Clinical trial NCT07004036: The Effects Of Occupation-Based Self-Regulation Program On Sensory Processing, Executive Functions and Occupational Performance In Preschool Children With Screen Addiction
Official title: The Effects Of Occupation-Based Self-Regulation Program On Sensory Processing, Executive Functions and Occupational Performance In Preschool Children With Screen Addiction
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Screen Time Exposure
Keywords: Screen Time Exposure
Executive Function
Self-control
Sensory Processing
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 20
Sex: ALL
Minimum age (years): 48
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will receive one-time family training on screen addiction and its harms, while the other group will receive a self-regulation intervention program in addition to family training.
Primary purpose: TREATMENT

Brief summary: The purpose of this interventional study was to measure the effectiveness of a self-regulation program for screen addiction in preschool children aged 4-5 years. The main questions it aimed to answer were:

Does a self-regulation intervention program reduce screen addiction in preschool children? Does a self-regulation intervention program improve self-regulation skills in preschool children? Does a self-regulation intervention program improve sensory processing skills in preschool children? Does a self-regulation intervention program improve reading performance in preschool children?

Detailed description: Time spent using screen-based media devices is present in every aspect of the lives of twenty-first-century children and adults. Rapid technological advances and the marketing of portable screen-based devices such as smartphones and tablets to consumers around the world have changed the way and duration of people interacting with electronic media. As our society becomes more technologically dependent, the health effects of high levels of sedentary screen time, especially among children and adolescents, need to be given more attention. Defined as time spent watching television, DVDs, or videos or playing computer or video games, screen time has been linked to serious health outcomes in children, including impaired language acquisition, violent behavior, tobacco smoking, and obesity. In 2001, the American Academy of Pediatrics recommended that children under 2 should not spend time in front of a screen at all, limited it to one hour per day from age 2 to age 5, and recommended a two-hour limit for daily screen time for non-school and/or non-work activities after age 5, and today offers a general recommendation to limit screen time. Despite these recommendations, the time spent in front of screens has been increasing day by day, while the age of use has decreased from 4 years to 4 months since the 1970s.

The term "screen addiction" is increasingly used to describe the increasing number of children who engage in various screen activities in a dependent and problematic manner. The concept and diagnostic criteria are derived from criteria for pathological gambling and substance-related addiction and are generally based on the amount of time spent on a screen activity, such as playing the computer, and the extent to which it compromises the individual's overall functioning. Similar to other addictions, the diagnostic criteria include preoccupation, withdrawal symptoms, increased tolerance, failure to reduce or stop screen activities, loss of other interests, continuation despite negative consequences, lying about the extent of use, and use to escape negative moods.

The main neurological interest has focused on the problematic use of internet and computer games. However, although there is currently a degree of interchangeability and overlap between some diagnostic and diagnostic terms, the lack of standardization in concepts and terminology is considered a major obstacle to advancing this area of research and treatment, and steps are being taken to achieve greater consensus on terminology. Therefore, addictions such as internet addiction disorder, internet gaming disorder, problematic internet use, compulsive internet use, pathological video game use, video game addiction, pathological technology use, online gaming disorder, mobile phone addiction, social networking addiction, Facebook addiction, internet pornography addiction are all considered screen addiction disorders. There is a steady increase in young people's digital media consumption in most Western and some Far Eastern countries. In 2011, 52% of children aged 0-8 had access to a mobile device. This access increased to 75% by 2013 (8). In 1999, the average screen time of 8-18 year olds was 6.21 hours per day and increased to 7.38 hours in 2009. A self-reported study of screen time habits shows that British children and adolescents (8-18) spend an average of 4 hours and 45 minutes per day in front of a screen, either as a main activity or when engaged in other activities. Furthermore, the results from the same study show a significant increase in screen time among British children from 2010 to 2015. In most age groups in North America, there has been a significant increase in computer use in leisure time from 2001 to 2016. According to a 2018 survey of 3660 school children in Denmark, 24% of boys and 19% of girls aged 13-15 watch at least four hours of movies, TV series, YouTube films or entertainment programs per weekday. A study of more than 2,000 U.S. children ages 8 to 18 found that 21% typically watched more than 16 hours of media content in a 24-hour period, 63% watched 3 to 16 hours, and only 17% watched less than 3 hours. In addition, the International Child Accelerometer Database found that in a sample of 11,434 children ages 4 to 17, at least two-thirds had more than 2 hours of screen time. These findings suggest that an alarming number of children and adolescents are engaging in excessive sedentary screen time, leading to a range of adverse health outcomes.

