The Effects Of Occupation-Based Self-Regulation Program On Sensory Processing, Executive Functions and Occupational Performance In Preschool Children With Screen Addiction

NCT07004036 | Active Not Recruiting DMC

• 1 other identifier: 2023/84-2023080
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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?

Conditions

Screen Time Exposure

Keywords

Screen Time Exposure; Executive Function; Self-control; Sensory Processing

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

Study Arms (2)

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.

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.

Behavioral: Family Awareness Training

Interventions

Occupation-based Self-Regulation Intervention Program BEHAVIORAL

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.

Intervention Group

Family Awareness Training BEHAVIORAL

Family awareness training on the harms of screen addiction and prolonged exposure to the screen, as a one-time event.

Control Group

Eligibility Criteria

• Age: 48 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Health Sciences University

Ankara, 06010, Turkey (Türkiye)

Location

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MeSH Terms

Conditions

Self-Control

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: June 4, 2025
• Study Start: March 21, 2025
• Primary Completion: April 1, 2025
• Study Completion: June 30, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)