Screen Time ExposureNCT07004036
The Effects Of Occupation-Based Self-Regulation Program On Sensory Processing, Executive Functions and Occupational Performance In Preschool Children With Screen Addiction
A study testing Occupation-based Self-Regulation Intervention Program and Family Awareness Training in people with Screen Time Exposure, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 48 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Screen Time Exposure
- What is being tested?
- Occupation-based Self-Regulation Intervention Program and Family Awareness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Mar 2025to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 48 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read the 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.
- Conditions
- Screen Time Exposure
- Being tested
- Occupation-based Self-Regulation Intervention Program, Family Awareness Training
- Keywords
- Screen Time Exposure, Executive Function, Self-control, Sensory Processing
- Medical subject headings
- Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupation-based Self-Regulation Intervention ProgramBehavioural
The intervention includes both group and individual applications. It has a large occupation/activity pool that can be selected in a person-centered manner. The activities are focused on supporting and developing the areas of influence in the sensory processing skills of individuals or the areas in executive functions, and providing occupations that will replace the screen and shape life in children for the screen abuse. It shapes the will, habits and routines necessary for the child to prefer alternative activities instead of the screen. For this purpose, an intervention program has been shaped to ensure that the child gains in the areas of daily life activities, productivity activities and leisure activities with the right developing skills, the child's wishes, the family's wishes, social expectations. As far as we know, it is the first flood regulation intervention program applied to children with screen addiction from an occupational therapy perspective.
Family Awareness TrainingBehavioural
Family awareness training on the harms of screen addiction and prolonged exposure to the screen, as a one-time event.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | All 20 children participating in the study are individuals who have more than 2 hours of screen time per day. The individuals in the study do not have any known diagnosis that affects their self-regulation skills. Both their families and themselves are participating in the study voluntarily. They are randomly divided into two groups of 10 people. Each arm consists of 10 individuals. This is an intervention program that will be applied to the individuals in this arm for 8 weeks regarding self-regulation skills. During these eight weeks, one session per week will be applied in groups and one session will be applied individually. The intervention will include sensory processing skills and executive function skills. In addition, awareness training was provided to the families of the participants in this arm about the effects and harms of screen addiction. Receives: Behavioral: Occupation-based Self-Regulation Intervention Program |
| Control Group | Other | All 20 children participating in the study were individuals who had more than 2 hours of screen time per day. The individuals in the study did not have any known diagnosis that affected their self-regulation skills. Both their families and themselves participated in the study voluntarily. They were randomly divided into two groups of 10 people. Each arm consisted of 10 individuals. Awareness training was provided to the families of the participants in this arm about the effects and harms of screen addiction. Receives: Behavioral: Family Awareness Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screen Time
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.
Measured: 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.
Sensory Processing
The Dunn Sensory Profile was developed to assess responses in children to a variety of common sensory experiences. Parents are asked to rate the frequency of responses in their children to 125 common experiences using a Likert scale format. These questions and responses are divided into eight categories: Auditory, Visual, Activity Level, Taste/Smell, Body Position, Movement, Touch, and Emotional/Social. The sensory profile was deemed appropriate for children ages 3-10 and was standardized on 1,200 children with and without disabilities. Content and construct validity have been established. Responses are summarized in six sensory processing domains (Auditory Processing, Visual Processing, Vestibular Processing, Tactile Processing, Multisensory Processing, Oral Sensory Processing), five modulation processes, and three behavioral and emotional responses domains. The validity and reliability studies of the scale in Turkish.
Measured: 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.
Executive Function/Self Regulation
The scale consists of 3 levels of applications. At the first level, the child is asked to touch his feet when he is told to "touch his head" and to touch his head when he is told to "touch his feet". If he is successful at this level, he is asked to touch his shoulders when he is told to "touch his knee" and to touch his knees when he is told to "touch his shoulder". If he is successful at this level, he is asked to touch his knees when he is told to "touch his head", to touch his shoulders when he is told to "touch his feet", to touch his feet when he is told to "touch his shoulder" and to touch his head when he is told to "touch his knees". If he can do the given command without any mistakes, he is given 2 points, if he is oriented towards the wrong and does it correctly, he is given 1 point and if he gives the wrong answer, he is given 0 points. A total score of 0-60 is given with 10 applications at each level. As the score increases, the self-regulation score will increase.
Measured: 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.
