Effect of Ayres Sensory Integration Therapy on Sensory, Motor, Cognitive, Behavioral Skills and Social Participation in Children With Attention Deficit Hyperactivity Disorder: Randomized Controlled Trial
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity, Sensory Integration Disorder, Motor Activity, Cognitive Deficit in Attention, Behavior Hyperactive, Emotional Regulation, Social Skills
Sponsor: Hacettepe University

                 
 
 
 
 
 
 
 
 
 
 
 
27.12.2022 
 
 
Issue Number:2022/4453 
 
 
 
 
 
 
 
 
 
 
 
 
 
ANKARA SOCIAL SCIENCES UNIVERSITY 
INSTITUTIONAL ETHICS COMMITTEE OF 
SOCIAL SCIENCES AND HUMANITIES RESEARCH 
AND PUBLICATION 
 
 
 
 
 
 
CERTIFICATE OF ETHICS APPROVAL 
 
 
 
 
RESEARCH METHOD 
 
Randomized Controlled Trial 
 
STUDY TITLE 
Effect of Ayres Sensory Integration Therapy on 
Sensory, Motor, Cognitive, Behavioral Skills 
And Social Participation in Children With 
Attention Deficit Hyperactivity Disorder: 
Randomized Controlled Trial 
 
PRINCIPAL RESEARCHER NAME 
SURNAME 
 
Busra KAPLAN, OTR/L 
 
COMMITTEE DESICION  
APPROVED 
 
ASSISTANT RESEARCHERS 
1- Prof. Dr. Gonca BUMIN 
2- Ass. Prof. Hakan OGUTLU 
3- Prof. Dr. Mehmet Hakan TURKCAPAR 
 
 
 
 

 
 
 
 
ANKARA SOCIAL SCIENCES UNIVERSITY 
ETHICS COMMITTEE APPROVAL 
CERTIFICATE 
APPLICATION FORM 
 
 
 
STUDY PROTOCOL AND STATISTICAL ANALYSIS PLAN 
1. Study Title:  
EFFECT OF AYRES SENSORY INTEGRATION THERAPY ON SENSORY, MOTOR, 
COGNITIVE, BEHAVIORAL SKILLS AND SOCIAL PARTICIPATION IN CHILDREN WITH 
ATTENTION DEFICIT HYPERACTIVITY DISORDER: RANDOMIZED CONTROLLED 
TRIAL 
2. Purpose and Importance of Research: 
According to the definition of the Diagnostic and Statistical Manual of Mental Disorders, 5th 
Edition (DSM-5), Attention Deficit Hyperactivity Disorder (ADHD) is a behavioral and 
neurodevelopmental disorder characterized by inattention, impulsivity and hyperactivity, 
negatively affecting the functionality and development of the individual. It has been reported to be 
among the most common disorders with a prevalence of over 5% in childhood (1, 2). 
 
In the diagnosis of attention deficit and hyperactivity disorder, the presence of inattention, 
hyperactivity and impulsivity problems are the main symptoms. inattention in children with ADHD; 
It is manifested by behaviors such as short attention span, avoidance of tasks, inability to focus, 
daydreaming, and disorganization. Hyperactivity refers to excessive motor activity, excessive 
fidgeting and speech impulsiveness that are not appropriate for the situation. Impulsivity, on the 
other hand, manifests itself with features such as haste, not being able to postpone requests, having 
difficulty interrupting others' words and waiting for their turn, and making important and sudden 
decisions without considering long-term consequences (2, 3). 
 
ADHD findings affect the behavioral, emotional, academic, social and cognitive functions of 
children, and behavioral outcomes that are not compatible with the age of the children can be 
observed. These symptoms significantly affect children's activities of daily living, academic skills 
and social participation. In addition, because it continues throughout life, it negatively affects the 
quality of life of family members such as parents, siblings, and caregivers (4). 
  

Given the multidimensional nature of ADHD, current research has largely focused on cognitive 
and behavioral skills related to attention and executive functions, or social behavioral skills such as 
social participation and impulsivity, but insufficient attention has been paid to sensorimotor skills. 
However, the literature indicates the presence of sensory integration problems in children with 
ADHD. Sensory integration is defined as the neurological process in which the person processes 
the sensory experiences from the body and the external environment in a way that allows the body 
to be used meaningfully and purposefully (5). This process consists of different steps in which the 
central nervous system recognizes, organizes, perceives, interprets and responds to sensory 
information (6). Sensory integration disorder (DDD) is the general descriptive expression used for 
the processing problem in one or more of these steps. Researchers divide DDD into two basic 
classes as sensory modulation and sensory perception-based disorders (7). 
 
Sensory modulation disorder has two basic manifestations: above-normal reactivity (defensive and 
avoidant responses) and below-normal reactivity (poor recording). Difficulties in attention, emotion 
regulation, and activity, avoidance of sensory experiences, sensory seeking, and poor self-esteem 
are behavioral traits that can be seen in individuals with sensory modulation difficulties. Sensory 
perception-based disorders are; poor postural-ocular control, sensory discrimination, body 
awareness, difficulties with vestibular-based bilateral integration and sequencing, and 
somatodyspraxia. Behavioral consequences of sensory integration disorders based on sensory 
perception can be seen as poor self-esteem or self-efficacy, avoidance of motor activities, weak fine 
and gross motor skills, visual-motor coordination and organizational skills, and sensory seeking 
(7). Sensory modulation problems are determined by family interviews and caregiver scales 
(Sensory Profile or Sensory Processing Scale), while sensory perception-based difficulties are 
determined by standard tests (Sensory Integration and Praxis Test) and in some cases, caregiver 
scales (8). 
 
In the 1950s, Jean Ayres developed the theory of sensory integration and defined typical sensory 
development, defined sensory integration disorder in which we defined atypical sensory-behavioral 
responses, assessment tools and the way of applying Ayres Sensory Integration therapy (5, 9). In 
studies on Ayres Sensory Integration therapy, it is stated that when the intervention results are 
examined, improvement is observed in the areas of sensory, motor, cognitive, behavioral, social 
participation, and opactional performance (10). 
 

Many studies conducted with individuals with ADHD report that their ability to perceive and 
process sensory information is affected (11-14). In addition, it has been shown that children with 
ADHD have difficulties in producing appropriate sensory responses at school, at home and in social 
environments in relation to their sensory processing difficulties (11), and these difficulties cause 
problems in daily living activities and performance in children (15, 16). 
 
In studies conducted with children with ADHD, the presence of problems related to sensory 
processing was determined by both behavioral and neurophysiological measurements. Electroderm 
In a study conducted with skin responses, it was found that children with ADHD had more sensory 
reactivity responses than the control group (12). Another study conducted with EEG showed that 
children with ADHD with tactile sensitivity and children with ADHD without ADHD differ in the 
processing of somatosensory brain areas (13). Studies evaluating behaviors have revealed results 
that support these neurophysiological findings. Dunn and Benett's study using the Sensory Profile 
(DP) family scale revealed that individuals with ADHD differ in all 14 subtest sections of the DP 
family scale, including hearing, touch, multi-sensory processing, emotional/social responses, and 
behavioral outcomes (11). In another study conducted with the same scale, individuals with ADHD 
showed higher sensory reactivity responses than their controls, supporting previous findings (14). 
Although there are many studies using family scales such as DP, which measures sensory 
modulation skills in individuals with ADHD, there are limited studies evaluating sensory perception 
and sensory perception-based problems. In another study, individuals with ADHD had lower scores 
in the somatosensory perception tests of the DBPT when compared to the healthy group, and it was 
revealed that these individuals had a weak tactile and proprioceptive perception (13). 
 
