Research Request – Updated Literature Review: Sensory products/ weighted items for participants with Autism | FOI document library

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

Summary ……………………………………………………………………………………………………………….. 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.

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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

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

Does ASI intervention meet the Council for Exceptional Children (CEC) criteria for
```
 an evidence-based practice for children with ASD?
```

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)
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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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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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.

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.

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.
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.

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.

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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