Clinical trial NCT06835478: 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.
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Exposure
Child Development
Keywords: screens
screens exposure
child Development
Lead sponsor: Centre Hospitalier de Saint-Denis
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 290
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Demographic informationns (child)
timeFrame: [Day 1]
measure: Results of SCREEN survey
timeFrame: [Day 1]
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: Centre Hopitalier de Saint-Denis
state: Seine Saint Denis
Study officials:
References: