- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Anna You
- Telefonní číslo: +82-31-219-4696
- E-mail: uanna@ajou.ac.kr
Studijní záloha kontaktů
- Jméno: Yong Hyuk Choi
- Telefonní číslo: +82-31-219-5182
- E-mail: brainist.cho@gmail.com
Studijní místa
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Suwon, Jižní Korea, 16499
- Ajou Medical University
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Depression (PHQ-9)
Časové okno: 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)
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Maum-EASY Anxiety and Depression Problems
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Big Five Personality Traits (BFI-K-10)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Chang Hyung Hong, Ajou Medical Center
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
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