Psychological Well-BeingNCT06154681
World Digital Detox Program for Enhancing Youth and Family Well-being
A study testing World Digital Detox Family Program in people with Psychological Well-Being and Adolescent Behavior, run by Innowage Limited at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Well-Being, Adolescent Behavior, Family
- What is being tested?
- World Digital Detox Family Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteIndia
- Study dates
- 12 Jan 2023to 3 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Show all 10Show fewer
- for Adolescents:
- Age 10-14 at baseline assessment;
- Agreed to participate in the study;
- Caregiver consent to participate in the study.
Who cannot join
- Serious Medical Conditions requiring frequent hospitalization
- Special Educational Need Children and Adolescents
- Substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Psychological Well-Being, Adolescent Behavior, Family
- Being tested
- World Digital Detox Family Program
- Medical subject headings
- Psychological Well-Being, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
World Digital Detox Family ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Scale (PSS)
The 10-item PSS was used to assess perception of stress.
Measured: From baseline to 4-week post intervention
Secondary outcomes (4)
Media Multitasking-Revised (MMT-R) scale
18-item MMT-R scale measured proactive behaviors of compulsive or inappropriate phone use as well as more passive behaviors
Measured: From baseline to 4-week post intervention
Family Communication Scale (FCS)
10-item FCS was used to measure satisfaction toward the aspects of positive communication among family members
Measured: From baseline to 4-week post intervention
Family Health Behaviours Scale (FHBS)
27-items FHBS scale includes the subscales to assess parental behavior, meal routines, physical activity, and children's behavior.
Measured: From baseline to 4-week post intervention
Mental Health Continuum Short Form (MHC-SF)
14-items MHC-SF measure the adult's emotional, psychological, and social well-being.
Measured: From baseline to 4-week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start12 Jan 2023
- Primary completion18 Jul 2023
- Study completion3 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological Well-BeingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innowage Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zep Foundation, Aarogyam UK
- Responsible party
- Sponsor
- Investigators
- Rekha Chaudhari, PhD, Study director, World Digital Detox Day, Zep FoundationNeha Sharma, PhD, Study chair, Aarogyam UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154681
- Sponsor's protocol ID
- Zep-WDDD-I 01
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a World Digital Detox Program for Enhancing Youth and Family Well-being: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06154681
- Acronym / sponsor ID
- Zep-WDDD-I 01
- Conditions
- Psychological Well-Being, Adolescent Behavior, Family
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Innowage LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Zep Foundation, Aarogyam UK
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 4 Dec 2023 (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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| World Digital Detox Family Program | Experimental | Other: World Digital Detox Family ProgramThe 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. |
| 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. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (3 listed)
- Serious Medical Conditions requiring frequent hospitalization
- Special Educational Need Children and Adolescents
- Substance abuse
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 |
|---|---|---|
| World Digital Detox Family ProgramThe 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. | Other | World Digital Detox Family Program |
Primary outcome
Perceived Stress Scale (PSS)
Time frame: From baseline to 4-week post intervention
The 10-item PSS was used to assess perception of stress.
4 secondary outcomes
Media Multitasking-Revised (MMT-R) scale
Time frame: From baseline to 4-week post intervention
Family Communication Scale (FCS)
Time frame: From baseline to 4-week post intervention
Family Health Behaviours Scale (FHBS)
Time frame: From baseline to 4-week post intervention
Mental Health Continuum Short Form (MHC-SF)
Time frame: From baseline to 4-week post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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.
Rekha Chaudhari, PhD study director
World Digital Detox Day, Zep Foundation
Neha Sharma, PhD study chair
Aarogyam UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing World Digital Detox Family Program in people with Psychological Well-Being and Adolescent Behavior, run by Innowage Limited at 1 site in India.
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 10 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: finished, as of the sponsor's last update on 4 Dec 2023. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perceived Stress Scale (PSS) (time frame: From baseline to 4-week post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2023.