Although there are studies in the literature showing the presence of DDD in children with ADHD, 
most researchers have studied a similar profile, such as sensory modulation disorder, and few have 
investigated all components of sensory integration (such as sensory perception, praxis) (17). More 
research is needed to confirm the effects of Ayres Sensory Integration therapy in children with 
ADHD and the possible relationship between DDD-based difficulties in activities of daily living 
and ADHD symptoms. In our study, it was aimed to investigate the effect of Ayres Sensory 
Integration therapy on sensory, motor, cognitive, behavioral and social participation in children 
with ADHD in the light of extensive literature and recommendations. 
 

3. Benefits and Risks Expected from Study 
The evaluations to be made within the scope of the study do not involve any risk. At every moment 
of Ayres Sensory Integration Therapy applications, there will be at least one researcher, including 
our volunteer child and their parents. Considering all this information, participation in our study 
does not pose a risk. Difficulty with sensory and motor skills is a common problem for children 
with attention deficit hyperactivity disorder. With a structured sensory integration therapy 
application, it is aimed to reduce the sensory, motor and cognitive difficulties of children in their 
daily lives. 
4. Materials and Methods 
4.1. Study Place: 
In this research, PhD student Büşra Kaplan, Dr. Hakan ÖĞÜTLÜ, Prof. Dr. Hakan TÜRKÇAPAR 
and Prof. Dr. Gonca BUMİN will take part in the evaluation, data analysis and writing stages. The 
research will take place in the pediatric rehabilitation unit of Hacettepe University, Department of 
Occupational Therapy. 
 
4.2. Time to Study: 
The study is planned to be completed between February 2023 and April 2024, starting immediately 
after the approval of the ethics committee. 
 
4.3. Study Population, Sample, Research Group: 
Study group and control group will be compared in the research. The change between the last 
evaluation and the first evaluation will be calculated and a comparison of this change between the 
two groups will be made. T-test will be used in independent groups for this comparison. The effect 
size was predicted to be 0.8. With 5% margin of error and 80% power, the sample size was 
calculated as (45 + 45) 90 for the groups. Participants will be divided into two groups as training 
group and control group. All volunteering children will be included in the study, taking into account 
the inclusion and exclusion criteria. 
Inclusion criteria; 
a. To be in the age range of 6-8, 
b. Being diagnosed with Attention Deficit Hyperactivity Disorder according to the DSM-V criteria, 
c. Continuing school education, 
d. Having agreed to participate in the study after being informed about the research. 
Exclusion criteria; 
Children with additional physical and neurological problems will be excluded from the study.  
 

4.4. Type of Study: Randomized Controlled Trial 
The simple randomization method will be used in this study, and volunteers will be divided into 
study and control groups at random and with equal probability, taking into account the inclusion 
and exclusion criteria. For simple randomization, block randomization method will be used. 
4.5. Required Manpower for Research: 
Dr. Hakan ÖĞÜTLÜ and Prof. Dr. Hakan TÜRKÇAPAR will diagnose patients and direct them 
for research. The first and second evaluations were blinded by Prof. Dr. Gonca BUMİN will be 
made Ayres Sensory Integration Therapy be implemented by Büşra KAPLAN, MSc. Büşra Kaplan 
has a Ayres Sensory Integration Therapy Practitioner Certificate.  
4.6. Data Collection Tools of the Research: 
Sociodemographic Information Form 
Participants' age, gender, time of diagnosis, number of siblings, parental education and employment 
status, etc. sociodemographic information form which contains the information will be used. 
Sensory Profile (SP) 
The Sensory Profile (SP) is a family-reported scale that provides data on children's reactions to 
sensory events in daily life, how sensory behaviors can contribute to performance in daily life, and 
what difficulties they cause in performance. It consists of 125 questions that can be applied between 
the ages of 3-10 (18). It has been found that SP effectively distinguishes between typically 
developing children and children with various developmental difficulties (19). Turkish adaptation 
study was done by Kayıhan et al. (20). 
 
