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.

NCT06835478 | Not Yet Recruiting DMC

• 1 other identifier: CHSD_0032_EPURE
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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

Conditions

Exposure; Child Development

Keywords

screens; screens exposure; child Development

Outcome Measures

Primary Outcomes (2)

• Demographic informationns (child)

  First and last name, age

  [Day 1]

• Results of SCREEN survey

  SCREEN Survey's results.

  [Day 1]

Study Arms (2)

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.

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

Behavioral: EPURE - : Standard practices

Interventions

EPURE + : EPURE program BEHAVIORAL

EPURE program will be tested.

EPURE +

EPURE - : Standard practices BEHAVIORAL

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

EPURE -

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Saint-Denis: lead

Study Sites (1)

Centre Hopitalier de Saint-Denis

Saint-Denis, Seine Saint Denis, 93200, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: February 19, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

FR (1)