Occupational Performance
The Canadian Occupational Performance Measure (COPM) is a general questionnaire based on a semistructured interview. The semistructured design allows individuals to identify important occupations that they have difficulty performing. COPM is derived from the Canadian Activity Performance Model, which defines occupational performance as the ability to organize, select, and perform meaningful occupations that are culturally defined and age-appropriate for taking care of oneself, enjoying life, building the economic fabric of society, and contributing to the social world. The fifth version of the COPM was published in 2014 and its Turkish adaptation has been made.
Measured: 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.
Problematic Media Use
It was developed to determine problematic media use in children between the ages of 4 and 11. The items of the scale were created by taking into account the Internet Gaming Disorder criteria expressed in DSM V. The scale consists of a 27-item form. The scale is Likert-type and each item is scored between 1 (never) and 5 (always). The total score obtained from the Problematic Media Use Scale is calculated by averaging the scores obtained from all items. High scores obtained from the scale indicate problematic use. While the scale, which is filled out by parents considering the child's behavior, does not provide information on the problematic use of a specific media tool, it tries to determine the problematic use of visual media tools (such as phones, tablets, computers, televisions) in general, in other words, screen addiction.
Measured: 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.
Occupational Profile
This assessment tool comprises 25 items organized into six sections. The initial five sections (volition, habituation, communication \& interaction skills, process skills, motor skills) evaluate the child's personal attributes and their influence on participation and performance in various activities. The final section investigates the impact of the environment on the child's capacity to engage in and perform these activities.
A four-point ordinal scale is employed for scoring individual items, using the following codes:
F = Facilitates A = Allows I = Inhibits R = Restricts participation
Numerical values are assigned to each code, ranging from 4 to 0. Specifically, 'F' is assigned a value of 4, 'A' is 3, 'I' is 2, and 'R' is 1.
The item scores are summed, yielding a maximum total score of 100 for the entire assessment. The minimum score is 25.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start21 Mar 2025
- Primary completion1 Apr 2025
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Screen Time ExposureStudies of the same condition, open and under way.
- 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
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Tekeci, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004036
- Sponsor's protocol ID
- 2023/84-2023080
- Status last verified
- Jun 2025
- First submitted
- 18 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Argumosa-Villar L, Boada-Grau J, Vigil-Colet A. Exploratory investigation of theoretical predictors of nomophobia using the Mobile Phone Involvement Questionnaire (MPIQ). J Adolesc. 2017 Apr;56:127-135. doi: 10.1016/j.adolescence.2017.02.003. Epub 2017 Feb 21.
PubMed 28231484Carswell A, McColl MA, Baptiste S, Law M, Polatajko H, Pollock N. The Canadian Occupational Performance Measure: a research and clinical literature review. Can J Occup Ther. 2004 Oct;71(4):210-22. doi: 10.1177/000841740407100406.
PubMed 15586853Wennberg B, Janeslatt G, Gustafsson PA, Kjellberg A. Occupational performance goals and outcomes of time-related interventions for children with ADHD. Scand J Occup Ther. 2021 Feb;28(2):158-170. doi: 10.1080/11038128.2020.1820570. Epub 2020 Sep 21.
PubMed 32955952Mathews, S. B., Mozolic-Staunton, B., Jefford, E., & Salehi, N. (2020). Canadian Occupational Performance Measure and early intervention: A scoping review. Journal of Occupational Therapy, Schools, & Early Intervention, 13(4), 353-373.
Dadson P, Brown T, Stagnitti K. Relationship between screen-time and hand function, play and sensory processing in children without disabilities aged 4-7 years: A exploratory study. Aust Occup Ther J. 2020 Aug;67(4):297-308. doi: 10.1111/1440-1630.12650. Epub 2020 Jan 30.
PubMed 32003027Koziol LF, Budding DE, Chidekel D. Sensory integration, sensory processing, and sensory modulation disorders: putative functional neuroanatomic underpinnings. Cerebellum. 2011 Dec;10(4):770-92. doi: 10.1007/s12311-011-0288-8.
PubMed 21630084Wang L, Wu L, Lin X, Zhang Y, Zhou H, Du X, Dong G. Altered brain functional networks in people with Internet gaming disorder: Evidence from resting-state fMRI. Psychiatry Res Neuroimaging. 2016 Aug 30;254:156-63. doi: 10.1016/j.pscychresns.2016.07.001. Epub 2016 Jul 6.