Sensory Integration and Praxis Test (SIPT) 
The Sensory Integration and Praxis Test (SIPT), developed by Ayres, is a standardized 
performance-based observational test that evaluates sensory perception and sensory perception-
based skills in detail in children between the ages of 4 and 8 years and 11 months (21). SIPT is one 
of the important gold tests in evaluating sensory development and consists of 17 subtests. These 
subtests provide information on visuospatial perception, visual discrimination, tactile perception, 
kinesthesia, following verbal instructions, visual motor planning, imitation of body and mouth 
movements, balance, bilateral coordination, sequencing of movements, and vestibular processing. 
There is no Turkish reliability and validity study of this test, which evaluates the child's 
performance, but it is applied by therapists who have international certification in this regard in our 
country. On the other hand, some studies have suggested that cultural differences do not affect SIPT 

scores (22, 23). In our study, it was decided to use SIPT to compare pre-intervention and post-
intervention sensory development scores. 
 
Emotion Regulation Checklist (ERC) 
The Emotion Regulation Checklist (ERC) is a 24-item scale developed by Shields and Cicchetti to 
evaluate the emotion regulation competence of children aged 6-13 and can be evaluated by both 
parents and teachers (24). The items of the scale evaluate affect lability/negativity and emotion 
adjustment with the items changing on the plot of "never" and "almost always" on a 4-point Likert 
scale. Its Turkish adaptation was made by Gül Kapçı et al. (25). 
 
Stroop Test TBAG Form (Stroop TBAG) 
The Stroop Test TBAG Form (Stroop TBAG) is one of the golden tests used to measure selective 
attention and ability to shift attention, focusing on the color used in the spelling of the word and the 
disruptive effect of the color in the pronunciation of the word (26). The test has cards with color 
names printed in different colors. The form includes yellow, blue, red and green colors and color 
names. The dimensions of the form consist of four white cards. On the first card, there are black 
color names on a white background, on the second card, each color name is different from its own 
color, on the third card there are circles of different colors, and on the fourth card there are neutral 
words such as “as much, weak, medium” printed with different colors (27). Stroop test TBAG form 
is applied in five sections. In the first application part, the words written in black on the first card 
are required to be read. In the second part, the color names It was requested to read in the area 
where it was written. In the third part, it is required to say the color names of the circles in different 
colors, in the fourth part the colors of the neutral words printed in different colors, and in the fifth 
part, using the card in the second part to be read again. It is one of the important cognitive 
evaluations that evaluates the child in terms of attention and executive functions, with the brain 
concentrating on two different situations at the same time (26, 27). Turkish standardization of 
Stroop TBAG in children aged 6-11 was performed by Kılıç et al. (28). 
 
Childhood Executive Functions Inventory (CHEXI) 
Childhood Executive Functions Inventory (CHEXI) is a scale consisting of 26 questions for 
children aged 4-12 years, developed by Lisa B. Thorell and Lilianne Nyberg as a measurement 
focusing especially on executive functions (29). CHEXI is divided into 4 subgroups: working 
memory, planning, inhibition and regulation. Questions are answered by parents or teachers. A 

rating from 1 to 5 is made according to the accuracy of the statement in each item. It was translated 
and adapted into Turkish by Ezgi Kayhan (30). 
 
Participation and Environment Scale for Children and Youth (PEM-CY) 
The Participation and Environment Scale for Children and Youth (PEM-CY) is a 28-item 
questionnaire assessing participation in children aged 5-17 years. It is a family-reported scale that 
questions the child's participation in school, home and society. It is the first survey to question 
participation in environmental conditions. In the content of the questionnaire, playing games, 
participating in artistic activities, watching television, school activities, social interaction and 
participation in household chores are evaluated (31). Turkish validity, reliability and psychometric 
properties were studied by Kaya Kara et al. (32). 
 
Conners Teacher Rating Scale (CTRS) and Conners Parent Rating Scale (CPRS) 
Conners Teacher Rating Scale (CTRS) and Conners Parent Rating Scale (CPRS) are important 
behavioral screening and diagnostic scales that have a wide range between the ages of 3-17 and are 
used quite frequently especially in ADHD (33). CTRS consists of 28 items developed to grade 
students' classroom behaviors by their teachers (34). The normative data of the Turkish translation 
of the CTRS were obtained, and its validity and reliability were studied (35). CPRS, on the other 
hand, is a family-reported scale consisting of a total of 48 items, the Turkish adaptation of which 
was made by Dereboy et al. The questions in the scale are answered by the parents on a 4-point 
Likert scale (36). 
 
Bruininks-Oseretsky Motor Proficiency Test-2 (BOT-2) 
Bruininks-Oseretsky Motor Proficiency Test-2 (BOT-2) is a test developed for children aged 4-21 
and developed to measure the motor functions of children. BOT-2 is an observational assessment 
evaluating motor performance, consisting of 8 subtests and 12 items in total. It consists of fine 
motor accuracy, fine motor integration, dexterity, bilateral coordination, balance, upper extremity 
coordination, endurance, speed and agility subtests (37). The Turkish validity and reliability study 
of the test was performed by Köse et al. (38). 
 
Goal Attainment Scale (GAS) 
The Goal Attainment Scale (GAS) is used to evaluate the achievement of functional therapy goals 
in children receiving treatment in pediatric services. It helps to set priorities and clear goals for 

intervention. It provides the child's continuous interest in the set goals and offers a person-centered 
approach (39). The determined goals should be specific, measurable, achievable, relevant and well-
timed (40). While applying GAS, goals are set for the child and possible outcomes are defined for 
each goal. After a certain intervention, the functional status of the child is determined again. GAS 
consists of 5 points as -2, -1, 0, +1 and +2. A score of -2 indicates the child's pre-intervention 
baseline level, a score of -1 indicates a development below the expected attainment level, a score 
of 0 indicates an expected attainment level, a score of +1 indicates a better-than-expected 
achievement, and a score of +2 indicates that the child performs much better than expected (39, 
40). 
 
4.7. Collection of Data: 
The data will be collected by the occupational therapist from the volunteer participants by face-to-
face interview method, and consent and evaluation forms will be collected. 
 
4.8. Intervention Program: 
Individuals will be interviewed for the Informed Consent Form. Consent will be obtained from each 
individual who volunteers to participate in the study. Consent forms will be given in writing and 
will be requested back once signed. 
 
Participants signing the Informed Consent Form will form the working group, taking into account 
the inclusion and exclusion criteria. This study group will be divided into two as training and control 
groups by simple randomization method. After the training and control groups are determined as a 
result of randomization, an initial evaluation will be made for all participants separately. Ayres 
Sensory Integration Therapy will be applied to the training group for 10 weeks, 3 days a week (30 
sessions), 60 minutes per session. Final assessments will be made at week 11 of therapy. In the 
control group; An appointment will be made 10 weeks after the initial assessment. After 10 weeks, 
final evaluations will be made for control. After the final evaluation, 30 sessions of Ayres Sensory 
Integration Therapy will be applied for 10 weeks, 3 days a week, similar to the control group. In 
the Ayres Sensory Integration Therapy application, the therapist will provide interviews with the 
child and their parents in structured environments, and the parents will be asked to repeat the session 
by explaining the goals in an explanatory way after the session. 
 
Ayres Sensory Integration Therapy will be administered in accordance with the Ayres Sensory 
Integration Fidelity Measure (ASI-FM). ASI-FM is a manual protocol based on Ayres Sensory 

Integration principles (41). This protocol is applied by certified therapists. Researcher Büşra Kaplan 
has this certificate, it is attached to the end of the file. In addition, a table related to ASI-FM is given 
below as an example. 
 
