Effect of a Programme Including an AI-enhanced Mobile Application on the Mental Well- Being of Young Adolescents in Hong Kong (AI-eCAMP_RCT)
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.
調査の概要
状態
詳細な説明
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
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Eliza ML Wong, PhD
- 電話番号:6803 852-3468-6803
- メール:elizawong@twc.edu.hk
研究連絡先のバックアップ
- 名前:Alan HL Tam, PhD
- 電話番号:9306 852-3943-9306
- メール:hltam@cuhk.edu.hk
研究場所
-
-
Hong Kong
-
Hong Kong、Hong Kong、中国、00
- Tung Wah College
-
コンタクト:
- Eliza ML Wong, PhD
- 電話番号:6803 852-34686803
- メール:elizawong@twc.edu.hk
-
コンタクト:
- Alan HL Tam, PhD
- 電話番号:9306 852-3943 9306
- メール:hltam@cuhk.edu.hk
-
副調査官:
- Anson CY Tang, PhD
-
副調査官:
- Simon C Lam, PhD
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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:
|
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.
|
|
アクティブコンパレータ: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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
change of depression scoreby Patient Health questionnaire (PHQ9 )
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in mental health literarcy by The Chinese-version UMHL for adolescents
時間枠: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)
時間枠: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)
時間枠: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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Eliza ML Wong, PhD、Tung Wah College
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。