PubMed 27447451Brand M, Young KS, Laier C, Wolfling K, Potenza MN. Integrating psychological and neurobiological considerations regarding the development and maintenance of specific Internet-use disorders: An Interaction of Person-Affect-Cognition-Execution (I-PACE) model. Neurosci Biobehav Rev. 2016 Dec;71:252-266. doi: 10.1016/j.neubiorev.2016.08.033. Epub 2016 Aug 30.
PubMed 27590829Takeuchi H, Taki Y, Hashizume H, Asano K, Asano M, Sassa Y, Yokota S, Kotozaki Y, Nouchi R, Kawashima R. Impact of videogame play on the brain's microstructural properties: cross-sectional and longitudinal analyses. Mol Psychiatry. 2016 Dec;21(12):1781-1789. doi: 10.1038/mp.2015.193. Epub 2016 Jan 5.
PubMed 26728566Atkin AJ, Sharp SJ, Corder K, van Sluijs EM; International Children's Accelerometry Database (ICAD) Collaborators. Prevalence and correlates of screen time in youth: an international perspective. Am J Prev Med. 2014 Dec;47(6):803-7. doi: 10.1016/j.amepre.2014.07.043. Epub 2014 Sep 16.
PubMed 25241193Rasmussen M, Damsgaard MT, Morgen CS, Kierkegaard L, Toftager M, Rosenwein SV, Krolner RF, Due P, Holstein BE. Trends in social inequality in overweight and obesity among adolescents in Denmark 1998-2018. Int J Public Health. 2020 Jun;65(5):607-616. doi: 10.1007/s00038-020-01342-1. Epub 2020 Feb 20.
PubMed 32076738Yang L, Cao C, Kantor ED, Nguyen LH, Zheng X, Park Y, Giovannucci EL, Matthews CE, Colditz GA, Cao Y. Trends in Sedentary Behavior Among the US Population, 2001-2016. JAMA. 2019 Apr 23;321(16):1587-1597. doi: 10.1001/jama.2019.3636.
PubMed 31012934Magee CA, Lee JK, Vella SA. Bidirectional relationships between sleep duration and screen time in early childhood. JAMA Pediatr. 2014 May;168(5):465-70. doi: 10.1001/jamapediatrics.2013.4183.
PubMed 24589672Reid Chassiakos YL, Radesky J, Christakis D, Moreno MA, Cross C; COUNCIL ON COMMUNICATIONS AND MEDIA. Children and Adolescents and Digital Media. Pediatrics. 2016 Nov;138(5):e20162593. doi: 10.1542/peds.2016-2593.
PubMed 27940795Radesky JS, Christakis DA. Increased Screen Time: Implications for Early Childhood Development and Behavior. Pediatr Clin North Am. 2016 Oct;63(5):827-39. doi: 10.1016/j.pcl.2016.06.006.
PubMed 27565361
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Occupation-Based Self-Regulation Program On Sensory Processing, Executive Functions and Occupational Performance In Preschool Children With Screen Addiction
- ClinicalTrials.gov ID
- NCT07004036
- Acronym / sponsor ID
- 2023/84-2023080
- Conditions
- Screen Time Exposure
- Keywords
- Screen Time Exposure, Executive Function, Self-control, Sensory Processing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 4 Jun 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Occupation-based Self-Regulation Intervention ProgramAll 20 children participating in the study are individuals who have more than 2 hours of screen time per day. The individuals in the study do not have any known diagnosis that affects their self-regulation skills. Both their families and themselves are participating in the study voluntarily. They are randomly divided into two groups of 10 people. Each arm consists of 10 individuals. This is an intervention program that will be applied to the individuals in this arm for 8 weeks regarding self-regulation skills. During these eight weeks, one session per week will be applied in groups and one session will be applied individually. The intervention will include sensory processing skills and executive function skills. In addition, awareness training was provided to the families of the participants in this arm about the effects and harms of screen addiction. |
| Control Group | Other | Behavioral: Family Awareness TrainingAll 20 children participating in the study were individuals who had more than 2 hours of screen time per day. The individuals in the study did not have any known diagnosis that affected their self-regulation skills. Both their families and themselves participated in the study voluntarily. They were randomly divided into two groups of 10 people. Each arm consisted of 10 individuals. Awareness training was provided to the families of the participants in this arm about the effects and harms of screen addiction. |
Who may qualify
- Ages
- 48 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Occupation-based Self-Regulation Intervention ProgramThe intervention includes both group and individual applications. It has a large occupation/activity pool that can be selected in a person-centered manner. The activities are focused on supporting and developing the areas of influence in the sensory processing skills of individuals or the areas in executive functions, and providing occupations that will replace the screen and shape life in children for the screen abuse. It shapes the will, habits and routines necessary for the child to prefer alternative activities instead of the screen. For this purpose, an intervention program has been shaped to ensure that the child gains in the areas of daily life activities, productivity activities and leisure activities with the right developing skills, the child's wishes, the family's wishes, social expectations. As far as we know, it is the first flood regulation intervention program applied to children with screen addiction from an occupational therapy perspective. | Behavioural | Intervention Group |
| Family Awareness TrainingFamily awareness training on the harms of screen addiction and prolonged exposure to the screen, as a one-time event. | Behavioural | Control Group |
Primary outcome
Screen Time
Time frame: 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.
