Clinical Research Directory

Evaluation of an App for Young People With Suicidal Thoughts

There are currently very few evidence-based tools specifically designed to support children and adolescents experiencing suicidal thoughts. Digital interventions are increasingly used in suicide prevention and show promise in helping young people improve emotional regulation, coping skills, and manage suicidal thoughts and behaviors. In Flanders, the app BackUp was developed in 2015 by VLESP to support adults with suicidal thoughts. Research showed that while the app led to a small, non-significant reduction in suicidal thoughts after one week, 70% of users found it helpful in daily life. A key feature of the app is the Safety Plan, based on cognitive behavioral therapy, which helps individuals identify coping strategies and sources of support. This approach has proven effective in reducing suicidal behavior and is also suitable for use with children and adolescents. Despite these developments, there is still a need for a digital tool specifically tailored to young people. In 2023, the investigators launched a project to develop a new app in collaboration with youth care professionals, app developers, and adolescents with lived experience of suicidality. Their input ensures the app meets the needs and preferences of young users. This study aims to evaluate the effectiveness and usability of the app through a pilot study involving adolescents aged 12-17 who are currently experiencing suicidal thoughts. Participants and their parents or guardians must provide informed consent before joining the study. The evaluation includes online questionnaires completed before and after using the app. These questionnaires collect information on demographics, coping strategies, and the severity of suicidal thoughts and behaviors. The post-assessment also includes questions about user experience and satisfaction. No interviews are conducted; all data are collected digitally. Participants are recruited through various channels and must meet specific inclusion criteria. After completing the initial questionnaire, they receive a code to access the app, ensuring that only study participants can use it.

Little ACF (Lilla ABC): Evaluation of a Parental Support Program for Parents of Children Aged 1-2 Years

Society can promote children's mental health at an early stage by creating good conditions with, for example, general parental support programs that are offered to all parents. One program that has been developed is called All Children in Focus (ACF) \[in Swedish: Alla Barn i Centrum (ABC)\] which has been evaluated for parents with children aged 3-12 years. The results showed effects on parenting ability, parenting strategies and on children's well-being. Staff in child health care (CHC), a natural arena for parental support programs reaching almost all families, have requested modifications in the program ACF to involve parents with younger children. The parent groups offered within CHC today are not evaluated in younger children and could be thus replaced by researched parental support based on evidence. The investigators therefore want to study the effects of a modified version of ACF for parents of children 1-2 years (Little ACF) to see if Little ACF can strengthen parenting ability and have effects on children's social and emotional development. Parents within CHC are asked to participate and are randomly assigned to Little ACF or the regular CHC program plus a lecture. Little ACF is offered during four group meetings and potential effects are measured with questionnaires. Measurements are made before randomisation, during and after participation in Little ACF. Children's behavior is followed up at 3 years through questionnaires and CHC documentation. The study can provide important knowledge about how Little ACF can promote children's mental health and strengthen parents. The investigators see it as a strength that Little ACF is based on research and on dialogue with parents and professionals. Little ACF, which is aimed at everyone, can form a basis for identifying families and children who need preventive and treatment measures.

Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico

The overall goal is to identify trends and longitudinal associations in psychosocial, food-related, and cardiometabolic risk factors that can guide public health priorities and future research needs aimed at reducing cardiovascular-related disparities in Puerto Rico. To this end, investigators will establish 'PROSPECT: Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic disease Trends', an island-wide, longitudinal population cohort of 2,000 adults (30-75 years) in PR recruited with a community-wide sampling strategy, and assessed in a network of several partner clinics across the island. The study will collect comprehensive data on multiple psychosocial, dietary, and food-related factors, CVD biological markers, and medical record data, with follow-up at 2-years, and will assess variations by urban-rural area and by timing before-after Maria.

Coping and Attachment in Pediatric Oncohematology

Cancer can be a traumatic and particularly salient experience in a person's history. The ways in which the pediatric patient copes with it depend on the interaction of several factors present in his or her life context, primarily the relationship that is established between parent and child. Despite the paucity of studies in the literature in this regard, it would seem that parental coping is predictive of child coping. Coping strategies represent the ways in which people try to manage traumatic events or stressful everyday situations. Currently, the literature identifies two main categories of coping strategies: emotion-oriented and problem-oriented strategies. The former are aimed on reducing stress-induced unpleasant emotions (e.g., problem avoidance, positive reappraisal, etc.); the latter, on the other hand, focus on stress dissolution/alteration (e.g., problem identification and resolution, stress cause research). Some studies, previously conducted in oncology, show that emotion-focused coping strategies are associated with better adaptation immediately after diagnosis, but their positive influence tends to weaken over time; problem-focused coping strategies are more correlated with poor adaptation immediately after diagnosis, but in the later stages of treatment. The clinical experience with patients in the Pediatric Oncohematology Department brings out the need to develop and structure a psychological assessment model, in order to ensure a more effective care of the family units followed. The research aims, through a single administration of psychological tests, to investigate the role of attachment and some variables (age, gender, stage of treatment, stage of the disease, social support, resilience, ability to adapt to environmental stimuli, emotional state of of caregivers) on the coping strategies implemented by the parents of patients and the patients themselves, in order to differentiate the types of psychological intervention, to try to reduce psychological distress and increase levels of mental well-being.

Intervention to Enhance Coping and Help-seeking Among Youth in Foster Care

This study will deploy a scalable secondary prevention program that leverages existing foster youth transition services to improve mental health functioning and service use before and after exiting foster care. Our short-term objective is to remotely test a group intervention called Stronger Youth Networks and Coping (SYNC) that targets cognitive schemas influencing stress responses, including mental health help-seeking and service engagement, among foster youth with behavioral health risk. SYNC aims to increase youth capacity to appraise stress and regulate emotional responses, to flexibly select adaptive coping strategies, and to promote informal and formal help-seeking as an effective coping strategy. The proposed aims will establish whether the 10-module program engages the targeted proximal mechanisms with a signal of efficacy on clinically-relevant outcomes, and whether a fully-powered randomized control trial (RCT) of SYNC is feasible in the intended service context. Our first aim is to refine our SYNC curriculum and training materials, prior to testing SYNC in a remote single-arm trial with two cohorts of 8-10 Oregon foster youth aged 16-20 (N=26). Our second aim is to conduct a remote two-arm individually-randomized group treatment trial with Oregon foster youth aged 16-20 with indicated behavioral health risk (N=80) to examine: (a) intervention group change on proximal mechanisms of coping self-efficacy and help-seeking attitudes, compared to services-as-usual at post-intervention and 6-month follow-up: and (b) association between the mechanisms and targeted outcomes, including emotional regulation, coping behaviors, mental health service use, and symptoms of depression, anxiety, and PTSD. Our third aim is to refine and standardize the intervention and research protocol for an effectiveness trial, including confirming transferability with national stakeholders.