Early InterventionNCT05880238
The Effect of Sensory Motor Training in Preschool Children
A study testing Intervention group in people with Early Intervention, run by Biruni University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Intervention
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 May 2023to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- to attend preschool education class
- to be between the ages of 5-6
- not to have started primary school yet
Who cannot join
- to have a neurological, orthopedic, or psychiatric diagnosis,
- to have a sensory disability (e.g. visual and hearing loss).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Occupational Therapy-Based Sensory Motor Training On Self-Regulation, Cognitive Skills, And School Readiness in Preschool Children
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.
Read more
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.
Read the detailed 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.
- Conditions
- Early Intervention
- Being tested
- Intervention group, Control group
- Keywords
- pre-school, sensory-motor, self-regulation, school readiness
- Medical subject headings
- Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
The intervention consisted of a total of 3 modules, 20 sessions. These modules are: Module A: I explore my inner and outer world Module B: I am learning self-editing methods C module: discovering self-editing In these modules, students were trained to use sensorimotor strategies for self-regulation. The intervention program was carried out in one-hour sessions, twice a week, for a total of 10 weeks.
Control groupOther
The control group will continue their education according to the preschool education curriculum.
| Study group | Role | What they receive |
|---|---|---|
| Sensory-motor training | Experimental | The study group received group interventions that included self-regulation strategies and sensory-motor skill training in addition to preschool education. Group interventions were conducted with groups of up to 10 participants for a total of one hour, twice a week for 10 weeks. Receives: Behavioral: Intervention group |
| Control | Active comparator | The control group continued with preschool education and did not receive any additional intervention. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Metropolitan School Readiness Test
The Metropolitan School Readiness Test was developed by G. H. Hildreth, N. L. Griffits, and M. Mc Gauvran in 1949. This test was adapted into Turkish by Oktay (1980) and is used to measure the characteristics and levels of school readiness for 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 meaning (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). Higher scores indicate higher performance.
Measured: two weeks
Kansas Reflection-Impulsivity for Preschool-KRISP
The scale used to determine the cognitive tempo of children is the Form A of the Kansas Reflection-Impulsivity for Preschool-KRISP developed by Wright (1971). The scale consists of 10 shapes and 5 sample shapes that will be used to teach children how to use the scale. Higher scores indicate higher performance.
Measured: one week
Childhood Executive Functioning Invantery-CHEXI
The measurement tool developed by Thorell and Nyberg (2008) focuses on the executive functions of children aged 4-12 years old. The questions in the scale were created based on Barkley's (1997) model, which explains that inhibitory control, working memory, and self-regulation create significant executive function impairments in children with ADHD. The lover scores indicate higher performance.
Measured: one week
Preschool Self-Regulation Scale
The Preschool Self-Regulation Assessment (PSRA), developed by Smith-Donald et al. (2007), is a performance-based assessment tool that enables evaluators to assess children's emotions, attention, and behaviors based on practitioner-child interactions. The Practitioner Rating Form in the PSRA is a rubric-style assessment tool that is scored from 0 to 3 based on the items used. The Turkish adaptation of the PSRA was carried out by Ezgi Fındık Tanrıbuyurdu and Güler Yıldız in 2012 (Tanrubuyurdu and Yıldız, 2012). The higher scores indicate higher performance.
Measured: two weeks
Secondary outcomes (2)
Sensory Profile
The Sensory Profile, developed by Occupational Therapist Prof. Winnie Dunn, is a measurement tool used to evaluate an individual's sensory modulation, or in other words, their tendency to respond to sensory stimuli during daily activities and which sensory systems are most affected. The validity and reliability of this test have been shown. The test is used to measure an individual's functional performance in daily life activities, sensory processing abilities, and sensory processing impact. It consists of three main sub-parameters (sensory processing, modulation, and behavioral-emotional responses) and nine factor scores composed of a Likert scale (1 = Always, 2 = Often, 3 = Sometimes, 4 = Rarely, 5 = Never). Typical performance, potential differences, and definitive difference score ranges have been established for each parameter. As the total score for each parameter approaches the typical performance score range from the definitive difference score range, improvement is seen.