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.
Sensory Processing
Time frame: 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.
The Dunn Sensory Profile was developed to assess responses in children to a variety of common sensory experiences. Parents are asked to rate the frequency of responses in their children to 125 common experiences using a Likert scale format. These questions and responses are divided into eight categories: Auditory, Visual, Activity Level, Taste/Smell, Body Position, Movement, Touch, and Emotional/Social. The sensory profile was deemed appropriate for children ages 3-10 and was standardized on 1,200 children with and without disabilities. Content and construct validity have been established. Responses are summarized in six sensory processing domains (Auditory Processing, Visual Processing, Vestibular Processing, Tactile Processing, Multisensory Processing, Oral Sensory Processing), five modulation processes, and three behavioral and emotional responses domains. The validity and reliability studies of the scale in Turkish.
Executive Function/Self Regulation
Time frame: 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.
The scale consists of 3 levels of applications. At the first level, the child is asked to touch his feet when he is told to "touch his head" and to touch his head when he is told to "touch his feet". If he is successful at this level, he is asked to touch his shoulders when he is told to "touch his knee" and to touch his knees when he is told to "touch his shoulder". If he is successful at this level, he is asked to touch his knees when he is told to "touch his head", to touch his shoulders when he is told to "touch his feet", to touch his feet when he is told to "touch his shoulder" and to touch his head when he is told to "touch his knees". If he can do the given command without any mistakes, he is given 2 points, if he is oriented towards the wrong and does it correctly, he is given 1 point and if he gives the wrong answer, he is given 0 points. A total score of 0-60 is given with 10 applications at each level. As the score increases, the self-regulation score will increase.
Occupational Performance
Time frame: 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.
The Canadian Occupational Performance Measure (COPM) is a general questionnaire based on a semistructured interview. The semistructured design allows individuals to identify important occupations that they have difficulty performing. COPM is derived from the Canadian Activity Performance Model, which defines occupational performance as the ability to organize, select, and perform meaningful occupations that are culturally defined and age-appropriate for taking care of oneself, enjoying life, building the economic fabric of society, and contributing to the social world. The fifth version of the COPM was published in 2014 and its Turkish adaptation has been made.
Problematic Media Use
Time frame: 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.
It was developed to determine problematic media use in children between the ages of 4 and 11. The items of the scale were created by taking into account the Internet Gaming Disorder criteria expressed in DSM V. The scale consists of a 27-item form. The scale is Likert-type and each item is scored between 1 (never) and 5 (always). The total score obtained from the Problematic Media Use Scale is calculated by averaging the scores obtained from all items. High scores obtained from the scale indicate problematic use. While the scale, which is filled out by parents considering the child's behavior, does not provide information on the problematic use of a specific media tool, it tries to determine the problematic use of visual media tools (such as phones, tablets, computers, televisions) in general, in other words, screen addiction.
Occupational Profile
Time frame: 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.
This assessment tool comprises 25 items organized into six sections. The initial five sections (volition, habituation, communication \& interaction skills, process skills, motor skills) evaluate the child's personal attributes and their influence on participation and performance in various activities. The final section investigates the impact of the environment on the child's capacity to engage in and perform these activities. A four-point ordinal scale is employed for scoring individual items, using the following codes: F = Facilitates A = Allows I = Inhibits R = Restricts participation Numerical values are assigned to each code, ranging from 4 to 0. Specifically, 'F' is assigned a value of 4, 'A' is 3, 'I' is 2, and 'R' is 1. The item scores are summed, yielding a maximum total score of 100 for the entire assessment. The minimum score is 25.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Background: PubMed 28231484Argumosa-Villar L, Boada-Grau J, Vigil-Colet A. Exploratory investigation of theoretical predictors of nomophobia using the Mobile Phone Involvement Questionnaire (MPIQ). J Adolesc. 2017 Apr;56:127-135. doi: 10.1016/j.adolescence.2017.02.003. Epub 2017 Feb 21.
