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Suicide, Attempted clinical trials

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NCT ID: NCT04994873 Recruiting - Suicide, Attempted Clinical Trials

Skills to Enhance Positivity in Suicidal Youth

STEP
Start date: October 4, 2021
Phase: N/A
Study type: Interventional

This is a Hybrid Type I Effectiveness-Implementation design. Specifically, this study proposes to test the effectiveness of STEP in reducing suicidal events and ideation in 216 adolescents, admitted to inpatient psychiatric care due to suicide risk. Participants will be randomized to either STEP or ETAU. STEP involves 4 in-person sessions (3 individual, 1 family) focused on psychoeducation regarding positive and negative affect, mindfulness meditation, gratitude, and savoring. Mood monitoring prompts and skill reminders will be sent daily for the first month post-discharge and three times a week for the following two months. The ETAU condition will receive reminders to log into a safety resource app, matched in frequency to the STEP group. Effectiveness aspects of the design include using clinical staff as interventionists and having very few exclusion criteria.

NCT ID: NCT04962373 Recruiting - Suicide, Attempted Clinical Trials

Brief Admission for Adolescents Who Self-harm

Start date: September 1, 2020
Phase:
Study type: Observational

There is still no consensus on how to manage suicidal behavior in youth with recurrent self-harm at times when the risk for suicide is imminent (1). Brief Admission (BA) has evolved as a promising crisis intervention for adults with self-harm (2). The characteristics of BA is different from other types of admission, being focused on prevention through increased autonomy and self-care, based on structured and voluntary brief self-referrals to hospital (3). As a result of a randomized controlled trial, BA is since January 2019, continuously offered to adults with self-harm at risk for suicide in Skåne (4). Parallel to this clinical trial, the method has been adapted to work in a psychiatric setting for adolescents. At present 24 adolescents have access to the method in Skåne. Clinical experiences from staff are promising, however, the lived experiences have not been collected in a standardized way. The aim of the present study is to gather information on how BA in its present, standardized form works for adolescents, their loved ones and staff working at the ward providing BA. This will be done through semi-structured interviews with: 1. Adolescents using BA and their loved ones 2. Staff working at the ward providing BA. Data will be analyzed with qualitative analysis (5, 6). The ultimate aim is to use these results to optimize the current standardized version of BA for adolescents in order to test in a randomized clinical trial.

NCT ID: NCT04770168 Recruiting - Suicidal Ideation Clinical Trials

Harry Potter as a Novel Educational Paradigm to Improve Mental Wellness in Children: A Prospective Trial

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

School-based mental health literacy interventions have been shown to reduce and/or prevent suicidal ideation and attempts. Most programs to date include an adapted version of Cognitive Behavioural Therapy (CBT) - the gold standard treatment for youth and adult mood and anxiety disorders. CBT teaches youth about the relationship between their thoughts, feelings, and behaviours, and provides strategies for managing distress. However, there is no established standard mental health literacy curriculum in Ontario. The investigators developed a school-based mental health literacy program that uses the third book in the Harry Potter series ('Harry Potter and the Prisoner of Azkaban') to teach students how to cope with distress through CBT skills. This study will determine whether the Harry Potter-based mental health literacy curriculum diminishes suicidality in students. The study will also determine whether the curriculum decreases depression and anxiety symptoms and improves well-being. The 3-month intervention is a manual-based curriculum which teaches CBT skills in English class. The website includes video and text-based onboarding to train teachers on all the lessons. Youth complete online exercises for each unit and teachers follow a manual with checklists to preserve high fidelity and standardization of core learning. Participating classes will be randomized in 1:1 fashion to receive the curriculum in the fall (~Oct-Dec) or the winter (~Feb-Apr). The study will use a stepped-wedge design to introduce the curriculum to classes sequentially testing whether students who receive it in fall will improve at mid-year and those in winter will catch up by year-end. The winter group is included as a "maturational" control to account for changes over the school year that are independent of the intervention and so that order effects of curriculum delivery can be tested. For this design, questionnaires will be administered four times throughout the school year (once before and after each semester), and once more the following year to measure duration of response. At each timepoint, subjects will complete validated questionnaires about suicide attempts and self-harm, anxiety, depression, well-being, and health services usage. Students may also choose to participate in focus groups to collect qualitative data on their experience with the curriculum. With additional consent (Ontario youth only), we will also collect aggregate lists of the Ontario Health Insurance Plan (OHIP) numbers for participating students. These will be provided to the Institute of Clinical Evaluative Sciences (ICES) who will identify sex, age and pre-existing healthcare utilization matched controls from regions that do not adopt the curriculum.

