Villefranche De Roue, France

Get ActivE Study for At-risk Youth

Aim 3 (Randomized Pilot): To examine implementation outcomes, initial effectiveness, and equity across outcomes in a pilot randomized trial (n=75, 2:1 randomization, 35% Black, 10% Hispanic) of GET ActivE vs. Activity Monitoring Alone. H3a. The study will observe high GET ActivE feasibility (50% of eligible youth approached will enroll; completion >50%; attrition <20%; response to health coach contacts >80%); acceptability (>80%); and appropriateness (>80%). H3b. Youth who receive GET ActivE will show greater improvement in anhedonia (primary outcome) and H3c. depression severity and suicidal risk (secondary outcomes). H3d. Outcomes will be equitable by race. H3e. Exploratory (mechanistic): GET ActivE will lead to decreased depression and suicidal risk through increased activity and reward responsiveness.

Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making

Internet-delivered Emotion Regulation Individual Therapy or Adolescents (IERITA) with Self-injury Within Child and Adolescent Mental Health Services: Pilot Study

Self-injury without the intention to die is a growing and urgent global health crisis among youth. It is associated with substantial individual and societal costs, including increased risk of suicide attempts. Scalable and evidence-based treatments are needed but lacking. Digital interventions can be one promising solution. A recent study shows that a novel brief digital treatment, IERITA, can be efficacious compared to treatment as usual only. However, not all respond sufficiently to standardized treatment, such as IERITA, and continued self-injury entails risks and suffering. In this randomized controlled pilot trial, participants will be randomly allocated (1:1) to standard IERITA or adaptable IERITA. All participants will first receive standard IERITA for four weeks. In treatment week four, non-remission will be predicted. Adolescents allocated to adaptable IERITA and classified as likely non-remission, will change to adapted IERITA for the remaining eight weeks while all other participants will continue standard IERITA. Data will be collected pre-treatment, during treatment, post-treatment, one- three- and twelve-month post-treatment. The primary endpoint is one-month post-treatment. The main objective is to investigate the project's feasibility and test key components. The specific objectives are: 1. Examine the feasibility of the project (treatment satisfaction and adherence, degree of participation in data collection, and level of resources). 2. Explore the utility of adapted IERITA compared to standard IERITA for adolescents at risk of non-remission. 3. Evaluate the performance of the algorithm predicting treatment non-remission. This project is sponsored by the Swedish Research Council for Health, Working life, and Welfare (number 2024-01916)

NIMH Clinical Pathway in Rural Appalachian School-based Health Clinics

Co-creation of Tools for Children and Adolescents with Suicidal Thoughts And/or Behaviour

