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Effect of a Programme Including an AI-enhanced Mobile Application on the Mental Well- Being of Young Adolescents in Hong Kong (AI-eCAMP_RCT)

15. Juli 2026 aktualisiert von: Eliza Wong, Tung Wah College

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

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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

Studientyp

Interventionell

Einschreibung (Geschätzt)

300

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China, 00
        • Tung Wah College
        • Kontakt:
        • Kontakt:
        • Unterermittler:
          • Anson CY Tang, PhD
        • Unterermittler:
          • Simon C Lam, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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:

  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.
Gerät: 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.
Aktiver Komparator: 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.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
change of depression scoreby Patient Health questionnaire (PHQ9 )
Zeitfenster: 4 months
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in mental health literarcy by The Chinese-version UMHL for adolescents
Zeitfenster: 4 months
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)
Zeitfenster: 4 months
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)
Zeitfenster: 4 months
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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Tung Wah College

Mitarbeiter

Chinese University of Hong Kong
Hong Kong Metropolitan University

Ermittler

  • Hauptermittler: Eliza ML Wong, PhD, Tung Wah College

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

3. August 2026

Primärer Abschluss (Geschätzt)

31. Juli 2027

Studienabschluss (Geschätzt)

31. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

10. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Juli 2026

Zuerst gepostet (Tatsächlich)

15. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • HMRF2026_TMP17526

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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