NCT ID: NCT04763343 Recruiting - Suicide, Attempted Clinical Trials

Ketamine Treatment of Youth Suicide Attempters

Start date: June 27, 2022
Phase: Phase 3
Study type: Interventional

Ketamine, an NMDA antagonist, has been shown to have rapid anti- suicidal effects. However, its safety and efficacy and special populations has not been investigated and documented. Several reports in adults suggest rapid decrease of suicidal ideation. In the last decade there is an alarming increase of the number of suicide attempts in patients ages 14-30. Suicide is the second leading cause of death in this population. Patients with previous history of suicide attempt, are even in a higher risk category. The present study focus in this high risk group of suicide attempters. This will be a randomized controlled trial enrolling 140 youth between the ages 14-30 after a suicide attempt; patients will be randomized to receive Ketamine 0.5 mg/kg over 40 minutes or normal saline. Patients will receive all Ketamine or placebo infusions while admitted in the Inpatient Psychiatry Service. Patients will receive up to 6 ketamine or placebo infusions until, for 3 consecutive sessions, they have a clinician rated Scale for Suicidal Ideation (SSI) score of<4, and >50% decrease from baseline, and clinical assessment of patient not being suicidal, or they have been discharged from the inpatient unit. Patients will participate in weekly sessions of Collaborative Assessment for the management of Suicidality (CAMS), from the first week of the study while admitted to the hospital and will continue it on a weekly basis post-discharge until the patient has three consecutive outpatient CAMS sessions with an overall risk < 2 (# 6 on the SSF Core Assessment) along with a positive response regarding their thoughts/feelings and clinician indicating behavioral stability (suicidal behavior).

NCT ID: NCT04746261 Recruiting - Suicide, Attempted Clinical Trials

A Randomized Clinical Study of "Attempted Suicide Short Intervention Program" in Swedish Healthcare - ASSIP

Start date: October 15, 2020
Phase: N/A
Study type: Interventional

This is a randomized study of ASSIP as a treatment for patients who have recently made a suicide attempt. Six psychiatric clinics from four regions in Sweden are included. Together 460 patients will be recruited. Patients will be randomized to ASSIP as a supplement to treatment as usual or to treatment as usual only. The overall aim of the study is to evaluate whether ASSIP, a short-term clinical intervention, can prevent future suicidal behavior in people who have attempted suicide better than just conventional treatment. The project also investigates whether there are any specific factors that may be related to ASSIP's potential effectiveness and whether ASSIP has health economic benefits. Only patients who give their written consent will be included in the study. Those who meet the inclusion and no exclusion criteria at screening / visit 1 undergo an assessment according to an interview protocol, self-assessment form, and self-assessment scales. Thereafter, the patient is randomized via an electronic system to either ASSIP plus standard treatment or only standard treatment. All patients, regardless of which treatment they are randomized to, will be followed up for two years with a telephone interview and self-assessment scales month 3, 12 and 24. Data from medical records and registers will also be collected.

NCT ID: NCT04638205 Recruiting - Suicide, Attempted Clinical Trials

The Life Paths That Lead Teenagers to Attempted Suicide:Trajectories of Proximal Adversity

TAPAS
Start date: November 1, 2019
Phase:
Study type: Observational

Suicidal behaviors seriously alter the vital and functional prognosis of adolescents. Although the literature has lighted out a considerable number of risk factors for suicide attempts in youth, theoretical models - among which bio-psycho-social models - still lack empirical evidence. More specifically, the way adverse life events dynamically interact together and with the individual's diathesis to precipitate suicidal attempts remains unclear. Studies of life trajectories have opened an alternative approach to traditional linear epidemiological analysis to capture such a complex process. To date, adverse trajectories approaches never have been applied to the period immediately preceding the occurrence of the suicidal gesture (proximal adverse trajectories).

