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NAVO:J School-Based Group Intervention for Adolescent Mental Health

19 de junio de 2026 actualizado por: Chang Hyung Hong, Ajou University School of Medicine

Effects of a School-Based Group Intervention Using the Digital Mental Health Platform NAVO:J on Adolescent Mental Health

The purpose of this study is to determine and verify whether a school-based group intervention using the digital mental health platform NAVO:J can effectively improve the mental health of adolescents-particularly reducing depression, anxiety, and stress while enhancing resilience.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

250

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Anna You
  • Número de teléfono: +82-31-219-4696
  • Correo electrónico: uanna@ajou.ac.kr

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Corea del Sur
      • Suwon, Corea del Sur, 16499
        • Ajou Medical University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Conductual: NAVO:J (digital mental health platform)
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Depression (PHQ-9)
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Maum-EASY Anxiety and Depression Problems
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Big Five Personality Traits (BFI-K-10)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Ajou University School of Medicine

Investigadores

  • Investigador principal: Chang Hyung Hong, Ajou Medical Center

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

24 de junio de 2026

Finalización primaria (Estimado)

31 de diciembre de 2026

Finalización del estudio (Estimado)

1 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

19 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

19 de junio de 2026

Publicado por primera vez (Actual)

24 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

19 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • AJOUIRB-IV-2026-290

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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