- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Pargol ZANDYAZDI
- Telefonnummer: +33 3 88 11 54 30
- E-Mail: pargol.zandyazdi@chru-strasbourg.fr
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Sonstiges: Control: Standard Practice
Intervention will be compared to standard practice about screen use prevention for adolescents
|
Standard practice
|
|
Experimental: 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
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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.
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Juliette Dr CHAMBE, Dr, Hopitaux Universitaires de Strasbourg
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 9461
- 2025-A01775-44 (Andere Kennung: N° IDRCB)
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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