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

19 de junho de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

250

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Depression (PHQ-9)
Prazo: 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)
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Maum-EASY Anxiety and Depression Problems
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Change in Big Five Personality Traits (BFI-K-10)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Chang Hyung Hong, Ajou Medical Center

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

24 de junho de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2026

Conclusão do estudo (Estimado)

1 de maio de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

19 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

19 de junho de 2026

Primeira postagem (Real)

24 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • AJOUIRB-IV-2026-290

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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