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08/09/2015

Evidence for Ayres Sensory Integration


Roseann C. Schaaf, PhD., OTR/L, FAOTA
Thomas Jefferson University
Philadelphia PA

What Constitutes an Evidence Based


Practice?

According to 3 separate sources Occupational


Therapy using Ayres Sensory Integration
meets the criteria for an evidence-based
practice

08/09/2015

The National Professional Development


Center on Autism Spectrum Disorders
To be considered an evidence-based practice for individuals with ASD,
efficacy must be established through peer-reviewed research in scientific
journals using:
Two high quality randomized (experimental) or quasi-experimental
group design studies; or
Five high quality single-subject design studies by three different
investigators or research groups; or
A combination of one high quality randomized or quasiexperimental group design study and three high quality single
subject design
What is an Evidence-Based Practice? Available at
http://autismpdc.fpg.unc.edu/content/evidence-based-practices

Council for Exceptional ChildrenGuidelines for Identifying Evidencebased Practices in Special Education
Effective practices should be based on multiple, high-quality studies that
use experimental research designs and demonstrate robust effects
Council of Exceptional Children (CEC) created an EBP Workgroup
charged with creating and vetting a revised set of EBP standards for
special education.
Identified Quality Indicators (QUIs) and standards for classifying EBP
in special education
Cook, B.G. et al (2015). CECs standards for classifying the evidence base of practices in
special education. Remedial and Special Education, 36(4), 220 234. DOI:
10.1177/0741932514557271

08/09/2015

Standards for classifying Evidence-based


Practices (CEC)
Two methodologically sound group comparison studies with
random assignment to groups, positive effects, and at least 60
total participants across studies;
Four methodologically sound group comparison studies with
non-random assignment to groups, positive effects, and at
least 120 total participants across studies; or
Five methodologically sound single-subject studies with
positive effects and at least 20 total participants across studies

Quality Indicators for EBP (CEC)


QIs were identified to examine methodological soundness of studies.
Sufficient information must be presented on:
Context or setting
Participants (e.g. demographics, disability and methods for
determining

Interventionists training, qualification


Intervention describes features of the practice, materials,
replicable, interventionists actions
Implementation and measurement of fidelity

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Quality Indicators
Internal Validity
Description of services provided and comparison conditions and
phases including attrition
That the researcher controls and systematically manipulated the
independent variable
Describes group assignment or randomization
Outcome Measures/dependent variable
Appropriate, clearly defined, described, applied
Data Analysis
Appropriate, clear, effect size is reported or can be calculated

U.S. Preventative Services Task Force


Guidelines for Evidence Reviews
Strong evidence includes consistent results from well-conducted studies,
usually at least two randomized controlled trials (RCTs).

Moderate evidence indicates one RCT or two or more studies with lower levels

of evidence. Note that some inconsistency of findings across individual wellconducted studies could preclude a classification of strong evidence and result
instead in a designation of moderate evidence.
Limited evidence indicates few studies, flaws in the available studies, and some
inconsistency in the findings across individual studies.
Mixed evidence indicates that the findings were inconsistent across studies in a
given category.
Insufficient evidence indicates that the number and quality of studies are too
limited to make any clear classification

http://www.uspreventiveservicestaskforce.org/uspstf/grades.htm

08/09/2015

PRISMA Guidelines for Evidence-based


Reviews (Adopted by AJOT)
Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009). Preferred Reporting Items for Systematic
Reviews andMeta-Analyses: The PRISMA Statement. PLoS Med 6(6): e1000097. doi:10.1371/journal.pmed1000097

The American Journal of Occupational Therapy (AJOT) uses the Preferred


Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)
guidelines as a basis for systematic reviews. Please refer to
http://www.prisma-statement.org/statement.htm
The PRISMA checklist is available at http://www.prismastatement.org/2.1.2%20-%20PRISMA%202009%20Checklist.pdf.
PRISMA Transparent Reporting of Systematic Reviews and Meta-Analyses

Levels of Evidence
Level I
Level II
Level III
Level IV
Level V

Systematic reviews, meta-analyses, randomized controlled trials


Two groups, nonrandomized studies (e.g., cohort, case-control)
One group, nonrandomized (e.g., before & after, pretest & posttest)
Descriptive studies that include analysis of outcomes (singlesubject design, case series)
Case reports and expert opinion that include narrative literature
reviews and consensus statements

From Evidence-Based Medicine: What It Is and What It Isnt, by D. L. Sackett, W. M.


