- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06154681
World Digital Detox Program for Enhancing Youth and Family Well-being
Effectiveness of a World Digital Detox Program for Enhancing Youth and Family Well-being: A Multicenter Randomized Controlled Trial
The pervasive presence of digital devices and technology has reshaped contemporary society, providing numerous benefits but also prompting concerns about prolonged screen time, particularly with smartphones and social media. These concerns extend to their impact on interpersonal relationships and mental well-being. The Zep Foundation's World Digital Detox Program to address the challenges posed by excessive screen exposure, social media usage, and digital screen dependency.
This study aimed to assess the efficacy of the digital detox family intervention, endorsed by the World Digital Detox Day program, in curbing the use of digital devices-specifically smartphones and social media-and enhancing the overall well-being of youth and families.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maharashtra
-
Mumbai, Maharashtra, India
- World Digital Detox Day
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
for Caregivers:
- Age 18 or older at baseline assessment;
- Primary caregiver responsible for the care of an adolescent 10-14 who is a resident in the same household
- Able to speak English
- Agreement to participate in the program;
- Consent for self and child to participate in the study.
for Adolescents:
- Age 10-14 at baseline assessment;
- Agreed to participate in the study;
- Caregiver consent to participate in the study.
Exclusion Criteria:
- Serious Medical Conditions requiring frequent hospitalization
- Special Educational Need Children and Adolescents
- Substance abuse
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: World Digital Detox Family Program
The 4-week Self-Help World Digital Detox Family and Society Program is a comprehensive program, with variety of self-guided activities, discussions, and reflection exercises.
The intervention encompasses both individual and collective components.
|
The Self-Help World Digital Detox Family Program spans four weeks and offers a structured approach to tackle the rising issues associated with the overuse of screens, social media, and digital devices within families.
This intervention provides practical tools and strategies to be implemented on a weekly basis.
|
No Intervention: Wait-list Control
Wait-list control group underwent the standard assessment and screening process but not engaged in the intervention during the 4-week period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Stress Scale (PSS)
Time Frame: From baseline to 4-week post intervention
|
The 10-item PSS was used to assess perception of stress.
|
From baseline to 4-week post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Media Multitasking-Revised (MMT-R) scale
Time Frame: From baseline to 4-week post intervention
|
18-item MMT-R scale measured proactive behaviors of compulsive or inappropriate phone use as well as more passive behaviors
|
From baseline to 4-week post intervention
|
Family Communication Scale (FCS)
Time Frame: From baseline to 4-week post intervention
|
10-item FCS was used to measure satisfaction toward the aspects of positive communication among family members
|
From baseline to 4-week post intervention
|
Family Health Behaviours Scale (FHBS)
Time Frame: From baseline to 4-week post intervention
|
27-items FHBS scale includes the subscales to assess parental behavior, meal routines, physical activity, and children's behavior.
|
From baseline to 4-week post intervention
|
Mental Health Continuum Short Form (MHC-SF)
Time Frame: From baseline to 4-week post intervention
|
14-items MHC-SF measure the adult's emotional, psychological, and social well-being.
|
From baseline to 4-week post intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Rekha Chaudhari, PhD, World Digital Detox Day, Zep Foundation
- Study Chair: Neha Sharma, PhD, Aarogyam UK
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
Other Study ID Numbers
- Zep-WDDD-I 01
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.
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