NCT07704996

Brief Summary

Study Aim and Methods (≈250 words) It aims to evaluate the effectiveness, user perceptions, and applicability of the e-CAMP intervention in improving mental well-being and reducing depressive symptoms among adolescents aged 11-15 years. The primary research question is whether e-CAMP can significantly reduce depressive symptoms, measured by the Patient Health Questionnaire-9 (PHQ-9). Secondary objectives are to examine whether e-CAMP : improves mental health literacy using the Chinese-version Universal Mental Health Literacy Scale for Adolescents (UMHL), promotes healthier smart device use as measured by the Smartphone Addiction Scale (SAS), increases physical activity assessed through the Global Adolescent and Child Physical Activity Questionnaire (GAC-PAQ) , and to evaluate participants' perceptions of the intervention's applicability, acceptability through survey. A prospective two-arm cluster randomized controlled trial (RCT) following CONSORT 2010 guidelines will be conducted in eight eligible Hong Kong schools, which will be randomly assigned to either the intervention or usual-care group. A process evaluation will also be undertaken. 320 students will be recruited with inclusion criteria : Chinese students aged 11-15 years (Primary 5 to Secondary 2) with parental consent. Students with physical, cognitive, or mental conditions that may affect participation will be excluded. Students in the intervention group will receive usual school care and access to the e-CAMP mobile app, which they will be encouraged to use at least three times weekly for eight weeks (10-15 minutes per session). Students in the control group will receive usual school care, including a 45-minute nurse-led health talk and PowerPoint handouts.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Aug 2026

Typical duration 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 Progress7%
Aug 2026Dec 2028

First Submitted

Initial submission to the registry

July 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

August 3, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

12 months

First QC Date

July 10, 2026

Last Update Submit

July 15, 2026

Conditions

Keywords

mental healthdepressionadolescentsprogrammeAImobile application

Outcome Measures

Primary Outcomes (1)

  • change of depression scoreby Patient Health questionnaire (PHQ9 )

    Depressive symptoms will be assessed using the PHQ9 \[13\], a widely used depression screening tool comprising nine items (scores: 0-3) and a total score range of 0-27. Scores of 0-4, 5-9, 10-14, 15-19, and ≥20 indicate minimal, mild, moderate, moderate-severe, and severe depression, respectively. The PHQ9 has good psychometric properties for use in adolescent populations

    4 months

Secondary Outcomes (3)

  • Change in mental health literarcy by The Chinese-version UMHL for adolescents

    4 months

  • Change in amart phone addiction (SAS)

    4 months

  • Change in exercise behaviour by Global Physical Activity Questionnaire (GPAQ)

    4 months

Study Arms (2)

experimental : app group

EXPERIMENTAL

app group :The e-CAMP mobile app is an AI-enhanced behavioural health promotion intervention in which AI functionalities support engagement and timely prompting. The app's front page directs users to two sections: an educational module and an individual member area. The educational module includes animations and five learning units covering: 1. Facts and risk factors for depression in adolescents. 2. Depressive signs, symptoms, and care. 3. Strategies/tips for promoting well being (healthy diet, exercise, balanced use of smart devices and social media). 4. Stress management and substance abuse avoidance. 5. Help seeking resources. The individual member area displays personalised data on daily physical activities (goal, type and duration). Students can access AI enhanced self learning features, the Three Kingdoms game, and self reflection functions.

Device: mobile app group

control group : face to face health talk

ACTIVE COMPARATOR

Participants in control schools will be selected based on the above-stated inclusion and exclusion criteria. Eligible students will receive usual school care, a 45-minute health talk delivered by a nurse, and a mental health assessment survey . The health talk, titled 'Enhance mental well-being and prevent depression', has been generated from e-CAMP app content. A PowerPoint handout will be provided to all participants after the health talk. Upon study completion, all participants will receive access to the e-CAMP mobile app and an installation guide.

Behavioral: Control Group :health talk and usual care by school

Interventions

control group-usual care . Eligible students will receive usual school care, a 45-minute health talk delivered by a nurse . The health talk, titled 'Enhance mental well-being and prevent depression', has been generated from e-CAMP app content. A PowerPoint handout will be provided to all participants after the health talk.

control group : face to face health talk

In addition to receiving the usual school care, participants in intervention schools will be provided a QR code and installation guide and instructed to install the e-CAMP mobile app. WhatsApp groups will be established among students (approx. 15 students/class), volunteer schoolteachers, and research assistants (RAs) to facilitate communication and address inquiries. Participants will be encouraged to use the e-CAMP app at least thrice weekly during the first 8 weeks of the intervention. Each usage session is expected to last approximately 10-15 minutes. Participants can share and discuss the e-CAMP app with their parents.

experimental : app group

Eligibility Criteria

Age11 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • Students with known physical (musculoskeletal) or cognitive/mental problems that would compromise physical exercise or our intervention or outcomes will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tung Wah College

Hong Kong, Hong Kong, 00, China

Location

MeSH Terms

Conditions

Psychological Well-BeingDepression

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorBehavioral Symptoms

Study Officials

  • Eliza ML Wong, PhD

    Tung Wah College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliza ML Wong, PhD

CONTACT

Alan HL Tam, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
the researcher who will do the data analysis
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Experimental group : In addition to receiving the usual school care, participants in intervention schools will be provided with a QR code and installation guide and instructed to install the e-CAMP mobile app. Participants will be encouraged to use the e-CAMP app at least thrice weekly during the first 8 weeks of the intervention. Each usage session is expected to last approximately 10-15 minutes. Participants can share and discuss the e-CAMP app with their parents. Control group : Participants in control schools will be selected based on the above-stated inclusion and exclusion criteria. Eligible students will receive usual school care, a 45-minute health talk delivered by a nurse, and a mental health assessment survey. The health talk, titled 'Enhance mental well-being and prevent depression', has been generated from e-CAMP app content. A PowerPoint handout will be provided to all participants after the health talk.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 10, 2026

First Posted

July 15, 2026

Study Start

August 3, 2026

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

the plan can be in due course after completion of the study

Locations