- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Anna You
- Telefoonnummer: +82-31-219-4696
- E-mail: uanna@ajou.ac.kr
Studie Contact Back-up
- Naam: Yong Hyuk Choi
- Telefoonnummer: +82-31-219-5182
- E-mail: brainist.cho@gmail.com
Studie Locaties
-
-
-
Suwon, Zuid -Korea, 16499
- Ajou Medical University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Depression (PHQ-9)
Tijdsspanne: Baseline, week 8 (mid-point), week 17 (post-intervention)
|
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.
|
Baseline, week 8 (mid-point), week 17 (post-intervention)
|
|
Change in Resilience (CD-RISC-10)
Tijdsspanne: Baseline, week 8 (mid-point), week 17 (post-intervention)
|
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.
|
Baseline, week 8 (mid-point), week 17 (post-intervention)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Maum-EASY Anxiety and Depression Problems
Tijdsspanne: Baseline, week 8 (mid-point), week 17 (post-intervention)
|
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.
|
Baseline, week 8 (mid-point), week 17 (post-intervention)
|
|
Change in Maum-EASY Suicide and Crisis Problems
Tijdsspanne: Baseline, week 8 (mid-point), week 17 (post-intervention)
|
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.
|
Baseline, week 8 (mid-point), week 17 (post-intervention)
|
|
Change in Maum-EASY Externalizing Problems
Tijdsspanne: Baseline, week 8 (mid-point), week 17 (post-intervention)
|
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.
|
Baseline, week 8 (mid-point), week 17 (post-intervention)
|
|
Change in Maum-EASY Psychological Trauma Problems
Tijdsspanne: Baseline, week 8 (mid-point), week 17 (post-intervention)
|
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.
|
Baseline, week 8 (mid-point), week 17 (post-intervention)
|
|
Change in Maum-EASY School Life Adjustment
Tijdsspanne: Baseline, week 8 (mid-point), week 17 (post-intervention)
|
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.
|
Baseline, week 8 (mid-point), week 17 (post-intervention)
|
|
Change in Subjective Mental Health (VAS)
Tijdsspanne: Baseline, week 8 (mid-point), week 17 (post-intervention)
|
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.
|
Baseline, week 8 (mid-point), week 17 (post-intervention)
|
|
Change in Empathy Quotient (K-EQ)
Tijdsspanne: Baseline, week 8 (mid-point), week 17 (post-intervention)
|
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.
|
Baseline, week 8 (mid-point), week 17 (post-intervention)
|
|
Change in Grit (GRIT-S)
Tijdsspanne: Baseline, week 8 (mid-point), week 17 (post-intervention)
|
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.
|
Baseline, week 8 (mid-point), week 17 (post-intervention)
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in Big Five Personality Traits (BFI-K-10)
Tijdsspanne: Baseline, week 8 (mid-point), week 17 (post-intervention)
|
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.
|
Baseline, week 8 (mid-point), week 17 (post-intervention)
|
|
NAVO:J App Log Data (Adherence)
Tijdsspanne: Throughout the intervention period (week 1 to week 17)
|
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.
|
Throughout the intervention period (week 1 to week 17)
|
|
Self-Reported Adherence Questionnaire
Tijdsspanne: Week 17 (post-intervention)
|
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.
|
Week 17 (post-intervention)
|
|
Smartphone App Satisfaction Questionnaire
Tijdsspanne: Week 17 (post-intervention)
|
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.
|
Week 17 (post-intervention)
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Chang Hyung Hong, Ajou Medical Center
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- AJOUIRB-IV-2026-290
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .