Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05880238 |
| Other study ID # |
pre-school intervention |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 17, 2023 |
| Est. completion date |
September 1, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Biruni University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
When looking at the literature, sensory-motor skills, self-regulation, executive functions,
cognitive styles, and school readiness are strongly related concepts. Self-regulation skills
are closely related to the maturity of sensory-motor components. Therefore, it is important
to provide sensory-motor training with self-regulation strategies. However, no study
investigating the effects of self-regulation strategies combined with sensory-motor training
on school readiness, self-regulation, executive functions, and cognitive styles could be
found in the literature.
Our study aims to examine the effect of self-regulation strategies and occupational
therapy-based sensory-motor training on self-regulation, cognitive skills, and school
readiness in preschool children.
The research will be carried out in two preschool classrooms of students aged 5-6 years
registered for the 2022-2023 academic year at Özel Mavi Umut Eğitim Kurumları in Istanbul.
A total of 38 children will participate in the study, 19 in the intervention group and 19 in
the control group. While the control group continues their preschool education, the
intervention group will receive group interventions including self-regulation strategies and
sensory-motor skills training for 1 hour, twice a week, for 10 weeks, in addition to their
regular preschool education.
Metropolitan School Readiness Test, Kansas Pre-School Self-Concept Scale Form A, Childhood
Executive Function Inventory, Pre-School Self-Regulation Scale, Dunn Sensory Profile, and
Bruininks-Oseretsky Short Form 2 will use to evaluate both the intervention and control
groups at 10-week intervals.
The data obtained from the evaluations will be analyzed using SPSS (Statistical Package for
Social Science) 22.0 version. If the data follows a normal distribution, the Paired Student's
t-test will be used for comparison, and if not, the Wilcoxon Matched Two-Sample Test will be
used. Mean±standard deviation (X±SD) will be determined for the identified variables. A
statistical significance level of p≤0.05 will be considered.
Description:
The purpose of our study is to investigate the effect of self-regulation strategies and
occupational therapy-based sensory-motor education on self-regulation, cognitive skills, and
school readiness in preschool children.
The research will be carried out in two kindergarten classes consisting of students aged 5-6
years, registered as part of the 2022-2023 academic year at Özel Mavi Umut Eğitim Kurumları
located in Istanbul. In the G-Power program, based on the literature information, it was
calculated that at least 15 people should participate in the study for each group,
considering the values of 1.33±1.27 (mean±SD difference between groups) for 95% power
(Fathirezaie et al., 2021). A total of 38 children, including 19 children whom will receive
self-regulation strategies and a sensory-motor education program in the study group and 19
children in the control group, will include in the study.
To sustain the experimental study, an easily accessible preschool institution was selected.
Kindergarten classes at Özel Mavi Umut Eğitim Kurumları will determine as the study and
control group using a simple random sampling method.
While the control group continues preschool education, group interventions, including
self-regulation strategies and sensory-motor skill training, will be applied to the study
group in addition to preschool education. Group interventions will be conducted twice a week
for a total of one hour for 10 weeks, with groups consisting of up to 10 people.
The inclusion criteria were attending preschool education, being between the ages of 5-6, and
not having started primary school. Children with neurological, orthopedic, psychiatric
diagnoses, and sensory impairments (e.g. visual and hearing loss) were excluded from the
study.
EVALUATION TOOLS Parent-child information form (including questions that comply with
inclusion criteria and general demographic information such as body mass index and education)
Primary outcome measures
Metropolitan School Readiness Test: Developed by G.H. Hildreth, N.L. Griffiths, and M. Mc
Gauvran in 1949, this test was adapted into Turkish by Oktay (1980) and is used to measure
the characteristics that determine the school readiness and the level of school readiness of
children who are starting school. The test consists of two sub-dimensions: reading readiness
and number readiness, and a total of 100 items. The reading readiness sub-dimension consists
of 66 items, including word comprehension (19), sentences (14), general knowledge (14), and
matching (19). The number readiness sub-dimension consists of 34 items, including numbers
(24) and copying (10) (Oktay, 1983, p. 35). In the reliability study carried out within this
scope, the correlations between parallel forms applied at certain intervals to 195
first-grade students were calculated, and the reliability coefficients obtained were found to
range from .53 to .83. American norms and Istanbul norms were compared for the validity of
the test. In the study, the test was applied to children living in certain regions of
Istanbul and compared with the American norms.
