration® and sensory-based
interventions for people with autism spectrum disorder: A systematic review.
American Journal of Occupational Therapy. 2015 Sep 1;69(5):6905180030p1-2.
12. Bodison SC, Parham LD. Specific sensory techniques and sensory environmental
modifications for children and youth with sensory integration difficulties: A
systematic review. American Journal of Occupational Therapy. 2018 Jan
1;72(1):7201190040p1-1.
13. 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.
14. Taylor CJ, Spriggs AD, Ault MJ, Flanagan S, Sartini EC. A systematic review of
weighted vests with individuals with autism spectrum disorder. Research in Autism
Spectrum Disorders. 2017 May 1;37:49-60.
15. Gee BM, Peterson TG, Buck A, Lloyd K. Improving sleep quality using weighted
blankets among young children with an autism spectrum disorder. International
Journal of Therapy and Rehabilitation. 2016 Apr 2; 23(4):173-81.
16. Leong HM, Carter M, Stephenson J. Systematic review of sensory integration therapy
for individuals with disabilities: Single case design studies. Research in
developmental disabilities. 2015 Dec 1;47:334-51.
17. Barton EE, Reichow B, Schnitz A, Smith IC, Sherlock D. A systematic review of
sensory-based treatments for children with disabilities. Research in Developmental
Disabilities. 2015 Feb 1;37:64-80.

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