- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07667179
NAVO:J School-Based Group Intervention for Adolescent Mental Health
Effects of a School-Based Group Intervention Using the Digital Mental Health Platform NAVO:J on Adolescent Mental Health
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
NAVO:J is a digital mental health platform designed to promote adolescent mental health.
The intervention will be conducted as a single-group pre-post design with students (N = 250 subjects) who apply for the Level 2-2 (group intervention) program.
The intervention period will be 17 weeks (17 sessions, once a week for about 40 minutes), with a mid-point evaluation at week 8 and a post-intervention evaluation at week 17.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Anna You
- Номер телефона: +82-31-219-4696
- Электронная почта: uanna@ajou.ac.kr
Учебное резервное копирование контактов
- Имя: Yong Hyuk Choi
- Номер телефона: +82-31-219-5182
- Электронная почта: brainist.cho@gmail.com
Места учебы
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Suwon, Южная Корея, 16499
- Ajou Medical University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Students who apply for the group intervention program
- Possession of an internet-enabled smartphone
- Consent to study participation by both the participant and their legal guardian
Exclusion Criteria:
- Inability to install or run "NAVO:J" on the participant's smartphone
- Current participation in another interventional study
- A medical condition severe enough to preclude the intervention or outcome assessment
- Judged by the researcher to be unlikely to participate cooperatively through the end of the study
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: NAVO:J Intervention Group
Participants in this single-arm group use the digital mental health platform NAVO:J for 17 weeks (17 sessions, once a week for approximately 40 minutes).
Each session includes app-based activities such as recommended mental health videos, tailored self-care solutions, self-assessments, mind coaching, and diary entries.
Mental health outcomes are assessed at baseline, mid-point (week 8), and post-intervention (week 17) using a single-group pre-post design.
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Participants use NAVO:J, a digital mental health platform developed for adolescents, delivered as a structured group intervention over 17 weeks (17 sessions, once weekly, approximately 40 minutes each).
The platform provides algorithm-based recommended videos, 12 tailored "mind solutions" based on emotional-behavioral characteristics, self-assessments (personality, depression, anxiety, stress, self-esteem, smartphone use), expert-supported community features, mind coaching, growth tracking across 10 adolescent mental health indicators, and a mood diary.
Sessions are facilitated weekly by trained researchers following a standardized manual.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Depression (PHQ-9)
Временное ограничение: Baseline, week 8 (mid-point), week 17 (post-intervention)
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Depression is measured using the Korean version of the Patient Health Questionnaire-9 (PHQ-9), based on the DSM-IV criteria for major depressive disorder, assessing symptoms experienced over the past two weeks.
The scale consists of 9 items rated on a 4-point Likert scale (score range: 0-27).
Higher scores indicate more severe depressive symptoms.
Change is assessed by comparing scores at baseline, mid-point, and post-intervention.
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Baseline, week 8 (mid-point), week 17 (post-intervention)
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Change in Resilience (CD-RISC-10)
Временное ограничение: Baseline, week 8 (mid-point), week 17 (post-intervention)
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Resilience is measured using the 10-item Connor-Davidson Resilience Scale (CD-RISC-10), a self-report measure of an individual's ability to recover and adapt under adversity or stress.
Each item is rated on a 5-point Likert scale (score range: 0-40).
Higher scores indicate greater resilience.
Change is assessed by comparing scores at baseline, mid-point, and post-intervention.
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Baseline, week 8 (mid-point), week 17 (post-intervention)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Maum-EASY Anxiety and Depression Problems
Временное ограничение: Baseline, week 8 (mid-point), week 17 (post-intervention)
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The Maum-EASY Test is a self-report screening tool developed to detect students' mental health problems early and prevent worsening.
The anxiety and depression subscale measures the level of anxiety- and depression-related problems, with each item rated on a 4-point Likert scale (0-3).
Higher scores indicate a greater likelihood of such problems (score range: 0-24).
Change is assessed by comparing scores at baseline, mid-point, and post-intervention.
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Baseline, week 8 (mid-point), week 17 (post-intervention)
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Change in Maum-EASY Suicide and Crisis Problems
Временное ограничение: Baseline, week 8 (mid-point), week 17 (post-intervention)
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The suicide and crisis subscale of the Maum-EASY Test measures the level of serious risk symptoms such as suicidality and severe psychological problems, with each item rated on a 4-point Likert scale (0-3).
Higher scores indicate a greater need for priority attention and intervention (score range: 0-18).
Change is assessed by comparing scores at baseline, mid-point, and post-intervention.
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Baseline, week 8 (mid-point), week 17 (post-intervention)
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Change in Maum-EASY Externalizing Problems
Временное ограничение: Baseline, week 8 (mid-point), week 17 (post-intervention)
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The externalizing subscale of the Maum-EASY Test measures the level of outwardly expressed behavioral problems, with each item rated on a 4-point Likert scale (0-3).
Higher scores indicate a greater likelihood of problems such as oppositional behavior, delinquency, and habitual lying (score range: 0-24).
Change is assessed by comparing scores at baseline, mid-point, and post-intervention.
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Baseline, week 8 (mid-point), week 17 (post-intervention)
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Change in Maum-EASY Psychological Trauma Problems
Временное ограничение: Baseline, week 8 (mid-point), week 17 (post-intervention)
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The psychological trauma subscale of the Maum-EASY Test measures the presence of traumatic experiences and related problems, with each item rated on a 4-point Likert scale (0-3).
Higher scores indicate a greater likelihood of problems such as intrusive memories, avoidance of others, and distrust of others (score range: 0-21).
Change is assessed by comparing scores at baseline, mid-point, and post-intervention.
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Baseline, week 8 (mid-point), week 17 (post-intervention)
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Change in Maum-EASY School Life Adjustment
Временное ограничение: Baseline, week 8 (mid-point), week 17 (post-intervention)
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The school life adjustment subscale of the Maum-EASY Test measures difficulties related to school adjustment and reduced coping skills, with each item rated on a 4-point Likert scale (0-3).
Higher scores indicate a greater likelihood of problems such as lack of confidence, maladaptive coping, and difficulty making friends (score range: 0-21).
Change is assessed by comparing scores at baseline, mid-point, and post-intervention.
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Baseline, week 8 (mid-point), week 17 (post-intervention)
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Change in Subjective Mental Health (VAS)
Временное ограничение: Baseline, week 8 (mid-point), week 17 (post-intervention)
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Subjective mental health is measured using a self-report Visual Analog Scale (VAS) developed by the research team to multidimensionally assess adolescents' perceived mental health.
It consists of 9 items, each rated on an 11-point scale from 0 (not at all) to 10 (very much).
It is used as a supplementary measure of overall perceived mental health.
Change is assessed by comparing scores at baseline, mid-point, and post-intervention.
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Baseline, week 8 (mid-point), week 17 (post-intervention)
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Change in Empathy Quotient (K-EQ)
Временное ограничение: Baseline, week 8 (mid-point), week 17 (post-intervention)
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Empathy is measured using the Korean version of the Empathy Quotient (K-EQ), which assesses multidimensional empathic ability across cognitive empathy, emotional empathy, and social skills.
It consists of 17 items rated on a 4-point Likert scale (score range: 17-68).
Higher scores indicate greater empathic ability.
Change is assessed by comparing scores at baseline, mid-point, and post-intervention.
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Baseline, week 8 (mid-point), week 17 (post-intervention)
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Change in Grit (GRIT-S)
Временное ограничение: Baseline, week 8 (mid-point), week 17 (post-intervention)
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Grit is measured using the Short Grit Scale (GRIT-S), comprising two subfactors: consistency of effort and consistency of interest.
It consists of 8 items rated on a 5-point Likert scale (score range: 6-30).
Higher scores indicate greater grit.
Change is assessed by comparing scores at baseline, mid-point, and post-intervention.
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Baseline, week 8 (mid-point), week 17 (post-intervention)
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in Big Five Personality Traits (BFI-K-10)
Временное ограничение: Baseline, week 8 (mid-point), week 17 (post-intervention)
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Personality is measured using a 15-item short form of the Big Five Inventory, comprising five subfactors: neuroticism, extraversion, openness, agreeableness, and conscientiousness.
Each item is rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree) (score range: 15-75).
Change is assessed by comparing scores at baseline, mid-point, and post-intervention.
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Baseline, week 8 (mid-point), week 17 (post-intervention)
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NAVO:J App Log Data (Adherence)
Временное ограничение: Throughout the intervention period (week 1 to week 17)
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Objective adherence is assessed using NAVO:J platform log data, including app access time and the scope of activities completed during the study period.
This measure is used to verify participant compliance with the intervention.
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Throughout the intervention period (week 1 to week 17)
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Self-Reported Adherence Questionnaire
Временное ограничение: Week 17 (post-intervention)
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Subjective adherence is assessed using a self-report questionnaire on the number and duration of app sessions during the study period, administered at the post-intervention assessment.
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Week 17 (post-intervention)
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Smartphone App Satisfaction Questionnaire
Временное ограничение: Week 17 (post-intervention)
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App satisfaction is assessed using a self-report questionnaire evaluating ease of use, information reliability and quality, perceived improvement in mental health, and overall satisfaction, administered at the post-intervention assessment.
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Week 17 (post-intervention)
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Соавторы и исследователи
Следователи
- Главный следователь: Chang Hyung Hong, Ajou Medical Center
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- AJOUIRB-IV-2026-290
Планирование данных отдельных участников (IPD)
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