 
 
5. Statistical Analysis of Data: 
As descriptive statistics in the study; Frequency (n) and percentage (%) values will be used in the 
evaluation of categorical variables. Shapiro-Wilk and Kolmogorov-Smirnov normality tests will be 
used for the conformity of numerical variables to the normal distribution, and as descriptive 
statistics; Mean±standard deviation values will be given for the variables suitable for normal 
distribution, and median (minimum-maximum) values will be given for those that do not comply 
with the normal distribution. The appropriate hypothesis testing method planned to be used in the 
study was determined as "Two-Way Analysis of Variance with Repetitions on a Single Factor" 
when parametric test assumptions were met. If the parametric test assumptions for the relevant test 
are not met, whether there is a difference between the groups in terms of quantitative variables, 
with the "Student t test" when the parametric test assumptions are met, and with the "Mann-Whitney 
test" if they are not; In examining whether quantitative variables change according to three separate 
evaluation times, "Repeated measures variance analysis" will be used when the test assumptions 
are met, and "Friedman test" if it is not provided. Type I error probability will be taken as α=0.05 
in all hypothesis tests and SPSS v25.0 package program will be used for statistical evaluations. 
While calculating the sample size required to test the research hypothesis, the effect widths defined 
by Cohen* were used and the calculations were made with the G*Power 3.1.9 program. 
 

The minimum sample size required for the study is 90 people in total, approximately equally 
distributed in the groups that will provide 90% test power at 95% confidence level, with the effect 
width f=0.30* for "Two-Way Analysis of Variance in Repeated Measurements with Repetitions on 
a Single Factor". 
 
F tests - ANOVA: Repeated measures, between factors 
 
Analysis: A priori: Compute required sample size  
Input: 
 
Effect size f                  = 
0,3 
 
 
 
α err prob                     = 
0,05 
 
 
 
Power (1-β err prob)           = 
0,9 
 
 
 
Number of groups               = 
2 
 
 
 
Number of measurements         
= 
2 
 
 
 
Corr among rep measures        
= 
0,5 
Output: 
 
Noncentrality parameter λ      
= 
10,8000000 
 
 
 
Critical F                     = 
3,9493210 
 
 
 
Numerator df                   
= 
1,0000000 
 
 
 
Denominator df                 
= 
88,0000000 
 
 
 
Total sample size              
= 
90 
 
 
 
Actual power                   
= 
0,9015268 
 
 
 
 
0,6
0,65
0,7
0,75
0,8
0,85
0,9
0,95
0
20
40
60
80
100
Total sample size
 = 0,3
Effect size f
F tests - ANOVA: Repeated measures, between factors
Number of groups = 2, Number of measurements = 2, Corr among rep measures = 0,5, α err prob = 
0,05, Effect size f = 0,3
Power (1-β err prob)

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Turner-Stokes L. Goal attainment scaling (GAS) in rehabilitation: a practical guide. Clinical 
rehabilitation. 2009;23(4):362-70. 

41. 
May-Benson TA, Roley SS, Mailloux Z, Parham LD, Koomar J, Schaaf RC, et al. Interrater 
reliability and discriminative validity of the structural elements of the Ayres Sensory Integration® 
Fidelity Measure©. The American Journal of Occupational Therapy. 2014;68(5):506-13. 
7. Ayres Sensory Integration Certificate 
 
8. Investigator: 
Büşra KAPLAN, MSc., OTR/L 
Gonca BUMİN, Prof. Dr., Occupational Therapy 
Hakan ÖĞÜTLÜ, Ass. Prof., Child Psychiatry 
Mehmet Hakan TÜRKÇAPAR, Prof. Dr., Psyschiatry 
 
 
 
               
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Certi es that
Büşra Kaplan
Has Completed the Requirements for the
Certi cate in Ayres Sensory Integration ®
Including advanced training in the administration, scoring and interpretation of the comprehensive measures of sensory integration,
including the EASI, SIPT & SPM.
CLASI CASI #2007
Susanne Smith Roley, OTD, OTR, FAOTA
Zoe Mailloux, OTD, OTR/L, FAOTA
Co-Founder, CLASI
Co-Founder, CLASI
Issue Date: January 2023