Clinical Research Directory

Mental Health Literacy and Help-Seeking Behavior Among Adolescents

This study examines mental health awareness and help-seeking behaviors among adolescents aged 13-18 years in Assiut City, Egypt. Mental health problems are common among young people, but many adolescents do not seek professional help when they need it. This is often due to low mental health literacy (not understanding mental health problems or knowing where to get help), stigma (negative attitudes toward mental illness), and fears about confidentiality or being judged. The study has two parts: Part 1 - Assessment Phase: Researchers will survey approximately 270 students from preparatory and secondary schools in Assiut to understand their current levels of mental health literacy, stigma, and willingness to seek help for mental health problems. Students will complete validated questionnaires that measure their knowledge about mental health, their attitudes toward peers with mental health problems, and their intentions to seek help from various sources. Part 2 - Intervention Phase: In a randomized controlled trial involving 150 students (75 in an intervention group and 75 in a control group), researchers will test whether a brief educational program can improve mental health literacy, reduce stigma, and increase help-seeking intentions. The intervention consists of three weekly classroom sessions covering: (1) mental health literacy - basic concepts, common problems in adolescents like stress and anxiety, recognizing symptoms; (2) stigma reduction - understanding how negative labels hurt people, recognizing public and self-stigma, using respectful language; and (3) help-seeking behavior - knowing when to seek help, understanding formal and informal help sources, overcoming barriers, and learning about local resources in Assiut. Students in both groups will complete questionnaires before the intervention and one month after completion. The control group will not receive the educational sessions during the study period. Researchers will compare changes in mental health knowledge, stigma levels, and help-seeking attitudes between the two groups to determine whether the program is effective. The study aims to address a critical gap in mental health services for adolescents in Upper Egypt by improving young people's understanding of mental health and encouraging them to seek appropriate help when needed.

Pilot Cluster RCT of an Indirect Contact Mental Health Literacy Program for 5th-Grade Students

This cluster-randomized pilot trial will evaluate the preliminary effects and feasibility of adding an indirect contact component to a school-based mental health literacy (MHL) lesson for 5th-grade students in a public elementary school in Tokyo, Japan. Four 5th-grade classes (approximately 150 students in total) will be randomized by class (two classes per arm). All students will receive a 45-minute lesson that includes an animated video and educational slides. In the intervention arm, teachers will additionally introduce a short story about a well-known soccer player who experienced and recovered from a mental health condition, serving as an indirect contact element. The control arm will receive the standard lesson without this component. Students will complete questionnaires at baseline (T1), immediately after the lesson (T2), and 2-3 months later (T3). The primary outcome is vignette-based social distance toward a peer with mental health problems. Secondary outcomes include mental health knowledge, help-seeking intentions, perceived need for help, intended sources of help. As a pilot study with only four clusters, the trial is not powered to detect small effects; findings will be used to estimate effect sizes and assess feasibility for a future larger-scale trial.

AI Chatbots for Anxiety Mental Health Literacy

The goal of this clinical trial is to examine whether AI-based chatbots can improve anxiety-related mental health literacy in adults with varying levels of anxiety. The study aims to learn whether interactive AI chatbots can improve understanding of anxiety, attitudes toward anxiety, help-seeking intentions, confidence in supporting others, and anxiety symptoms, compared with standard text-based educational materials. The main questions it aims to answer are: 1. Does an AI-based psychoeducation chatbot improve anxiety-related mental health literacy compared with text-based psychoeducation? 2. Does adding interactive anxiety simulation conversations further improve mental health literacy and related outcomes compared with psychoeducation alone? Researchers will compare participants who use an AI psychoeducation chatbot alone, participants who use an AI psychoeducation chatbot combined with anxiety simulation chatbots, and participants who receive text-based psychoeducation, to see whether the AI-based interventions lead to greater improvements in mental health literacy and related outcomes. Participants will: 1. Complete baseline questionnaires assessing anxiety-related knowledge, attitudes, and symptoms 2. Be randomly assigned to one of three groups: AI psychoeducation chatbot, AI psychoeducation chatbot plus anxiety simulation chatbots, or text-based psychoeducation 3. Use the assigned intervention over a one-week period 4. Complete follow-up questionnaires immediately after the intervention and at later follow-up time points

Promoting Mental Health of Teachers and Caregiver Using a Personalized mHealth Toolkit in Uganda

This study record describes a two-phase of clinical trial study. The first phase is a pilot study phase (to study feasibility and efficacy of the intervention), and the second phase is an effectiveness study phase (a fully powered evaluation study to test the intervention effectiveness). This proposal seeks to develop and test a new mHealth intervention, the mHealth Toolkit for Wellness \& Empowering Lives of School Community (mWEL) in Uganda. The mWEL-digial toolkit is a preventive intervention tool for teachers and parents as a self-help support modality. Caregivers who need support in navigating the toolkit will be supported by peer-community health workers (P-CHWs).

