NCT07667179

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Jun 2026May 2027

First Submitted

Initial submission to the registry

June 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 24, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 19, 2026

Last Update Submit

June 19, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Depression (PHQ-9)

    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)

    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)

Secondary Outcomes (8)

  • Change in Maum-EASY Anxiety and Depression Problems

    Baseline, week 8 (mid-point), week 17 (post-intervention)

  • Change in Maum-EASY Suicide and Crisis Problems

    Baseline, week 8 (mid-point), week 17 (post-intervention)

  • Change in Maum-EASY Externalizing Problems

    Baseline, week 8 (mid-point), week 17 (post-intervention)

  • Change in Maum-EASY Psychological Trauma Problems

    Baseline, week 8 (mid-point), week 17 (post-intervention)

  • Change in Maum-EASY School Life Adjustment

    Baseline, week 8 (mid-point), week 17 (post-intervention)

  • +3 more secondary outcomes

Other Outcomes (4)

  • Change in Big Five Personality Traits (BFI-K-10)

    Baseline, week 8 (mid-point), week 17 (post-intervention)

  • NAVO:J App Log Data (Adherence)

    Throughout the intervention period (week 1 to week 17)

  • Self-Reported Adherence Questionnaire

    Week 17 (post-intervention)

  • +1 more other outcomes

Study Arms (1)

NAVO:J Intervention Group

EXPERIMENTAL

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.

Behavioral: NAVO:J (digital mental health platform)

Interventions

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.

NAVO:J Intervention Group

Eligibility Criteria

Age7 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou Medical University

Suwon, 16499, South Korea

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Chang Hyung Hong

    Ajou Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 19, 2026

First Posted

June 24, 2026

Study Start

June 24, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations