NCT06154681

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

6 months

First QC Date

November 16, 2023

Last Update Submit

November 23, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Perceived Stress Scale (PSS)

    The 10-item PSS was used to assess perception of stress.

    From baseline to 4-week post intervention

Secondary Outcomes (4)

  • Media Multitasking-Revised (MMT-R) scale

    From baseline to 4-week post intervention

  • Family Communication Scale (FCS)

    From baseline to 4-week post intervention

  • Family Health Behaviours Scale (FHBS)

    From baseline to 4-week post intervention

  • Mental Health Continuum Short Form (MHC-SF)

    From baseline to 4-week post intervention

Study Arms (2)

World Digital Detox Family Program

EXPERIMENTAL

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.

Other: World Digital Detox Family Program

Wait-list Control

NO INTERVENTION

Wait-list control group underwent the standard assessment and screening process but not engaged in the intervention during the 4-week period.

Interventions

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.

World Digital Detox Family Program

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Serious Medical Conditions requiring frequent hospitalization
  • Special Educational Need Children and Adolescents
  • Substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

World Digital Detox Day

Mumbai, Maharashtra, India

Location

MeSH Terms

Conditions

Psychological Well-BeingAdolescent Behavior

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Rekha Chaudhari, PhD

    World Digital Detox Day, Zep Foundation

    STUDY DIRECTOR
  • Neha Sharma, PhD

    Aarogyam UK

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2023

First Posted

December 4, 2023

Study Start

January 12, 2023

Primary Completion

July 18, 2023

Study Completion

November 3, 2023

Last Updated

December 4, 2023

Record last verified: 2023-11

Locations