- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07423689
School-Based Self-Regulation Intervention for Digital Game Addiction and Sleep Deprivation (SRDGA)
A School-Based Self-Regulation Intervention for Reducing Digital Game Addiction and Sleep Deprivation in Adolescents: A Cluster Randomized Controlled Trial
This study evaluates the effectiveness of a school-based self-regulation intervention designed to reduce digital game addiction and sleep deprivation among adolescents aged 10-14 years. Excessive digital gaming has been associated with sleep problems, reduced academic performance, and emotional difficulties in adolescents.
In this cluster randomized controlled trial, two public middle schools were randomly assigned to either an intervention group or a control group. Students in the intervention group participated in a four-week classroom-based self-regulation training program focusing on goal setting, impulse control, time management, and healthy digital use habits.
The control group continued their usual school activities without additional intervention. Outcomes were assessed before the intervention and after completion using validated measures of digital game addiction and sleep deprivation.
The study aims to determine whether strengthening self-regulation skills can reduce problematic gaming behaviors and improve sleep outcomes in adolescents.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This cluster randomized controlled trial was conducted in two public middle schools located in the city center of Türkiye during the 2024-2025 academic year. Schools with similar socio-demographic characteristics were identified, and two schools were selected through a lottery method. One school was assigned to the intervention group and the other to the control group to minimize contamination between participants.
The study targeted students aged 10-14 years identified as being at high risk for digital game addiction based on screening assessments. The intervention consisted of four weekly classroom sessions grounded in Self-Regulation Theory. The program included structured activities focused on self-monitoring of digital gaming behaviors, goal setting, impulse control strategies, time management skills, and sleep hygiene awareness.
The control group did not receive the intervention during the study period and continued their routine school curriculum.
Primary outcomes included levels of digital game addiction and sleep deprivation, measured using validated and age-appropriate standardized scales. Assessments were conducted at baseline (pre-intervention) and after completion of the intervention.
The primary objective of the study is to evaluate the effectiveness of a theory-based school intervention in reducing digital game addiction and sleep deprivation among adolescents.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Zonguldak, Turkey (Türkiye), 67100
- Mithatpaşa İlkokulu
-
Zonguldak, Turkey (Türkiye), 67100
- Rüzgarlımeşe İlkokulu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Enrollment in one of the two selected public middle schools in the city center
- Aged 10-14 years
- Classified as "high-risk" for digital game addiction based on screening assessment
- Ability to understand and complete study questionnaires
- Written informed consent obtained from parents/guardians and assent from students
Exclusion Criteria:
- Diagnosed psychiatric or neurological disorder that may interfere with participation
- Currently receiving psychological or behavioral treatment targeting digital game use
- Inability to attend intervention sessions regularly
- Withdrawal of consent during the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Self-Regulation Intervention Group
Students enrolled in the intervention school who received a 4-week, classroom-based self-regulation training program designed to reduce digital game addiction and sleep deprivation.
The intervention consisted of structured educational sessions grounded in Self-Regulation Theory.
|
A school-based self-regulation intervention grounded in Self-Regulation Theory was delivered over four consecutive weeks.
The program consisted of four structured classroom sessions (one session per week, approximately 40-45 minutes each) targeting self-monitoring, goal setting, impulse control, time management, and healthy digital use behaviors.
Interactive activities, group discussions, and behavioral planning exercises were used.
In addition, a parent/teacher informational seminar was conducted to support consistent behavioral reinforcement.
The control group received no structured intervention during the study period.
|
|
No Intervention: Control Group
Students enrolled in the control school who continued their usual school activities and did not receive the self-regulation intervention during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Digital Game Addiction Scores
Time Frame: Baseline, 4 weeks (post-intervention), and 3 months follow-up
|
Change in Digital Game Addiction Scale total scores from baseline to post-intervention between intervention and control groups.
|
Baseline, 4 weeks (post-intervention), and 3 months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Sleep Deprivation Scores
Time Frame: Baseline, 4 weeks (post-intervention), and 3 months follow-up
|
Change in Sleep Deprivation Scale for Children and Adolescents (SDS-C/A) total scores from baseline to post-intervention between intervention and control groups.
|
Baseline, 4 weeks (post-intervention), and 3 months follow-up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SR-DGA-2024-TR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep Deprivation
-
University of PennsylvaniaCompletedSleep Restriction Then Total Sleep Deprivation | Total Sleep Deprivation Then Sleep RestrictionUnited States
-
Herlev HospitalTRYG Foundation; Danish Medical AssociationCompletedEffect of Sleep DeprivationDenmark
-
Christian BaumannCompletedAcute and Partial Sleep DeprivationSwitzerland
-
Laval UniversityCanadian Institutes of Health Research (CIHR)CompletedControl Condition | Intensive Sleep Retraining | Total Sleep DeprivationCanada
-
Dr. Osman HospitalCairo UniversityUnknownEffect of Insomnia and Sleep Deprivation in 3rdtrimesterEgypt
-
Hallym University Medical CenterCompletedWe Investigated the Effect of Sleep Deprivation on the Tear Film and Ocular Surface.Korea, Republic of
-
Emily GusemanCompleted
-
University of ChicagoCompleted
-
Beth Israel Deaconess Medical CenterNational Institute of Mental Health (NIMH)Active, not recruiting
Clinical Trials on School-Based Self-Regulation Program
-
Comenius UniversityCompletedBurnout, Professional | Occupational Stress | Mental Health | Emotional RegulationSlovakia
-
Saglik Bilimleri UniversitesiActive, not recruiting
-
Global Institute of Human DevelopmentNational Institute of Mental Health (NIMH)Active, not recruitingDepression, Anxiety | Distress, Emotional | Psychosocial Problem | Functioning, PsychosocialPakistan
-
University of Colorado, DenverPatient-Centered Outcomes Research Institute; Emory University; University of...RecruitingAnxiety Disorders | Autism Spectrum Disorder | Emotion RegulationUnited States
-
University of MinhoFundação para a Ciência e a TecnologiaRecruitingHealthy EatingPortugal
-
Federal University of Health Science of Porto AlegreUnknownSelf-regulation in HealthBrazil
-
Centers for Disease Control and PreventionProcter and Gamble; Centers for Disease Control and Prevention, China; Zhejiang... and other collaboratorsCompletedInfectious Disease | Absenteeism | Respiratory IllnessChina, Pakistan, Philippines
-
Hasan Kalyoncu UniversityCompletedSelf Regulation | School Readiness | Attention and FocusTurkey (Türkiye)
-
Children's Hospital Los AngelesLos Angeles County Department of Public HealthCompletedInfluenzaUnited States