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Not Yet Recruiting NCT07704996

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

Conditions: Mental Health, Depression and/or Anxiety in the Mild-to-moderate Range

Sex: All
Ages: 11 Years – 15 Years
Healthy volunteers: No
Phase: NA
Enrollment: 300
Sponsor: Tung Wah College

Location: Tung Wah College Hong Kong Hong Kong

Summary

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.

Eligibility Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07704996). StuddyBuddy aggregates publicly available trial information.