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临床试验/NCT06835478
NCT06835478尚未招募不适用

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)

Centre Hospitalier de Saint-Denis1 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
290
试验地点
1
主要终点
Demographic informationns (child)

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: EPURE + : EPURE program (Behavioral)

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

干预措施: EPURE - : Standard practices (Behavioral)

结局指标

主要结局

Demographic informationns (child)

时间窗: [Day 1]

First and last name, age

Results of SCREEN survey

时间窗: [Day 1]

SCREEN Survey's results.

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier de Saint-Denis
申办方类型
Other
责任方
Sponsor

研究点 (1)

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