- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Pargol ZANDYAZDI
- Número de teléfono: +33 3 88 11 54 30
- Correo electrónico: pargol.zandyazdi@chru-strasbourg.fr
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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.
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Juliette Dr CHAMBE, Dr, Hopitaux Universitaires de Strasbourg
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 9461
- 2025-A01775-44 (Otro identificador: N° IDRCB)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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