NCT07685951

Brief Summary

Adolescents spend a large amount of time on screens, especially smartphones. Excessive screen use has been linked to health problems such as poor sleep, reduced physical activity, academic difficulties, and mental health issues. Primary care professionals often lack practical tools to help young people address this problem. This study aims to evaluate whether a dedicated medical consultation (DC), using a structured interview guide and a screening questionnaire (e-KID), can help adolescents aged 12 to 17 reduce and improve their screen use. When excessive screen exposure is identified, adolescents are offered a personalized consultation with a healthcare professional. Together, they discuss screen habits, health impacts, and set achievable goals to change usage patterns. The investigator hypothesizes that adolescents who receive this dedicated consultation by healthcare providers trained with a specific grid will better reduce their smartphone screen time and adopt healthier screen use habits compared to those receiving usual care.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
22mo left

Started Oct 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

October 15, 2026

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2028

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

1.8 years

First QC Date

June 29, 2026

Last Update Submit

July 8, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in time spent on the smartphone, measured in hours and minutes (recorded via screenshots), between the baseline visit and one month later, over a period of 7 consecutive days and outside school holidays, in both groups.

    Change in time spent on smartphone use, measured in hours and minutes, assessed via participant screenshots of screen-time statistics. Smartphone use will be recorded over 7 consecutive consecutive days at each time point (baseline and 1 month), excluding school holidays, in both intervention and control groups.

    At Baseline and 1-month follow-up (7 consecutive days of measurement at each time point, excluding school holidays)

Study Arms (2)

Control: Standard Practice

OTHER

Intervention will be compared to standard practice about screen use prevention for adolescents

Behavioral: Standard practice about screen use prevention for adolescents

Experimental: Structured Interview Guide

EXPERIMENTAL

The investigators in the experimental group will be trained in the specific interview framework for the dedicated consultation; they will be required to confirm that they have read and understood how to use it. They will base their dedicated consultation on this interview framework.

Behavioral: Structured Interview Guide

Interventions

a dedicated consultation with a structured interview guide

Experimental: Structured Interview Guide

Standard practice

Control: Standard Practice

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Adolescent owning a smartphone, with usage \>14 hours/week and a score \>10/21 on the early overexposure screening questionnaire (e-KID).
  • Adolescent and parent(s) or legal guardian(s) able to understand the objectives of the research.
  • Adolescent whose parent(s) or legal guardian(s) have signed an electronic informed consent (e-Consent) prior to any study-related procedures.
  • \- Adolescent affiliated with a health insurance plan (either as the beneficiary or dependent).

You may not qualify if:

  • Adolescent with severe psychiatric disorders (DSM-V diagnosis and/or treatment with amphetamines, neuroleptics, or psychotropic drugs).
  • Adolescent currently excluded from participation due to a previous or ongoing study.
  • Adolescent under legal guardianship or conservatorship (tutelle or curatelle).
  • Adolescent female who is pregnant or breastfeeding (self-reported).
  • Adolescent under judicial protection (sauvegarde de justice).
  • Adolescent in an emergency situation, with comprehension difficulties, or cognitive impairment.
  • Adolescent who does not speak or understand French.
  • Adolescent who opposes participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Juliette Dr CHAMBE, Dr

    HOPITAUX UNIVERSITAIRES DE STRASBOURG

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2026

First Posted

July 6, 2026

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

August 15, 2028

Study Completion (Estimated)

August 15, 2028

Last Updated

July 10, 2026

Record last verified: 2026-07