- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Anna You
- Telefonnummer: +82-31-219-4696
- E-post: uanna@ajou.ac.kr
Studer Kontakt Backup
- Navn: Yong Hyuk Choi
- Telefonnummer: +82-31-219-5182
- E-post: brainist.cho@gmail.com
Studiesteder
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Suwon, Sør -Korea, 16499
- Ajou Medical University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Depression (PHQ-9)
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Maum-EASY Anxiety and Depression Problems
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Big Five Personality Traits (BFI-K-10)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Chang Hyung Hong, Ajou Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AJOUIRB-IV-2026-290
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