- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Pargol ZANDYAZDI
- 전화번호: +33 3 88 11 54 30
- 이메일: pargol.zandyazdi@chru-strasbourg.fr
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: Control: Standard Practice
Intervention will be compared to standard practice about screen use prevention for adolescents
|
Standard practice
|
|
실험적: 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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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.
기간: 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)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Juliette Dr CHAMBE, Dr, Hôpitaux Universitaires de Strasbourg
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 9461
- 2025-A01775-44 (기타 식별자: N° IDRCB)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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