Effect of a Programme Including an AI-enhanced Mobile Application on the Mental Well-being of Young Adolescents in Hong Kong - A Cluster RCT Study (AI-eCAMP_RCT)

The goal of this trial is to evaluate the effectiveness, user perception, and applicability of the e CAMP intervention for improving mental well-being and reducing depressive symptoms among young adolescents.

Primary Research Question

1. Does the e-CAMP intervention significantly reduce depressive symptoms among students, as measured by the Patient Health Questionnaire-9 (PHQ-9)? Secondary Research Questions
2. To what extent does the e-CAMP intervention enhance mental health knowledge and literacy among adolescents, as assessed by the Chinese-version Universal Mental Health Literacy Scale for Adolescents (UMHL)?
3. How does participation in the e-CAMP intervention impact students' smart device usage behaviors, as measured by the Smartphone Addiction Scale (SAS)?
4. Does the e-CAMP intervention effectively reduce sedentary behavior and increase total physical activity, as measured by the Global Adolescent and Child Physical Activity Questionnaire (GAC-PAQ) and smartwatch data?
5. How do participants and teachers perceive the applicability, acceptability, and sustainability of the e-CAMP intervention, based on survey and in-depth interview feedback guided by the RE-AIM framework?

Method : A prospective cluster RCT with two arms according to the cluster CONSORT 2010 checklist and guide [23] will be conducted. Eight eligible schools will be assigned randomly to the intervention or usual care group. The process evaluation will be guided by the RE-AIM framework [19-20]. Convenience sampling will be used to recruit eligible students ( about 320 ) from eight primary or secondary schools in Hong Kong. All schools are under Education Bureau of Hong Kong. The inclusion criteria will be students at participating schools who can read Chinese and are aged 11-15 (P5 to F2), with parental consent. Students with known physical (musculoskeletal) or cognitive/mental problems that would compromise physical exercise or our intervention or outcomes will be excluded.

experimental group ( e-CAMP mobile app 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.

Control group : Participants in control schools will receive usual school care, a 45-minute health talk delivered by a nurse. A PowerPoint handout will be provided to all participants after the health talk.

Study Overview

• Status: Not yet recruiting
• Conditions: Mental Health; Depression and/or Anxiety in the Mild-to-moderate Range
• Intervention / Treatment: Device: mobile app group; Behavioral: Control Group :health talk and usual care by school

Detailed Description

Mental health during adolescence is a major public health concern with profound long term population health implications. A person's lifelong physical, psychological, and social well-being are established during this crucial developmental period. Estimating that approximately 15% of adolescents aged 10-19 years present with mental disorders, most commonly depression, the World Health Organization (WHO) has identified adolescent mental health promotion as a global public health priority [1]. Adolescent depression is associated with persistent mental health problems, impaired psychosocial functioning, and increased morbidity in adulthood [1-3,5].In Hong Kong, the mental health burden on children and adolescents recently has intensified markedly. During 2020-2024, more than 130 school aged children died by suicide, and the adolescent (age: 10-19) suicide rate reached 7.2 per 100,000 [2,3,8]. Diagnoses of depression, anxiety, and related mental health conditions increased substantially among primary and secondary school students during the 2024/25 school year (vs 2019/20) [2-3]. These alarming trends emphasise the need for effective and preventive population based mental health promotions.

Excessive smart device use is a key modifiable adolescent mental health behavioural risk factor. Empirical evidence links smartphone addiction with sedentary behaviour, unhealthy dietary patterns, and increased depressive symptoms [1,2,4-9,18,35]. Prolonged screen time contribute to established risk factors for physical and mental health problems during adolescence, including physical inactivity and unhealthy lifestyles. Local data indicate that 50.7% of Hong Kong adolescents do not meet the WHO recommendation of ≥60 minutes/day of moderate to vigorous physical activity [2,17,38]; thus, integrated health promotion approaches are needed to address behavioural determinants of mental well-being [1,3,7-9].

Aims: To evaluate the effectiveness, user perception, and applicability of the e CAMP intervention for improving mental well-being and reducing depressive symptoms among young adolescents.

Method: A prospective cluster RCT with two arms according to the cluster CONSORT 2010 checklist and guide [23] will be conducted. Eight eligible schools will be assigned randomly to the intervention or usual care group. The process evaluation will be guided by the RE-AIM framework [19-20].

Significance:

The cluster RCT design combined with implementation evaluation will generate locally relevant evidence to inform future digital mental health promotion strategies in school settings.

At the community and population levels, the project will offer a scalable, cost-effective model combining a mobile health intervention with a standardised school-based health talk, enabling broad school coverage. By evaluating user perception, applicability and sustainability, the study will move beyond efficacy to inform real-world applications.

The findings will provide actionable evidence for schools, healthcare professionals, and policymakers to support early preventive mental health promotion strategies responsive to the needs of Hong Kong adolescents

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eliza ML Wong, PhD; Phone Number: 6803 852-3468-6803; Email: elizawong@twc.edu.hk
• Study Contact Backup: Name: Alan HL Tam, PhD; Phone Number: 9306 852-3943-9306; Email: hltam@cuhk.edu.hk

Study Locations

• China
  • Hong Kong
    • Hong Kong, Hong Kong, China, 00
      • Tung Wah College
      • Contact: Eliza ML Wong, PhD; Phone Number: 6803 852-34686803; Email: elizawong@twc.edu.hk
      • Contact: Alan HL Tam, PhD; Phone Number: 9306 852-3943 9306; Email: hltam@cuhk.edu.hk
      • Sub-Investigator: Anson CY Tang, PhD
      • Sub-Investigator: Simon C Lam, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The inclusion criteria will be students at participating schools who can read Chinese and are aged 11-15 (P5 to F2), with parental consent.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental : app group; 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: Facts and risk factors for depression in adolescents.; Depressive signs, symptoms, and care.; Strategies/tips for promoting well being (healthy diet, exercise, balanced use of smart devices and social media).; Stress management and substance abuse avoidance.; 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; 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.
Active Comparator: control group : face to face health talk; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mental health literarcy by The Chinese-version UMHL for adolescents	The Chinese-version UMHL for adolescents is a 17-item questionnaire evaluating the mental health literacy of adolescents aged 10-14; it encompasses five elements: recognition, knowledge of risks, treatment/ care, help seeking attitudes/stigma, and help seeking skill . It has good psychometric properties, with Cronbach's alpha coefficients of 0.80 and 0.78, respectively, for subscales.	4 months
Change in amart phone addiction (SAS)	The SAS-Short Version (Chinese version) will be used to measure smartphone addiction or use. This 10-item scale is rated using a 6-point Likert scale (1-6), with summed scores of 10-60, and measures daily life disturbance, withdrawal, cyberspace-oriented relationships, and overuse. Scores of 10-30, 31-40, and 41-60 indicate normal use, moderate and severe addiction respectively. Total smartphone usage will also be recorded. The scale has good psychometric properties, with a Cronbach's alpha of 0.91 and sensitivity and specificity ranges of 0.87-0.88 and 0.89-0.89, respectively	4 months
Change in exercise behaviour by Global Physical Activity Questionnaire (GPAQ)	Responses to the Global Physical Activity Questionnaire (GPAQ) will be converted to time spent on vigorous-intensity and moderate-intensity activity and Metabolic Equivalent Task minutes per week (MET-min/week) according to the GPAQ scoring guide. Total minutes of vigorous-intensity, moderate-intensity, and travelling activity in a typical week will be multiplied by 8.0, 4.0, and 4.0, respectively. Participants will be classified as having adequate moderate-to-vigorous physical activity (MVPA) if they accumulate at least 60 minutes of MVPA per day The total exercise time per week (METs) will also be obtained	4 months

Collaborators and Investigators

• Sponsor: Tung Wah College
• Collaborators: Chinese University of Hong Kong; Hong Kong Metropolitan University
• Investigators: Principal Investigator: Eliza ML Wong, PhD, Tung Wah College

Study record dates

Study Major Dates

• Study Start (Estimated): August 3, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: depression; mental health; adolescents; AI; mobile application; programme
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Personal Satisfaction; Depression; Psychological Well-Being
• Other Study ID Numbers: HMRF2026_TMP17526

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: the plan can be in due course after completion of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No