- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07685951
LACHETONPHONE : Impact of a Dedicated Consultation Using a Structured Interview Guide on Screen Time Among Adolescents Aged 12 to 17 in Primary Care (LACHETONPHONE)
LACHETONPHONE : Impact of a Dedicated Consultation Using a Structured Interview Guide on Screen Time Among Adolescents Aged 12 to 17 in Primary Care: a Multicenter Randomized Study.
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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Pargol ZANDYAZDI
- Numero di telefono: +33 3 88 11 54 30
- Email: pargol.zandyazdi@chru-strasbourg.fr
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Adolescent aged 12 to 17 years at the time of enrolment (participants aged 17 must not have turned 18 on the day of inclusion).
- 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.
(The minor's signature will be sought but is not mandatory. In accordance with Article L1122-2, consent from one parent/legal guardian is sufficient for inclusion and data analysis; however, consent from both parents will be systematically sought.)
- Adolescent affiliated with a health insurance plan (either as the beneficiary or dependent).
Exclusion Criteria:
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: Control: Standard Practice
Intervention will be compared to standard practice about screen use prevention for adolescents
|
Standard practice
|
|
Sperimentale: Experimental: Structured Interview Guide
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.
|
a dedicated consultation with a structured interview guide
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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.
Lasso di tempo: At Baseline and 1-month follow-up (7 consecutive days of measurement at each time point, excluding school holidays)
|
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)
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Juliette Dr CHAMBE, Dr, Hopitaux Universitaires de Strasbourg
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 9461
- 2025-A01775-44 (Altro identificatore: N° IDRCB)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .