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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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:
- Identify the factors that led to screen exposure.
- Triggering factors in parents' motivation to change.
- 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 :
- The most effective methods for transmitting information, whether visual or oral.
- The medium used to convey the information (such as drawing, text, diagram, video, face-to-face...)
- The chosen mode of communication, which could be vertical (conference, consultation, expert opinion) or horizontal (feedback, workshops with expert parents, etc.).
- 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.
- Conditions
- Exposure, Child Development
- 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 group | Role | What they receive |
|---|---|---|
| EPURE + | Active comparator | In 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 comparator | In 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.
Demographic informationns (child)
First and last name, age
Measured: [Day 1]
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.
- First posted19 Feb 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExposureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06835478
- Acronym / sponsor ID
- EPURE / CHSD_0032_EPURE
- Conditions
- Exposure, Child Development
- Keywords
- screens, screens exposure, child Development
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 19 Feb 2025 (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.
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
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:
- Identify the factors that led to screen exposure.
- Triggering factors in parents' motivation to change.
- 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 :
- The most effective methods for transmitting information, whether visual or oral.
- The medium used to convey the information (such as drawing, text, diagram, video, face-to-face...)
- The chosen mode of communication, which could be vertical (conference, consultation, expert opinion) or horizontal (feedback, workshops with expert parents, etc.).
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPURE + | Active comparator | Behavioral: EPURE + : EPURE programIn 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. |
| EPURE - | Active comparator | Behavioral: EPURE - : Standard practicesIn 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| EPURE + : EPURE programEPURE program will be tested. | Behavioural | EPURE + |
| EPURE - : Standard practicesThis group will receive standard practices to prevent the use of screens in child under 3 | Behavioural | EPURE - |
Primary outcome
Demographic informationns (child)
Time frame: [Day 1]
First and last name, age
Results of SCREEN survey
Time frame: [Day 1]
SCREEN Survey's results.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
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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.
1 site in 1 country: see every site and its status.
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.