Rosenberg, J. A. Muir Gray, R. B. Haynes, & W. S. Richardson, 1996, British Medical
Journal, 312, pp. 7172. Copyright 1996 by the British Medical Association. Adapted
with permission.

08/09/2015

ASI Now Evidence-based

Schaaf, Benevides, Mailloux, Faller, Hunt, van


Hooydonk, Freeman, Leiby, Sendecki, & Kelly
JADD, 2014

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Effectiveness of SI for children with


ASD
Schaaf, et al., (2014)
In a randomized trial of 32 children with autism, the
group who received OT-SI for 10 weeks, 3 X per week
showed statistically significant improvements in
primary measure of Goal Attainment, as well as
secondary outcome measures showing statistically
significant decreases in caregiver assistance needed for
self-care and social activities.
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Meets Quality Indicators for Evidencebased Practice

Funded by the Autism Speaks Foundation


Context: Outpatient setting; Clinic setting
Participants well characterized sample
4-8 years of age
Diagnosed with ASD using ADOS and ADI-R
Developmental Quotient: Non-Verbal IQ >65
No other co-morbid genetic or developmental conditions (i.e.
Fragile X, CP)
Demonstrate difficulty processing and integrating sensory
information as measured by the Sensory Profile and/or the SIPT
Interventionists
Occupational Therapists certified in sensory integration (USC/WPS
courses)
Additional training on manualized approach

Design &
Methods

Children who do not


meet inclusion criteria
excluded

Referral
& Screening
Phenotypic evaluation for
eligibility
ADOS, ADIr, IQ, SSP, SIPT

Informed Consent
Pre-treatment Assessments
Analysis of Assessment Data
Goal writing with Parent: GAS

PEDI, PDDBI
WHO-QOL
SEQ
Vineland- II
Data Driven Decision
Making
Hypothesis generation

Randomization
Experimental Group OT/SI
30 sessions/10 weeks
N= 17

Manualized
Protocol

Control Group
Usual Care, 10 weeks
n = 15

Post Test
SIPT, SEQ, Vineland, PEDI, QOL, PDDBI
Post GAScale Interview

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Comprehensive Assessment
History and occupational profile/Parent
Interview
Sensory Motor Assessment
Sensory Integration and Praxis Tests
Sensory Profile
Sensory Experiences Questionnaire (SEQ
Baranek, 2006)

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Outcome Measures (dependent Variables)

Primary Outcome Measure: Goal


Attainment Scales
Secondary Measures
Pediatric Evaluation of Disability Inventory

(Haley, Coster, et al - PEDI)


Pervasive Developmental Disorder Behavior
Inventory (PDDBI)
Vineland Adaptive Behavior Scales (Vineland-II)

Manualized, Replicable, Intervention


Active, individuallytailored sensory motor
activities designed to
address underlying
factors affecting
participation.
10 weeks 3X/weeks
Follows manualized
protocol
Fidelity was tested with
validated measure
(Parham, et al 2011)

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Use Data Driven Decision Making: A systematic


approach for reasoning and decision making
(Schaaf and Mailloux, 2015)
Uses data to guide assessment
and intervention
Analysis and interpretation of
assessment data to identify the
sensory motor factors
hypothesized to impact
participation.
Proximal (sensory motor) and
distal (participation-based)
outcomes identified and
measured.

DDDM

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08/09/2015

Clinician Guide for Implementing


Ayres Sensory Integration
(Schaaf and Mailloux, 2015)

Findings

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Primary Outcome

Primary Outcome:

Parent-Rated
Goal
Attainment Scale:
Goal
Attainment
Scale
Group Comparisons

80

70

56.53

GAS T-score

60

50

43
40

30

t= -3.23, df=23
p = .003**
E.S. = 1.2

20

10

Usual Care, n=14

OT/SI Treatment, n=17

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PEDI
Control

p value

Effect Size

3.7

0.1976

0.5

0.69

0.0

0.0968

0.3

Treatment

Median Change Median Change

Functional Skills
Self Care

1.7

Mobility
Social
Function

0
1.1

Caregiver Assistance
Self Care

1.3

12.2

0.0076**

0.9

Mobility

0.6856

0.2

Social

13.5

0.0394*

0.7

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PDDBI
Median change from pre-intervention
Control

Treatment

p value

Aggressiveness
Arousal Regulation
Problems

-2

-3

0.8192

-3

-6

0.3859

Specific Fears
Ritualism/
Resistance to
Change
Semantic/Pragmati
c Problems
Sensory/Perceptual
approach
Behaviors