Measured: one week
Bruininks-Oseretsky Test 2 Short Form
The BOT2-KF consists of a total of 8 subtests and 12 items. The administration of the test takes approximately 15-20 minutes. A person can receive a maximum of 72 processed points from the test. The validity and reliability study of the test has been conducted in Turkish (Köse et al., 2021).
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start17 May 2023
- Primary completion18 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early InterventionStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Remziye Akarsu, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880238
- Sponsor's protocol ID
- pre-school intervention
- Status last verified
- Sep 2023
- First submitted
- 17 May 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Occupational Therapy-Based Sensory Motor Training On Self-Regulation, Cognitive Skills, And School Readiness in Preschool Children
- ClinicalTrials.gov ID
- NCT05880238
- Acronym / sponsor ID
- pre-school intervention
- Conditions
- Early Intervention
- Keywords
- pre-school, sensory-motor, self-regulation, school readiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 17 May 2023 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensory-motor training | Experimental | Behavioral: Intervention groupThe study group received group interventions that included self-regulation strategies and sensory-motor skill training in addition to preschool education. Group interventions were conducted with groups of up to 10 participants for a total of one hour, twice a week for 10 weeks. |
| Control | Active comparator | Other: Control groupThe control group continued with preschool education and did not receive any additional intervention. |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- to attend preschool education class
- to be between the ages of 5-6
- not to have started primary school yet
Key exclusion criteria (2 listed)
- to have a neurological, orthopedic, or psychiatric diagnosis,
- to have a sensory disability (e.g. visual and hearing loss).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupThe intervention consisted of a total of 3 modules, 20 sessions. These modules are: Module A: I explore my inner and outer world Module B: I am learning self-editing methods C module: discovering self-editing In these modules, students were trained to use sensorimotor strategies for self-regulation. The intervention program was carried out in one-hour sessions, twice a week, for a total of 10 weeks. | Behavioural | Sensory-motor training |
| Control groupThe control group will continue their education according to the preschool education curriculum. | Other | Control |
Primary outcome
The Metropolitan School Readiness Test
Time frame: two weeks
The Metropolitan School Readiness Test was developed by G. H. Hildreth, N. L. Griffits, and M. Mc Gauvran in 1949. This test was adapted into Turkish by Oktay (1980) and is used to measure the characteristics and levels of school readiness for 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 meaning (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). Higher scores indicate higher performance.
Kansas Reflection-Impulsivity for Preschool-KRISP
Time frame: one week
The scale used to determine the cognitive tempo of children is the Form A of the Kansas Reflection-Impulsivity for Preschool-KRISP developed by Wright (1971). The scale consists of 10 shapes and 5 sample shapes that will be used to teach children how to use the scale. Higher scores indicate higher performance.
Childhood Executive Functioning Invantery-CHEXI
Time frame: one week
The measurement tool developed by Thorell and Nyberg (2008) focuses on the executive functions of children aged 4-12 years old. The questions in the scale were created based on Barkley's (1997) model, which explains that inhibitory control, working memory, and self-regulation create significant executive function impairments in children with ADHD. The lover scores indicate higher performance.
Preschool Self-Regulation Scale
Time frame: two weeks
The Preschool Self-Regulation Assessment (PSRA), developed by Smith-Donald et al. (2007), is a performance-based assessment tool that enables evaluators to assess children's emotions, attention, and behaviors based on practitioner-child interactions. The Practitioner Rating Form in the PSRA is a rubric-style assessment tool that is scored from 0 to 3 based on the items used. The Turkish adaptation of the PSRA was carried out by Ezgi Fındık Tanrıbuyurdu and Güler Yıldız in 2012 (Tanrubuyurdu and Yıldız, 2012). The higher scores indicate higher performance.
2 secondary outcomes
Sensory Profile
Time frame: one week
Bruininks-Oseretsky Test 2 Short Form
Time frame: two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Early Intervention, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Metropolitan School Readiness Test (time frame: two weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.