- Background: PubMed 15586853Carswell A, McColl MA, Baptiste S, Law M, Polatajko H, Pollock N. The Canadian Occupational Performance Measure: a research and clinical literature review. Can J Occup Ther. 2004 Oct;71(4):210-22. doi: 10.1177/000841740407100406.
- Background: PubMed 32955952Wennberg B, Janeslatt G, Gustafsson PA, Kjellberg A. Occupational performance goals and outcomes of time-related interventions for children with ADHD. Scand J Occup Ther. 2021 Feb;28(2):158-170. doi: 10.1080/11038128.2020.1820570. Epub 2020 Sep 21.
- BackgroundMathews, S. B., Mozolic-Staunton, B., Jefford, E., & Salehi, N. (2020). Canadian Occupational Performance Measure and early intervention: A scoping review. Journal of Occupational Therapy, Schools, & Early Intervention, 13(4), 353-373.
- Background: PubMed 32003027Dadson P, Brown T, Stagnitti K. Relationship between screen-time and hand function, play and sensory processing in children without disabilities aged 4-7 years: A exploratory study. Aust Occup Ther J. 2020 Aug;67(4):297-308. doi: 10.1111/1440-1630.12650. Epub 2020 Jan 30.
- Background: PubMed 21630084Koziol LF, Budding DE, Chidekel D. Sensory integration, sensory processing, and sensory modulation disorders: putative functional neuroanatomic underpinnings. Cerebellum. 2011 Dec;10(4):770-92. doi: 10.1007/s12311-011-0288-8.
- Background: PubMed 27447451Wang L, Wu L, Lin X, Zhang Y, Zhou H, Du X, Dong G. Altered brain functional networks in people with Internet gaming disorder: Evidence from resting-state fMRI. Psychiatry Res Neuroimaging. 2016 Aug 30;254:156-63. doi: 10.1016/j.pscychresns.2016.07.001. Epub 2016 Jul 6.
- Background: PubMed 27590829Brand M, Young KS, Laier C, Wolfling K, Potenza MN. Integrating psychological and neurobiological considerations regarding the development and maintenance of specific Internet-use disorders: An Interaction of Person-Affect-Cognition-Execution (I-PACE) model. Neurosci Biobehav Rev. 2016 Dec;71:252-266. doi: 10.1016/j.neubiorev.2016.08.033. Epub 2016 Aug 30.
- Background: PubMed 26728566Takeuchi H, Taki Y, Hashizume H, Asano K, Asano M, Sassa Y, Yokota S, Kotozaki Y, Nouchi R, Kawashima R. Impact of videogame play on the brain's microstructural properties: cross-sectional and longitudinal analyses. Mol Psychiatry. 2016 Dec;21(12):1781-1789. doi: 10.1038/mp.2015.193. Epub 2016 Jan 5.
- Background: PubMed 25241193Atkin AJ, Sharp SJ, Corder K, van Sluijs EM; International Children's Accelerometry Database (ICAD) Collaborators. Prevalence and correlates of screen time in youth: an international perspective. Am J Prev Med. 2014 Dec;47(6):803-7. doi: 10.1016/j.amepre.2014.07.043. Epub 2014 Sep 16.
- Background: PubMed 32076738Rasmussen M, Damsgaard MT, Morgen CS, Kierkegaard L, Toftager M, Rosenwein SV, Krolner RF, Due P, Holstein BE. Trends in social inequality in overweight and obesity among adolescents in Denmark 1998-2018. Int J Public Health. 2020 Jun;65(5):607-616. doi: 10.1007/s00038-020-01342-1. Epub 2020 Feb 20.
- Background: PubMed 31012934Yang L, Cao C, Kantor ED, Nguyen LH, Zheng X, Park Y, Giovannucci EL, Matthews CE, Colditz GA, Cao Y. Trends in Sedentary Behavior Among the US Population, 2001-2016. JAMA. 2019 Apr 23;321(16):1587-1597. doi: 10.1001/jama.2019.3636.
- 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 Occupation-based Self-Regulation Intervention Program and Family Awareness Training in people with Screen Time Exposure, run by Saglik Bilimleri Universitesi 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 6 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Screen Time (time frame: 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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07004036, which also lists 25 linked publications.
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 6 Jun 2025.