NCT ID: NCT04592809 Recruiting - Suicide, Attempted Clinical Trials

Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents

Start date: October 3, 2022
Phase: Phase 3
Study type: Interventional

This project aims to examine the efficacy of ketamine, a rapidly acting medication shown to decrease suicidality in adults in as short as hours or days, as opposed to weeks. The study design is a double-blind, randomized, active-control trial of adolescents (ages 13-18 years) with recent suicidal behaviors (suicide attempt or increased suicidal ideation). All participants must be receiving standard of care treatment which may range broadly from both outpatient and inpatient programs which include clinically indicated psychosocial and/or psychopharmacological treatments. Ketamine/midazolam treatment will occur twice weekly during the first two weeks of the study, followed by weekly assessments through week 12.

NCT ID: NCT04585802 Recruiting - Suicidal Ideation Clinical Trials

Expansion and Reevaluation of the Implicit Association Test in Suicide Ideators and Suicide Attempters

IAT-S
Start date: May 27, 2020
Phase:
Study type: Observational

A new approach to investigate suicidal processes belongs to the broader neurocognitive picture and are so-called implicit associations. In dual process models of information processing a second functioning mode, the automatic processing mode, complements the conscious processing. Suicidal persons tend to have a stronger implicit association with "death" than non-suicidal persons. In this study, implicit associations between different unconscious cognitive constructs are compared among suicidal and non-suicidal patients. Therefore, an adapted version of the computer-based reaction time task (IAT-S) will be used. Four different versions of IATs are tested in this study. In the first version the implicit association between "self / others" and "death / life" is assessed (1). The second and third version measures the emotional evaluation of "death" (2) and "life" (3). In addition, in the fourth version the implicit association between death / life and internal / external locus of control is assessed (4). The implicit associations of these four IAT-S versions are compared between three groups: patients with suicidal behavior, patients with suicidal ideation, and a clinical group without previous suicide attempts and without suicidal ideation. The following hypotheses are made: in all four versions of the IAT-S, patients with previous suicidal behavior will have stronger implicit associations: between "self" and "death" as well as "death" and "internal locus of control" compared to all other groups. With a more "positive" evaluation of "death" and a more "negative" evaluation of "life" than all other participants.

NCT ID: NCT04572321 Recruiting - Depression Clinical Trials

Youth Depression and Suicide Research Network

YDSRN
Start date: August 26, 2020
Phase:
Study type: Observational [Patient Registry]

The objective of this study is to build the Texas Youth Depression and Suicide Research Network to support the development of a Network Participant Registry and characterization of systems and interventions to examine statewide population health outcomes. All 12-13 sites represented in the Texas Child Mental Health Care Consortium (https://www.utsystem.edu/pophealth/tcmhcc/) have been invited to participate in the Texas Youth Depression and Suicide Research Network as "Nodes." 12 Nodes have been selected for this project. Each Node has obtained support of senior institutional leadership including the department chair. Leadership from each Node provided input and edits in the study design process by committee, with a focus on the inclusion of the "end user" in design decisions. Nodes will work closely with the Network Hub leadership to recruit, monitor, and retain participants. This will require active engagement and sustained relationships with clinics within the academic medical center as well as clinics in the community (i.e., psychiatry, psychology, counselling).

NCT ID: NCT04498143 Recruiting - Clinical trials for Nonsuicidal Self Injury

Single-Session Intervention Targeting Self-Injurious Behavior in Adolescents

Project SAVE
Start date: August 18, 2020
Phase: N/A
Study type: Interventional

Participants (aged 13-16) will be randomized to: (1) an online, active control group program encouraging feelings disclosure (i.e. supportive therapy single session intervention [SSI]), or (2) an online program targeting nonsuicidal self-injury (NSSI; i.e. Project "SAVE"-Stop Adolescent Violence Everywhere-SSI). Investigators will test whether SAVE results in significantly greater: 1. Reductions in NSSI 3 months post-treatment [primary outcome] 2. Reductions in self-reported likelihood of future NSSI immediately post-treatment [secondary outcome] 3. Reduction in suicide ideation frequency 3 months post-treatment [secondary outcome]