The Kansas Reflection-Impulsivity Scale for Preschool Children A Form (KRISP) is a scale
developed by Wright (1971) to determine children's cognitive tempo. The scale consists of 10
shapes and 5 example shapes that will be used to teach children how to apply the scale. The
validity and reliability studies of the scale were conducted by Seçer et al. (2010). For the
scope and face validity of the scale, expert opinions were obtained. For reliability studies,
scorer reliability, test-retest, and split-half reliability were preferred. For scorer
reliability, 30 six-year-old students were evaluated by two different observers for response
time. The correlation between the two observers was found to be r = 0.83 for response time
and r = 0.78 for error rate. Test-retest reliability was examined by selecting a study group
of 303 children attending preschool education institutions in the center of Konya and
applying the scale twice with a two-week interval, and Pearson's Moment Correlation
Coefficient was examined between application scores. The correlation coefficient was r = 0.74
for error rate and r = 0.89 for response time. There was a positive, significant (p <.01)
relationship between the two separate applications in the same group. As a result of the
findings, it was concluded that the consistency between the two applications of the scale was
at an acceptable level. To determine the reliability of the test, the split-half method was
also used. The correlation coefficient calculated using the Spearman-Brown formula for
response time was r = 0.85, and for error rate was r = 0.71 (Seçer et al., 2010).
The scale is applied one-on-one with the child by the researcher. Before the application, the
researcher prepares a note paper where the child's information will be recorded, and the
child is taught how to apply the scale using the five example shapes available in the scale.
Once the child has learned how to apply the scale, the actual shapes are shown to the child
one by one. Pages containing the actual shape and six pages with shapes that are almost
identical to the actual shape are shown to the child at the same time, and the child is asked
to find the same shape as the actual one among the other six shapes. The timer is started as
soon as the instruction is given to the child, and the child's first response time is
recorded on the prepared paper. If the answer is correct, the same process is repeated for
the other shapes, and if the answer is incorrect, another instruction is given to the child
to find the correct shape, and all answers are recorded. The number of mistakes the child
makes until finding the correct answer is also noted in this paper.
The Childhood Executive Functioning Inventory (CHEXI) is a measurement tool developed by
Thorell and Nyberg (2008) that focuses on the executive functions of children aged 4-12. The
questions in the inventory were created based on Barkley's (1997) model, which explains that
inhibitory control, working memory, and self-regulation create significant executive function
disorders in children with ADHD. Initially, 26 items were categorized into four
sub-dimensions. According to this, 11 items were considered "working memory," four items were
considered "planning," six items were considered "inhibitory control," and five items were
considered "regulation." However, items 25 and 26 were not included in the factor analysis
due to very low sample suitability. According to the results of the factor analysis, a
two-factor structure provided the best fit to the data: (1) working memory and (2) inhibitory
control. The first factor includes the items of working memory and planning sub-dimensions,
while the second factor includes the items of inhibitory control and regulation
sub-dimensions. In addition, the correlation between the two factors was found to be 0.65.