Efficacy-Implementation Study for PC CARES in Rural Alaska

AIM#1 will assess how (and if) our intervention engages the presumed proximal mechanisms of change: personal (self-efficacy) and collective (CoP) resources and skills (including knowledge) as well as distal outcomes (engagement in suicide prevention behaviors) to address suicide in the participants' own community. Using a multilevel growth model, we examine the changes in proximal outcomes of suicide prevention knowledge, self-efficacy, collaborations for a 'community of practice' (CoP), and distal outcomes of prevention-oriented behaviors of adult PC CARES participants (n=250) over time (7 timepoints), testing for moderating effects of dosage (e.g. #LCs attended), community 'readiness'; cross-sector participation on outcomes to inform future PC CARES implementation (AIM#1). Inclusion criteria for participants in Aim#1 are ages 18 and older who participated in PC CARES learning circles. AIM#2 focuses on diffusion of learning in six randomly selected communities over the same time period as the first aim. The recruitment criteria for participating in this community-wide data collection is to be a resident of the community and age 12 years or older (youth: ages 12-17, and adults: 18 and older). Our community-wide adult and youth measures assess the community-level mechanisms of change (social diffusion), and track youth outcomes. We hypothesize that PC CARES learning circles will encourage adults to develop collaborative relationships within a CoP to implement upstream suicide prevention best practices (SPBPs) in support of youth in their lives. Using community level social network measures, we document the number and type of interactions reported by adults (n=450) over time, capturing social diffusion by comparing the knowledge, self-efficacy, CoP and prevention-oriented behaviors of (1) PC CARES participants, (2) non-participants who are 'close to' participants and (3) others, unrelated to participants (comparison group). In both the Adult and Youth Follow-up Surveys, we characterize closeness (close associates/youth 'close to' participants versus unrelated adults and youth) by asking respondents (Y/N) if they are close to a list of PC CARES participants from their community (i.e. people who attended 4+ LCs). 'Close to' is defined as someone with whom the participant feels closely connected to and interacts with at least weekly. To assess youth impact (n=300, ages 12-17), we measure youth-reported supportive adult interactions and connectedness (over 7 time points), and pre-post perceived social support, family and community protective factors, comparing outcomes for youth who are 'close to' LC participants versus 'unrelated' youth (comparison group). AIM#3 combines community-engaged methodologies and evidence-based implementation science frameworks to examine the barriers and enablers of PC CARES implementation in Alaska Native communities. AIM#3 examines implementation outcomes and contextual determinants to further understand how to successfully support community-driven diffusion of SPBPs in extremely rural and remote AN villages. Our evaluation will blend PC CARES' community-engaged approach with two evidence-based and widely used Implementation Science (IS) frameworks (RE-AIM; CFIR 2.0). Using participatory methods, we will sequentially and iteratively seek insights from our community partners, including: Rural Human Service (RHS) Students, RHS instructional teams (Elders; University of Alaska Fairbanks (UAF) Practicum Faculty, mentors), and Community Steering Committee (CSC) members. All RHS student facilitators will be invited to participate in each stage of research, and if interested will be invited to join the Community Steering Committee (CSC). As the RHS student facilitation teams implement LCs as part of their practicum, biweekly zoom/phone calls will support and track RHS student experiences and insights and offer opportunities for peer and mentor support. Monthly written reports will capture each student's community-based actions (e.g., recruitment process, sharing ideas from LCs with the tribal council), their experience of hosting LCs, including 'what worked' (enablers) and implementation barriers. In these various ways, they will reflect on key contextual determinants they are navigating, and how those affect their implementation of PC CARES. Lessons learned or puzzling findings from each of 5 RHS cohorts will be shared with the LSC to gain further insights and to inform the next wave of data collection and analysis. After each wave of implementation, we will conduct focus groups with RHS student facilitators about their overall experience using semi-structured guides informed by our preliminary RE-AIM outcomes (Reach, Effectiveness, Diffusion, Adoption, Implementation and Maintenance). We will transcribe focus groups recordings verbatim and use Dedoose, a qualitative analytic software, for deductive analysis using the RE(D)-AIM construct structure.

