Clinical Research Directory

Trauma Exposure and Suicidal Behaviors in Adolescents Aged 11-17 Hospitalized in Child and Adolescent Psychiatry

It is a comparative monocentric study with longitudinal follow-up at 6 months in adolescents aged between 11 years and 17 years inclusive admitted to complete hospitalization either for suicidal behaviors or for other psychiatric causes. The objective is to explore the experiences of hospitalized adolescents regarding hospitalization, as well as their perceptions of the factors involved in their remission and their experience of the traumatic event(s) if they have been exposed.

Pilot Study on Follow-Up of (Acutely) Suicidal Individuals From the Flemish Suicide Helpline

This pilot study aims to assess the acceptance, feasibility, and added value of follow-up calls at the suicide helpline, Zelfmoordlijn 1813, in Flanders (Belgium). It serves as a crucial preparatory step in the development and implementation process of the callback methodology at Zelfmoordlijn 1813.

Design and Feasibility of an SMS-based Safety Planning Intervention

This study is testing whether it is feasible to run a larger randomized controlled trial and whether an automated text messaging program is acceptable to young adults who have suicidal thoughts. The program is designed to help participants create and use a safety plan, which is a personalized list of warning signs, coping strategies, supportive people, professional resources, ways to make their environment safer, and reasons for living. After joining and completing an initial survey, participants are randomly assigned by a computer to one of two groups. One group starts right away with the interactive safety planning text program. The other group first receives simple text messages with 24/7 crisis resources and then, after four weeks, also receives the interactive safety planning program. Participants use the text program for about four weeks and complete online surveys at the start and again over a total period of 24 weeks.

HIV Suicide Prevention With AI-DBT

One in four older persons living with HIV/AIDS (PLWHA) report at least one suicide attempt in their lifetime, and the risk for death by suicide is 100 times higher in PLWHA than in the general population. Currently, there are no behavioral interventions that specifically address suicide prevention for older PLWHA, despite their unique biopsychosocial and structural risk factors. Through this work, investigators will adapt Dialectical Behavior Therapy, an evidence-based intervention for suicide prevention, for patients with PLWHA to be delivered by an AI-powered conversational Agent developed by our industry partner, Empower Health. Investigators will then pilot test the feasibility, usability, acceptability and preliminary efficacy to improve self-efficacy to manage negative emotions in n=50 older adults living with HIV/AIDS.

Stepped-Care for Suicidal Youth and Children

The goal of this RCT study is to test the efficacy of a stratified stepped-care (SSC) model in reducing suicidal thoughts and behaviors (STB) in children and adolescents. The main questions it aims to answer are: 1. Does the SSC model effectively reduce STB and mental health symptoms? 2. Can the SSC model improve access to treatment and be cost-effective? Researchers will compare the SSC model to Care as Usual (CAU). The SSC model includes low-intensity counseling delivered by non-specialists for mild STB and professional-delivered therapy for more severe cases. The CAU group will receive standard clinic treatment, which consists of a waitlist for brief therapy and follow-up. Participants will be recruited from a clinic at Schneider Children's Medical Center, randomly assigned to either the SSC group or the CAU group, and Complete assessments at the start of the study and at 1, 3, and 6 months.

Pilot Trial of an Emotion Regulation and Executive Functioning Intervention for Self-Injurious Thoughts and Behaviors (SITBs) in Children

The goal of this study is to develop and test an outpatient intervention for preadolescents (ages 7-12) with self-injurious thoughts and behaviors (SITBs). The main questions it aims to answer are: 1. Does the newer intervention lead to better engagement of families in treatment compared to treatment as usual (TAU)? 2. Is the new intervention feasible, acceptable, and appropriate? 3. Does the new intervention lead to more improvements in SITBs, mental health symptoms, and treatment targets compared to TAU? Preadolescent participants with SITBs and their families will be randomized to either the new intervention or TAU, which will consist of the typical interventions the study therapist would use for preadolescents with SITBs. Participants will: 1. Complete an initial baseline assessment to determine eligibility and assess SITBs, mental health symptoms, executive functioning, and emotion regulation 2. Participate in a \~weekly, outpatient intervention lasting around 3-4 months 3. Complete additional assessments at mid-treatment, post-treatment, and 3-month follow-up 4. Participate in an interview sharing their perceptions of the intervention

Effects of a Multifaceted School-Based Intervention to Protect Mental Health and Prevent Suicidal Behaviour in Adolescents in Spain

What is this study about? This study aims to find out if a school-based program can help improve mental health and prevent suicidal thoughts and behaviors in teenagers in Spain. Suicide is one of the leading causes of death among young people. Many teens who think about or attempt suicide are also struggling with mental health problems like depression. Schools offer a unique opportunity to help because almost all adolescents attend school regularly. What will happen in the study? The study will include about 2,280 students aged 12 to 16 years from 38 secondary schools in the Balearic Islands, Spain. Schools will be randomly assigned to one of two groups: Intervention group: Students will participate in four weekly classroom sessions led by trained psychologists. These sessions will help students learn about mental health, manage their emotions, recognize signs of distress in themselves or others, and ask for help when needed. At the same time, parents and teachers will follow a digital training program with videos and resources to help them support students' mental health and recognize warning signs. Control group: Students will receive a minimal intervention, which includes educational posters displayed in classrooms. What is the purpose of this program? The main goal is to reduce suicidal thoughts and behaviors. The program also aims to improve students' overall mental well-being, reduce depression symptoms, and encourage help-seeking behaviors. It also helps parents and teachers feel more confident in supporting teens who may be at risk. How will the study be evaluated? Students will complete questionnaires at the start of the study and again after six months. These surveys will ask about mental health, suicidal thoughts, emotional well-being, self-harm, substance use, and experiences with bullying. Parents and teachers will also complete surveys about their knowledge and confidence in supporting students. Why is this study important? There is an urgent need to find effective ways to prevent suicide and support young people's mental health. This program involves students, families, and schools in working together to create a safe and supportive environment. If the program works, it could be used in schools throughout Spain and possibly in other countries too. Who is funding this study? The study is funded by Fundación Mutua Madrileña.

RomSi: Mobile Health Intervention to Enhance Suicide Prevention by Reducing Stigma and Increasing Literacy

Suicide is one of the leading causes of death in Spain, representing a public health crisis that requires urgent and effective solutions. The stigma surrounding suicide prevents many at-risk individuals from seeking help, worsening the problem. Addressing this stigma is essential to implement more effective and accessible prevention strategies. This study aims to design and evaluate an innovative mobile health intervention to reduce stigma and encourage help-seeking behaviours in the general population. While the intervention targets the general population, two specific groups will access specialized and tailored content: individuals with low suicidal ideation and family members or close friends of people who have died by suicide. Ecological Momentary Assessments (EMA) will collect real-time data and evaluate the intervention's impact. The study will employ a randomised controlled trial (RCT) with a crossover design, with participants randomly assigned to immediate or delayed use conditions. The intervention's effectiveness and usability will be assessed at four key points through quantitative analyses and qualitative interviews. We hypothesise that the intervention will improve suicide literacy, reduce suicide-related stigma, increase help-seeking behaviours, and demonstrate high usability and acceptability.