Trials / Not Yet Recruiting
Not Yet RecruitingNCT06835478
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.
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)
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 290 (estimated)
- Sponsor
- Centre Hospitalier de Saint-Denis · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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. 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: 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | EPURE + : EPURE program | EPURE program will be tested. |
| BEHAVIORAL | EPURE - : Standard practices | This group will receive standard practices to prevent the use of screens in child under 3 |
Timeline
- Start date
- 2025-04-01
- Primary completion
- 2026-11-01
- Completion
- 2027-02-01
- First posted
- 2025-02-19
- Last updated
- 2025-02-19
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT06835478. Inclusion in this directory is not an endorsement.