Real-time Examination of Skills and Coping Use in Teen's Everyday Lives

Suicide marks an extreme along a continuum of self-inflicted injury (SII) and is a leading cause of death among adolescents. Although psychologists have evidence-supported interventions for youth SII, the biosocial mechanisms supporting change are underexplored. Lack of innovation in this area has led to statis, rather than decline, in population-level suicide rates. The field also lacks vital data on: if/when adolescents apply therapeutic skills in daily life, the neural and physiological factors influencing skill uptake, and whether such skills are effective in reducing SII and related risk and vulnerability factors. When identifying key intervention targets, theoretical and empirical work implicate emotion dysregulation and interpersonal stressors in SII etiology and maintenance. Adaptive emotion regulation strategies and strong social ties each reduce the likelihood of suicidal ideation and SII among otherwise vulnerable individuals, and improvements in emotion regulation are associated with SII cessation. Yet, the specific skills and mechanisms promoting self-regulatory improvements are not well understood. This study is designed to rigorously examine two competing SII intervention mechanisms. The research plan and aims are devoted to identifying youth who may benefit from a brief skill-building intervention and biosocial mechanisms supporting skill acquisition. The investigator use a within-subjects design to directly compare the effects of teaching an intra- vs. interpersonal skill from Dialectical Behavior Therapy (DBT; a widely-used intervention for SII). Adolescents with a history of repeated SII (n = 100) will participate in 4 laboratory visits with a primary caregiver. At Visit 1, participants will complete interviews and questionnaires assessing psychiatric diagnoses, SII, and life stress, and 50 will complete two functional MRI paradigms to tap neural processes underlying perspective taking and empathy, and approach/avoidance. Adolescents will then complete a 2-week EMA protocol (EMA1, Training Aim 2) to measure daily affect, perceived stressors, SII, and suicidal thoughts, pre-intervention. At Visit 2, dyads will be randomly assigned to learn and practice GIVE (interpersonal skills training) or opposite-to-emotion action (OA; intrapersonal skill). The investigator will assess behavioral, affective, and physiological regulatory processes (respiratory sinus arrythmia [RSA]) during two conflict discussions: (1) pre- skills training, and (2) post-training, while dyads use their assigned skill. This laboratory assessment will be followed by a second EMA period (EMA2) to assess skill use and EMA1 variables. Post EMA2, dyads will return for Visit 3 to repeat fMRI assessment before undergoing training in the alternate skill ⎯ followed by another 2-week EMA protocol (EMA3). Finally, participants will complete a remote follow-up visit 6 months post-EMA3, where the investigator will reassess SII, symptom severity, and life stressors as well as barriers to skill use. This study will assess and integrate multimodal responses to core intervention mechanisms in a high-risk sample. Aim 1: Examine within-person mechanistic (brain, RSA) changes as a function of skills training in the laboratory (Training Aim 1). H1a: Participants will show less RSA withdrawal during skill-practice relative to a pre-training conflict task. H1b: Such intervention changes will translate to increased left ventro-lateral prefrontal cortex engagement during an fMRI paradigm tapping OA; and increased medial pre-frontal cortex engagement during a task tapping perspective taking and empathy (corresponding to GIVE). H1c: Compared with the OA condition, GIVE training will result in less RSA withdrawal during skills practice. H1d: The investigator will test whether skill practice effects (H1a, b) are moderated by recent life stressors (Training Aim 3) and expect severe stressors in the 6 months preceding study participation will be associated with less improvement during skills practice across outcome measures. Aim 2: Examine the effects of skills training on outcomes relevant to suicide risk in daily life. H2a: Changes observed post-skills training in the GIVE and OA conditions will extend into social and affective improvements in participants' daily lives as reported via EMA - especially in the context of momentary skills use. H2b: Further, the investigator hypothesize that skill use during laboratory visits and EMA will predict subsequent reductions in life stressors that are dependent on adolescent characteristics and/or behaviors. Aim 3: Examine persistence/decay effects of skill in daily life following initial skill exposure and a "booster" call. H3a: Skill use will be most frequent immediately following training and decline over time. H3b: A brief booster call 1 week post-skill exposure will predict increases in EMA reported skill use. The investigator will examine potential moderation effects to determine who may benefit from repeated skill exposure. H3c: Youth skill use over the EMA period will predict changes in stressor severity experienced over 6-month followup. Specifically, GIVE use will predict less severe dependent stress.

Syncing Screening and Services for Suicide Prevention Across Health and Justice Systems

This study is designed to test the effectiveness of a care pathway delivered at the time of jail release, to increase behavioral health services engagement and prevent suicide attempt. There are 3 primary aims of this study: (1) Examine the effectiveness of the intervention on suicide attempt outcomes. (2) Evaluate the impact of the intervention on behavioral health utilization mechanisms. (3) Evaluate implementation outcomes and processes to guide future implementation and research, including: cost and cost-effectiveness; scalability; sustainability; feasibility, acceptability, and appropriateness to providers/systems; and implementation strategies.

Open Pilot Trial Evaluating an Avatar-Guided Intervention for Emerging Adults With Alcohol Use Problems and Suicide Risk

This study is an open pilot usability trial with emerging adults presenting to the emergency department with binge drinking and suicidal thoughts. The main study aims are to test the usability of a newly developed avatar-guided mobile health intervention and feasibility of 28 days of daily assessments and four follow-ups at 4-, 8-, and 12-weeks after discharge. Ten emerging adults aged 18-29 years old will be recruited from the emergency department who have suicidal ideation and alcohol use problems. Exclusion criteria are conditions that would preclude research participation (e.g., cognitive disabilities, in police custody; at imminent risk of harming oneself in the emergency department). All ten participants will be given access to a newly designed avatar-guided digital intervention and text message intervention (EA-Avatar) for 12 weeks in addition to usual emergency department care. Participants will complete measures of alcohol use, suicidal ideation, and alcohol-related cognitions and experiences, as well as service utilization. They will also complete a scale of usability of the avatar intervention and qualitative interviews of the intervention and research protocols. Based on participant qualitative interviews, a scale of usability of the digital intervention, feedback surveys, recruitment and retention in the study, participant completion of daily diary and ecological assessment surveys, and analysis of mobile intervention usage data, the intervention will be revised, before testing in a larger randomized controlled feasibility trial.

Nitrous Oxide in the Treatment of Acute Suicidal Ideation