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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 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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

Tipo de estudio

Intervencionista

Inscripción (Estimado)

300

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Eliza ML Wong, PhD
  • Número de teléfono: 6803 852-3468-6803
  • Correo electrónico: elizawong@twc.edu.hk

Copia de seguridad de contactos de estudio

  • Nombre: Alan HL Tam, PhD
  • Número de teléfono: 9306 852-3943-9306
  • Correo electrónico: hltam@cuhk.edu.hk

Ubicaciones de estudio

    • Hong Kong
      • Hong Kong, Hong Kong, Porcelana, 00
        • Tung Wah College
        • Contacto:
          • Eliza ML Wong, PhD
          • Número de teléfono: 6803 852-34686803
          • Correo electrónico: elizawong@twc.edu.hk
        • Contacto:
          • Alan HL Tam, PhD
          • Número de teléfono: 9306 852-3943 9306
          • Correo electrónico: hltam@cuhk.edu.hk
        • Sub-Investigador:
          • Anson CY Tang, PhD
        • Sub-Investigador:
          • Simon C Lam, PhD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
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.
Comparador activo: 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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
change of depression scoreby Patient Health questionnaire (PHQ9 )
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in mental health literarcy by The Chinese-version UMHL for adolescents
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Eliza ML Wong, PhD, Tung Wah College

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

3 de agosto de 2026

Finalización primaria (Estimado)

31 de julio de 2027

Finalización del estudio (Estimado)

31 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

10 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

10 de julio de 2026

Publicado por primera vez (Actual)

15 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • HMRF2026_TMP17526

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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