Cocreating Action to Improve Rationality in the Health System

Despite widespread recognition of social, economic, or environmental health determinants, health action remains heavily dominated by individual-level solutions (e.g., medication, patient counselling, vaccination). This study aims to stimulate changes in health system functioning by demonstrating how the cocreation of actions to address psychological well-being, cardiovascular health, and antimicrobial resistance from within the community can alleviate the burden on primary care services, reduce medicalisation and increase health equity. The scientific approach uses mixed methods and incorporates theory from multiple disciplines. This study will appraise how the current system addresses psychological well-being, cardiovascular (CV) health, and rational use of antibiotics using a population survey, a survey of patients collecting their medication at community pharmacies, aggregate health service indicators on medication consumption and primary care consultations, and qualitative methods exploring stakeholders' perceptions.The investigators will undertake community-based participatory research to engage citizen scientists in the cocreation of community-led actions to promote psychological well-being, CV health, and prevent antimicrobial resistance. The design, implementation, and evaluation of the actions will apply an assets-based approach and apply theories and frameworks from implementation science in an iterative manner over 3 years. Finally, the impact of the cocreated actions will be analysed, considering effectiveness and broader contextual issues such as initiative adoption, implementation, and maintenance. The investigators will use a before-after comparison of survey indicators, an interrupted time-series analysis of health service data and qualitative analysis. The goal is to demonstrate how the integration of community action with attention to the social determinants of health, can lead to a more rational approach to health care and ultimately improve health and health equity.

Non-inferiority of Virtual vs. Traditional Methods in Adolescent Mental Health Literacy

The goal of this clinical trial is to determine whether a digital psychological literacy program delivered by an AI-powered virtual agent is non-inferior to traditional teacher-led instruction in improving mental health literacy among adolescents. The study focuses on middle and high school students aged 11 to 18 years attending a school in Shanghai, China, including those with varying levels of emotional well-being but excluding those with diagnosed psychiatric disorders or severe physical illness. The main questions it aims to answer are: Is the virtual agent-delivered psychological literacy program as effective as teacher-led instruction in improving adolescents' mental health literacy? Does the virtual agent intervention lead to comparable or better outcomes in secondary measures such as depression, anxiety, psychological resilience, sleep quality, and digital well-being? Researchers will compare students receiving 6 weekly sessions from a virtual digital agent to students receiving the same curriculum delivered by trained psychology teachers to see if the AI-based approach achieves similar improvements in mental health knowledge, attitudes, and help-seeking behaviors. Participants will: Complete online assessments at baseline, week 3, week 6 and week 18 covering mental health literacy (UMHL-A), depression (PHQ-9), anxiety (GAD-7), psychological resilience (RSCA), and other well-being indicators Attend one 45-60 minute session per week for 6 weeks, either interacting with the virtual agent or participating in a teacher-led class Optionally take part in a brief satisfaction survey and/or a focus group interview after the intervention to share their experiences

Text-messaging Intervention to Support Parents After Their Child's Psychiatric Emergency

This grant aims to develop and test a text-messaging intervention for parents of children and teens evaluated in the emergency department for a psychiatric emergency and discharged home with outpatient referrals. The intervention for parents will teach parents skills to navigate the mental health services system and build their self-efficacy in managing their child's mental health. This research has the potential to improve services for families seeking emergency psychiatric support, with the goal of facilitating treatment engagement and reducing emergency services utilization using scalable, cost-effective, accessible tools.

Youth-for-Youth Mental Wellness Care and Action

This initiative aims to improve flourishing and quality of life of secondary school students, reduce mental distress (e.g., depression and suicidal ideation), enhance their understanding of mental health (e.g., mental health literacy) and help-seeking intention, and foster a supportive school environment (e.g., school climate-caring relationship, and sense of community). Also, this initiative aims to improve students' process of change in psychological (e.g., mattering, emotion regulation, empowerment) and social (e.g., trust belief) aspects and mental health awareness (e.g., mental health stigma). The feasibility, acceptability, and sustainability of the programme from multiple perspectives (e.g., students, student leaders, and stakeholders) will also be evaluated. In addition, the cost-effectiveness of delivering this programme (e.g., the incremental cost-effectiveness ratio (ICER)) among secondary schools in Hong Kong will be assessed. The programme will be implemented among students in 130 local secondary schools over three academic years. The first is a pilot phase (Year 1), which 40 schools will implement the intervention and student participants will be evaluated at pre- (T0) and post-intervention (T1) using questionnaires. In this stage, participatory research will be conducted before and after the intervention among students, student leaders, and stakeholders in 20 pilot schools to co-design the intervention, ensuring the programme meet the actual wellness needs of youth. In following two academic years, an additional 90 schools will participate in a cluster randomized controlled trial (RCT) with a 1:1 ratio between intervention and waitlist control groups. Each year, 45 schools will implement the intervention. Summative evaluation will be conducted among RCT schools at T0 and T1, and 3-month follow-up (T2). Quantitative data be collected to assess the effectiveness of intervention, and qualitative data will provide understanding of students' and stakeholders' perspectives of the intervention implementation. Cost outcomes will include intervention costs and cost savings, calculated from the payer (i.e., JC/government) perspective using administrative records or validated tools. The primary outcome of effectiveness will be the quality-adjusted life-years (QALYs) of students. Cost and QALYs will be used to evaluate the cost-effectiveness of the intervention, for example, estimate the incremental cost-effectiveness ratio (ICER).

Sanctuary Youth Series Randomized Control Trial

Sanctuary Mental Health Ministries designed an eight-week program for youth ages 11-15 that uses games, short films, discussion questions, and exercises to engage with mental health and faith topics. The intervention package includes a facilitation guide and a guide for parents and caregivers. The program is intended to be conducted by an experienced facilitator, although there is no specific training provided for facilitators outside of the facilitation guide. The facilitator would lead groups of 11-15 year olds by leading games, showing the films, and facilitating discussion. The series is freely available on Sanctuary's website; individuals can access the material by creating an account, logging in, and downloading the course content. This RCT is to evaluate the effectiveness of the Youth Series course on improving youth's mental health literacy, knowledge, and attitudes towards help-seeking.

Design, Implementation and Evaluation of an Intervention Within Video Game for Mental Health Literacy in Adolescents and Young Adults

Context Adolescence and early adulthood are crucial periods for the development and maintenance of habits, behaviors and beliefs favorable to health and mental well-being. These can have significant lifelong health consequences and social costs. In this age group, the Internet and smartphones are predominant. Based on these two observations, the project proposes to use the Internet, and more specifically, an online game, as a vector for public health intervention. Health literacy is recognized as a key determinant of health. It refers to the motivation and skills of individuals to access, understand, evaluate and use information to make decisions about their health. Improving the level of literacy is a major public health challenge if the population is to be in a position to take better charge of its health, particularly its mental health. Objective To evaluate the effect of a public health intervention on the development of mental health literacy in adolescents and young adults (15-25 years) delivered within an existing online community game. Research hypothesis Developing and delivering a (multicomponent) public health intervention in an original setting, such as the game Minecraft, to a community of adolescents and young adults will improve their mental health literacy and thus enhance the primary, secondary and tertiary prevention of mental health disorders. Methods The project's overall methodology is based on a multidisciplinary approach. A pilot phase has already enabled us to develop the theoretical framework and constituent elements of an intervention, as well as its acceptability and feasibility. Intervention We will conduct a pragmatic cohort multiple randomised controlled trial over 24 months. The chosen methodology will enable us to implement an intervention with different components. The intervention will involve: collective challenges of various kinds (component A) and exchanges with influencers of different profiles (component B). The control group will be offered access to conventional sources of health information and ""placebos"" of the components described above. The theme is mental health literacy, and the intervention delivered will equip the players (capacity-building, recognizing ill-being, warning signs, resources, etc.) to ultimately enable them to react better (empowerment) and thus promote young people's mental health. Evaluation The evaluation will follow the Medical Research Council's recommendations for the evaluation of complex interventions. It will consist of a process evaluation and an evaluation of effectiveness, all of which will be based on the use of mixed methods (observations of players receiving the intervention, analysis of chat exchanges made by players during the intervention, evaluation questionnaires and a standardized grid for collecting process indicators). The primary endpoint for the effect analysis is the mental health literacy score (global score) measured by the MHLq including four dimensions: (1) knowledge of mental health problems; (2) mistaken beliefs/stereotypes; (3) help-seeking and first-aid skills; and (4) self-help strategies. Perspectives The results of this research project will make it possible to 1) develop new relevant interventions on various health topics, using the results obtained for the different interventions carried out within Minecraft 2) Contribute to the evidence base on the effectiveness of Internet-based interventions.