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ExposureEPURENCT06835478

Evaluate a Local Program to Reduce the Risky Use of Screens by Children Under 3, Based on the Experience of Parents Who Successfully Stopped This Exposure.

A study testing EPURE + : EPURE program and EPURE - : Standard practices in people with Exposure and Child Development, run by Centre Hospitalier de Saint-Denis at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Early exposure to screens puts children at risk of later neurodevelopmental delay. This exposure is particularly prevalent among the underprivileged populations in our study area, and we don't yet know the motivations, factors and constraints that need to be put in place to remedy the situation. Read more about this study

Who is it for?
Any age
Conditions the study is for
Exposure, Child Development
What is being tested?
EPURE + : EPURE program and EPURE - : Standard practices
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
1 siteFrance
Study dates
1 Apr 2025to 1 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Live in Saint-Denis (France)
  • Parent(s) of child(ren) for whom the family has declared that they have succeeded in stopping or totally modifying their behaviour with screens before the child's 3rd birthday (standard form for all health record follow-up examinations).
  • Declaration confirmed by the negativation of the SCREEN result calculated a posteriori for two periods (before and after stopping), at least 3 months apart.
  • No objection to the use of data for research purposes.

Who cannot join

  • Non-French-speaking public
  • Severe neurological or sensory disorder in the child
  • Child in alternating custody with difficulty accessing screen exposure in the other custody arrangement.
  • Refusal to use data

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site
  • Centre Hopitalier de Saint-Denis

    Saint-Denis, Seine Saint Denis, 93200

    Stéphanie COSSEC, 0142356140, stephanie.cossec@ghtpdfr.fr

    Leila JANNEL, Doctor

Other trials in France

About this study

Official title: Evaluate a Local Program to Reduce the Risky Use of Screens by Children Under 3, Based on the Experience of Parents Who Successfully Stopped This Exposure (EPURE)

Early exposure to screens puts children at risk of later neurodevelopmental delay. This exposure is particularly prevalent among the underprivileged populations in our study area, and we don't yet know the motivations, factors and constraints that need to be put in place to remedy the situation.

Our approach is a bottom-up study, based on the experience of parents who stopped their child's exposure to screens before age 3, to develop a program to reduce early exposure to screens. This will then be tested on a larger scale via a randomized trial

Read the detailed description

The research will be performed in 2 phases:

Phase 1: No intervention, an qualitative and observational phase.

We will identify participants through parents' reports during standard pediatric follow-up consultations. Those who report the cessation of screen exposure will be interviewed using the SCREEN survey, both before and at least 3 months after cessation. Our study's objectives will be presented along with an oral agreement. These "expert parents" will be contacted by phone to gather necessary data for sampling before any qualitative interview. Our aim is to have a carefully selected, homogeneous sample, rather than a representative one. Eligible parents may differ based on certain criteria, leading to potential bias : child's age, presence of older siblings, parents' socio-professional category, childcare arrangements for children <3 years of age, screen-free period (lockdown or not). Inclusion will occur after this stage.

The objectives of this interview are as follows:

  1. Identify the factors that led to screen exposure.
  2. Triggering factors in parents' motivation to change.
  3. Practical aspects of change: obstacles, driving forces, family needs

The results of this survey will form the basis for the EPURE program. Working sessions with a multi-professional working group should define :

  1. The most effective methods for transmitting information, whether visual or oral.
  2. The medium used to convey the information (such as drawing, text, diagram, video, face-to-face...)
  3. The chosen mode of communication, which could be vertical (conference, consultation, expert opinion) or horizontal (feedback, workshops with expert parents, etc.).
  4. Proposed alternatives, such as donating or lending games, referring to socialization centers, providing psychological support, etc.

Final implementation will depend on the results of phase 1 and should not be anticipated

PHASE 2 : described as a prospective multicenter interventional study, which falls within the scope of the JARDE law.

The inappropriate use of screens will be identified by completing the SCREEN survey with all families of children under 3 years of age who attend the centers participating in the study. This identification will take place during consultations or "all-inclusive" interviews for children under 3, or during a consultation for a family member who has raised a suspicion of a high-risk situation (for example, a baby being calmed down with a cell phone during a consultation for an older child or a parent for example).

The program will involve the random selection of volunteer families in the cohort. Beforehand, a randomization list will be prepared and provided to the centers in sealed envelopes, each containing an encrypted code corresponding to the inclusion arm. This method was chosen for its minimal disruption to daily consultation practice. Neither the investigator nor the family will have access to the meaning of the code, ensuring unbiased selection.

Being tested
EPURE + : EPURE program, EPURE - : Standard practices
Keywords
screens, screens exposure, child Development

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EPURE + : EPURE programBehavioural

    EPURE program will be tested.

  • EPURE - : Standard practicesBehavioural

    This group will receive standard practices to prevent the use of screens in child under 3

Study groups in NCT06835478
Study groupRoleWhat they receive
EPURE +Active comparatorIn this phase, a tool will be tested aimed to reduce screen time. A screen will be conducted at 2 and 6 months to measure the program's effectiveness.
Receives: Behavioral: EPURE + : EPURE program
EPURE -Active comparatorIn this arm, no tool will be used. This arm will require only advices. Depending on the result of the screen at 2 months, adjustement will be made. * Failure : They will be added to the EPURE +'s arm. * Success : screen at 6 months
Receives: Behavioral: EPURE - : Standard practices

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Demographic informationns (child)

    First and last name, age

    Measured: [Day 1]

  2. Results of SCREEN survey

    SCREEN Survey's results.

    Measured: [Day 1]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2025
  2. Study start1 Apr 2025 (estimated)
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
290 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06835478
Sponsor's protocol ID
CHSD_0032_EPURE
Acronym
EPURE
Status last verified
Feb 2025
First submitted
2 Aug 2024
Last updated
19 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing EPURE + : EPURE program and EPURE - : Standard practices in people with Exposure and Child Development, run by Centre Hospitalier de Saint-Denis at 1 site in France.

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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 19 Feb 2025. 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 France. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demographic informationns (child) (time frame: [Day 1]). The study lists 2 primary outcomes in all. 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 19 Feb 2025; AzTrials last refreshed its copy on 2 Nov 2026.

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