-1

-3

0.4321

-2

-2

0.5758

-1

0.4442

-0.5

-5

0.0637

Effect size

-0.4

-0.4

-0.6

PDDBI

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08/09/2015

PDDBI Graphs

Vineland Adaptive Behavior


Scales II
Control

Treatment

p value

(Change Score) (Change Score)


Communication1

0.2038

Daily Living1

0.1763

Socialization Skills1
Motor Skills

-2
-3

3
0

0.2928
0.4814

Adaptive Behavior
Composite1

0.3130

1Standard

Score

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08/09/2015

Additional Evidence for ASI


Pfeiffer, et al., 2011

Comparative Effectiveness Study: OT ASI vs Fine


Motor
37 children with ASD aged 6-12; randomized
18 tx sessions over 6 weeks
Used ASI Fidelity Measure
RESULTS: Children with ASD had greater gains on
GAS and a significant decrease in autistic
mannerisms in comparison with the fine motor
intervention
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Pfeiffer, et al., 2011 (continued)


Both SI and FM groups demonstrated
significant improvements toward goals on the
GAS
The SI group demonstrated more significant
improvement than the FM group in the
attainment of goals as rated by parents
(p < .05, ES size 0.125) and
teachers (p < .01, ES 0.360)

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08/09/2015

Conclusions Meets CEC Criteria


ASI meets the criteria for an evidence-based
intervention by CEC: 2 RCTs; 69 subjects
total; meet quality indicators of CEC
Two methodologically sound group comparison studies with random
assignment to groups, positive effects, and at least 60 total participants
across studies

Single Subject Studies Provide Further


Support
Five methodologically sound single-subject studies with
positive effects and at least 20 total participants across studies

Case-Smith & Bryan, 1999


Linderman & Steward, 1999
Watling & Dietz, 2007
Case-Smith, J., & Bryan, T. (1999). The effects of occupational therapy with sensory integration emphasis
on preschool-age children with autism. American Journal of Occupational Therapy, 53, 489497.

Linderman, T. M., & Stewart, K. B. (1999). Sensory integrative-based occupational therapy and functional
outcomes in young children with pervasive developmental disorders: A single-subject study. American
Journal of Occupational Therapy, 53, 207213

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08/09/2015

Additional Studies
Humphries, T., Wright, M., McDougall, B., & Vertes, J. (1990). The
efficacy of sensory integration therapy for children with learning disability.
Physical and Occupational Therapy in Pediatrics, 10, 117.
doi:10.1300/J006v10n03_01
Miller, L. J., Coll, J. R., & Schoen, S. A. (2007). A randomized controlled
pilot study of the effectiveness of occupational therapy for children with
sensory modulation disorder. American Journal of Occupational Therapy,
61, 228238
Miller, L. J., Schoen, S. A., James, K., & Schaaf, R. C. (2007). Lessons
learned: A pilot study on occupational therapy effectiveness for children
with sensory modulation disorder. American Journal of Occupational
Therapy, 61, 161169.

Lessons Learned:
Be Clear and Systematic!
Devlin, et al 2010 JADD
Comparison of the effects of sensory integration and
behavioral intervention for addressing problem
behaviors
N = 4 boys with challenging behaviors
Conclusion: behavioral interventions effective in
reducing problem behaviors but SI was not.
SI: 15 minute access to equipment provided during school
day for approx. 6 times/day

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08/09/2015

Analysis (Schaaf & Blanche, 2011)


Sensory Integration Therapy
not an accurate representation of the sensory integrative
approach (OT/SI)
Did not use ASI Fidelity Measure

Failure to conduct a systematic assessment to guide


intervention
Inaccurate use of literature
Does not include contemporary or classic literature

We Need to Continue to Generate


Evidence!
Progress made

Studies of OT/SI
ASI Fidelity Measure (Parham, et al 2001; 2011)
Evidence Reviews (AJOT; Reichow.Volkmar Book 2011)
Subtype studies: Miller, et al; Davies, 2010)
Physiological studies (Schaaf & Benevides; Miller, Schoen, et al; Parush, et al)

Each of you can participate we need more


1. Be systematic in your approach
2. Use systematic clinical reasoning based on theory
3. Articulate hypothesis

Identify participation limitations


Obtain a history to guide systematic assessment
Assess, assess, assess
Use theory to generate hypothesis and underlying mechanisms
Identify outcomes
4. Test Hypotheses by charting outcomes
5. Publish, publish, publish

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08/09/2015

Thank you!
For more information on Jeffersons Programs go to
Jefferson.edu/occupational therapy
http://www.jefferson.edu/university/health_professions/depart
ments/occupational_therapy/programs/certificates.html

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