Preschool children who spend 1 hour or more per day in early childhood and 2 hours or more per day after the age of 5 may experience a number of negative problems related to child health and well-being. Many problems such as unhealthy eating patterns, obesity, poor sleep quality, orthopedic problems, cardiovascular diseases, increased emotion dysregulation, decreased prosocial behaviors, increased inattention and hyperactivity, lower language skills, executive dysfunction, cognitive problems, and disruptions in the parent-child relationship, including reading books together, have been associated with increased screen time. However, childhood is a period when there are significantly greater changes in the anatomical structure and connectivity of the brain. It has been suggested that screen addiction disorder, and even intensive exposure to screens such as intensive video game play during childhood, may lead to neuroadaptations and structural changes in neural regions associated with addiction. In a study of 248 healthy children aged 5-17, Takeuchi et al. They reported significant correlations between average daily video game playing hours over a 3-year period and microstructural changes that reflected a decrease in tissue density. These changes were uniquely susceptible to neural plasticity, particularly within the dopaminergic system. Consequently, increased video gaming is directly and indirectly associated with delayed microstructural development in large brain regions. Conditions in which children play video games for long periods of time may lead to adverse neurocognitive development. These brain regions are often the same brain regions implicated in gambling disorders and substance abuse studies. The development and maintenance of video game addiction is increasingly viewed as a maladaptive interaction between neurological structures and functions underlying important components of addiction: reward, pleasure, craving, reinforcement, learning, memory, impaired executive functions, inhibitory control, decision making, and emotion management. Much of the neurological research on video game addiction has focused on dysfunctional interactions between neurological structures involved in executive control and reward seeking. Structural differences between subjects with and without SAD have been reported in additional brain regions, such as prefrontal and limbic structures in both gray and white matter. Functional brain correlates of SAD are also found in the prefrontal cortex and limbic structures. The typical features of impaired executive function and inhibitory control in addiction are related to low functional connectivity in fronto-striatal circuits. Changes in dopaminergic systems related to reinforcement/reward processing have also been suggested. Recent whole-brain functional connectivity analyses in SAD subjects have indicated that there are predominantly impaired connections in frontal areas, representing changes underlying different aspects of cognitive control. Interestingly, impairments similar to clinical cases have been shown in the preclinical stages of Internet addiction. However, the authors state that 'the interregional connections associated with Internet addiction tendencies replicate those frequently seen in the substance addiction literature'. In the study conducted by Wang et al., compared to the control group, subjects with internet gaming disorder had increased functional connectivity problems in the prefrontal cortex, left posterior cingulate cortex, right amygdala and bilateral lingual gyrus, and sensory-motor brain networks, along with functional connectivity disorders including impaired executive control and emotional management.

Since sensory-perceptual abnormalities are manifestations of disorders in the interactions of the neocortex, basal ganglia, and cerebellum, they are likely to coexist with abnormalities in motor function, cognitive and communication deficits, and social functioning. This is because sensory processing abnormalities are subtle indicators of deficits in "executive control," broadly defined. This is because sensory processing skills are more apparent in the developing brain, where they can be diagnosed earlier than more complex executive control can be measured, and executive control can be measured later when conditions are favorable. The development of working memory functions depends on inhibitory control. In the absence of inhibitory capacity to sustain focused attention, thought-guided behavior is inhibited. Deficits in cognitive abilities, emotional control, academic skill sets, and even communication and social competence can all be predicted based on the regions and extent of pathology in brain systems that mediate choice and regulation. In this context, early detection of hypo and/or hypersensitivity and responsiveness may enable the development of treatment approaches that increase compliance in various functional areas.

In a study conducted to define the relationship between the time children spend in front of the screen and sensory processing skills, a significant and negative relationship was found specifically between visual, tactile, body awareness, balance, planning and general sensory processing skills. It has been stated that in connection with the increased screen exposure time of children at an early age, there are problems such as "decreased cognitive abilities, poor school performance, slowed growth, development of addictive behavior, poor sleep patterns and increased obesity levels" which can be said to be related to sensory processing problems.

If the sensory processing system does not provide reliable information, sensory processing disorder may occur. In this case, the person's organizational, motor, attention, self-care, auditory and visual skills are negatively affected and the individual may not feel safe.

Although the development of executive functions has its roots in infancy, it begins to develop at approximately 4 years of age. Executive functions such as task persistence, impulse control, emotion regulation, and creativity and cognitive flexibility are affected by child-led play as well as positive parenting. Recent studies have shown associations between media use in childhood and poorer executive function. These studies suggest that earlier age at which media use begins and higher cumulative hours of media use are important independent predictors of poor executive function. This association has been attributed to the stimulating and fast-paced content of some children's schedules and the displacement of other enriching activities or the time when the brain is not functionally engaged. Media multitasking, which is associated with executive function deficits in young adults, has now been documented in children as young as 4 years old.

Screen addiction disorder, which has been shown to have executive function deficits and sensory processing deficits, also has speech organization problems in children with screen addiction-intense screen time.

Preschool children have cognitive developmental problems or sensory processing problems, along with accompanying problems in participation in activities of daily living, leisure time, and play. Studies have shown that activity participation and activity performance are affected in children with sensory processing problems, cognitive problems, especially executive dysfunctions, attention deficit and hyperactivity disorder, or various disorders such as autism spectrum disorder. Occupational performance is a dynamic process that covers the entirety of an individual's daily life activities and is affected by many factors such as physical, cognitive, emotional, environmental and social patterns. Studies have suggested that the situation defined as nomophobia, which is defined as the fear of being away from a mobile phone, has a negative effect on ADL because it causes problems in cognitive, emotional, physical and social functions. The concept of self-regulation, which is extremely important for children to be able to regulate their cognitions, emotions and behaviors on their own, to be ready for school, and to be successful in school and in their future lives, is described in the literature as a broad term that includes planning and executive skills (especially working memory, cognitive flexibility and inhibitory control) as top-down and regulation of reactive impulses as bottom-up.

Eligibility criteria: Inclusion Criteria:

* Children between 48-59 months of age
* Who do not have any additional diagnosis
* Spend 2 hours or more on screens per day and
* Attend kindergarten will be included.

Exclusion Criteria:

* Have any diagnosed disorder that may cause sensory processing disorder or executive function disorder,
* Have any diagnosed disorder that may lead to limitation of occupational performance, or
* Individuals who have not attended kindergarten will not be included in the study.

Primary outcomes:
measure: Screen Time
timeFrame: The average daily screen time for one week at the beginning of the study and the average daily screen time for one week at the end will be measured.
measure: Sensory Processing
timeFrame: Both assessments will take 15 minutes each, one at the beginning of the study, the day before the intervention, and one at the end of the study, the day after the intervention.
measure: Executive Function/Self Regulation
timeFrame: Both assessments will take 30 minutes each, one at the beginning of the study, the day before the intervention, and one at the end of the study, the day after the intervention.
measure: Occupational Performance
timeFrame: Both assessments will take 10 minutes each, one at the beginning of the study, the day before the intervention, and one at the end of the study, the day after the intervention.
measure: Problematic Media Use
timeFrame: Both assessments will take 5 minutes each, one at the beginning of the study, the day before the intervention, and one at the end of the study, the day after the intervention.
measure: Occupational Profile
timeFrame: Both assessments will take 10 minutes each, one at the beginning of the study, the day before the intervention, and one at the end of the study, the day after the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Health Sciences University
Study officials:
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