All of these analyses were first performed for the parental form of the inventory. In the
study conducted with the teacher form, a two-factor structure also emerged. In teacher
evaluations, the correlation between the two factors was found to be 0.69 (Thorell and
Nyberg, 2008). As a result, the CDYIE consists of 24 items. Working Memory contains 13 items
(e.g., "Has difficulty remembering what they were doing in the middle of an activity"), while
Inhibitory Control contains 11 items (e.g., "Has difficulty restraining or controlling
oneself even when told to do so"). The scale can be completed by parents or teachers. The
scale is a 5-point Likert scale. After each statement, the parent or teacher indicates how
true the statement is for the child by circling one of the numbers (1 to 5) provided (1: Not
true, 5: True). Filling out the scale takes 5-10 minutes (Thorell and Catale, 2014; Thorell
and Nyberg, 2008). High scores on the scale indicate that the child has more difficulties
related to executive functions. Therefore, it can be interpreted that children who score
lower on the inventory have higher levels of executive functions than those who score higher
(Thorell and Nyberg, 2008). However, in this study, all items were reverse-coded to represent
an increase in executive function skills rather than difficulties, so higher scores indicate
that the child shows more executive function skills.
Secondary Outcome Measures
Dunn Sensory Profile: Sensory Profile, developed by Occupational Therapist Prof. Winnie Dunn,
is a measurement tool used to evaluate an individual's tendency to respond to sensory stimuli
during daily activities, also known as sensory modulation, and which sensory systems affect
daily life more. The validity and reliability of this test have been demonstrated. The test
is used to measure an individual's functional performance in daily life activities, sensory
processing abilities, and sensory processing impact, and is evaluated based on a Likert scale
(1 = Always, 2 = Often, 3 = Sometimes, 4 = Rarely, 5 = Never) with 9-factor scores consisting
of 3 main sub-parameters (sensory processing, modulation, and behavioral-emotional
responses). Typical performance, possible differences, and definite difference score ranges
have been determined for each parameter. As the total score for each parameter progresses
towards the typical performance score range from the definite difference score range,
improvement is observed (Dunn, 1999). The validity and reliability of the Sensory Profile
test have been established (Kayıhan et al., 2012).
Bruininks-Oseretsky Test 2 Short Form: The development of the Bruininks-Oseretsky Motor
Proficiency Test (BOMPT) began in 1972 by Robert H. Bruininks based on the Oseretsky Motor
Proficiency Test. After six years of work, Dr. Robert H. Bruininks developed the test
(Bruininks, 2005; Crowe, 1989). The BOMPT was developed to measure the motor functions of
children aged 4.5-14 years. The long form of the BOMPT consists of 8 sub-tests and a total of
46 items. It is also a comprehensive motor proficiency indicator and measures both gross and
fine motor skills. In 2005, the Bruininks-Oseretsky Motor Proficiency Test was updated and
became the Bruininks-Oseretsky Test 2 (BOT2). BOT2 applies to children aged 4-21 years. The
validity and reliability of BOT2 long form were tested on healthy children aged 5 years by
Ballı in 2012 (Ballı and Gürsoy, 2012; Bruininks and Oseretsky, 2010). BOT2-KF was updated in
2010. BOT2-KF consists of 8 sub-tests and 12 items in total. The test takes about 15-20
minutes to administer. A person can obtain a maximum of 72 processed points from the test. A
Turkish validity and reliability study has been conducted (Köse et al., 2021).
INTERVENTION PROGRAM The study will be conducted as a group intervention for 10 weeks, with
each training session lasting one hour, twice a week. The group intervention will be
implemented with 10 children in each group.
The control group will continue their preschool education, and the same evaluations will be
applied to this group at a 10-week interval.
Existing programs in the literature on self-regulation strategies and sensory-motor education
planning will be used in the content of the program.
Assessment tools will be applied to the study and control group children at a 10-week
interval. The data obtained from the evaluation will be analyzed using the SPSS (Statistical
Package for Social Science) 22.0 version. After checking whether the data conforms to a
normal distribution with the Shapiro-Wilk test, if the data is normally distributed, the
paired samples Student's t-test will be used for statistical comparison, and if not, the
Wilcoxon Matched-Pairs Two-Sample Test will be used. Mean±standard deviation (X±SS) will be
determined for the identified variables. A significance level of p≤0.05 will be accepted for
statistical significance.
