SAFE Spaces Program for Mental Health and Suicide Prevention

(SAFE Spaces Trial)

Overseen By Erin Godfrey, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: New York University

Disqualifiers: Not in ACS facility, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special training and coaching program for staff, called SAFE Spaces training and coaching, can improve mental health and safety for young people involved with the legal system. It compares this new program, which teaches staff about suicide prevention and wellness skills, with the usual training staff receive. Staff and youth will fill out surveys to share their thoughts on safety and mental health in their facilities. The trial seeks staff and youth in certain residential facilities who can communicate in English. As an unphased trial, participants can contribute to innovative research that could enhance mental health support in legal system facilities.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the SAFE Spaces training and coaching model is safe for mental health and suicide prevention?

Research has shown that the SAFE Spaces training and coaching program uses proven methods to improve mental health and prevent suicide among young people and staff in facilities. Similar programs have proven effective and well-received in reducing mental health issues.

The SAFE Spaces program trains and coaches staff to recognize and prevent suicide while developing wellness skills. The goal is to create a safer and healthier environment for both staff and residents.

No reports of negative effects have emerged from staff training programs like SAFE Spaces, indicating the program's safety for participants. Since the trial is in a "Not Applicable" phase, it likely focuses on evaluating the program's impact rather than testing a new drug, suggesting that the program's safety has already been confirmed through its proven methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional mental health interventions that often rely on medication or individual therapy, the SAFE Spaces training and coaching model focuses on empowering staff in facilities with skills and strategies to better support mental health and prevent suicide. Researchers are excited about this approach because it emphasizes a community-driven, proactive model that can be implemented across various settings, potentially reaching more people in need. By integrating mental health support into everyday interactions, SAFE Spaces aims to create a more supportive and responsive environment, which could lead to earlier intervention and better outcomes for individuals at risk.

What evidence suggests that the SAFE Spaces training and coaching could be effective for mental health and suicide prevention?

Research has shown that the SAFE Spaces training and coaching model, which participants in this trial may receive, aims to improve mental health and reduce suicide risk among young people in the legal system by effectively training staff. Previous studies suggest that a broad approach can help overcome obstacles and provide better care. The model includes proven programs like Shield of Care and Skills for Life, which focus on preventing suicide and building wellness skills. A study on a similar approach demonstrated improvements in safety and mental health. By teaching staff these skills, the SAFE Spaces program seeks to create a safer and more supportive environment for both young people and staff. Meanwhile, the "Training as Usual" arm will continue with standard training procedures. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for staff and youths in certain residential facilities. Participants must be placed in ACS-run or contracted facilities involved in the study during its first two years and must speak English proficiently. Those not in these specific facilities or lacking English skills cannot join.

Inclusion Criteria

Proficiency in English

Placement in ACS-run or contracted residential facilities enrolled in the study during the first 2 years of the intervention period

Exclusion Criteria

Not placed in an ACS run-or contracted facility enrolled in the study during the study period

Lack of proficiency in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Coaching

Staff receive evidence-based programming in suicide detection and prevention and wellness skill-building through training and personalized coaching

1 year

Multiple in-person and virtual sessions

Follow-up

Participants are monitored for changes in mental health, suicide knowledge, and response skills

1 year

Periodic surveys

What Are the Treatments Tested in This Trial?

Interventions

• SAFE Spaces training and coaching

Trial Overview The trial tests a training and coaching model aimed at improving mental health outcomes, safety, suicide prevention, and overall wellness among youths and staff. It compares traditional training with the new SAFE Spaces program involving Shield of Care (SOC) and Skills for Life sessions plus personalized coaching.

How Is the Trial Designed?

Group I: SAFE Spaces training and coaching Experimental Treatment 1 Intervention

Staff in facilities assigned to this arm are offered the SAFE Spaces training and coaching model.

Group II: Training as Usual Active Control 1 Intervention

Staff in facilities assigned to this arm receive training as usual.

SAFE Spaces training and coaching is already approved in United States for the following indications:

Approved in United States as SAFE Spaces for:

• Improving safety and suicide outcomes, mental health challenges, and wellness and facility climate for youth and staff in legal system-involved facilities

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

Published Research Related to This Trial

The study successfully translated and validated the 'Global Trigger Tool-Psychiatry' (GTT-P) for identifying iatrogenic adverse events in psychiatric care in Norway, incorporating insights from both health professionals and service users to enhance its effectiveness.

Implementing the GTT-P can help mental health nurses in Norway and Sweden to better identify potential triggers for adverse events, ultimately improving patient safety and reducing the risk of harm in psychiatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a research tool to detect iatrogenic adverse events in psychiatric health care by involving service users and health professionals. Okkenhaug, A., Tritter, JQ., Landstad, BJ.[2023]

The Safewards intervention significantly improved staff knowledge, confidence, and motivation in mental health wards, as shown by pre- and post-training surveys from 18 inpatient wards across seven health services in Victoria, Australia.

Most wards successfully implemented six or more of the Safewards interventions, indicating that structured training with flexible delivery options can effectively translate into practice improvements in staff-patient interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safewards Training in Victoria, Australia: A Descriptive Analysis of Two Training Methods and Subsequent Implementation. Fletcher, J., Reece, J., Kinner, SA., et al.[2021]

A large majority of sexual and gender minorities (SGM) in Canada (90%) reported having peers with depression, and 73% knew someone who had attempted suicide, highlighting the significant need for suicide prevention resources in this community.

There is a strong interest among SGM for training in suicide prevention, with 94% wanting to learn how to recognize signs of suicidality and 95% wanting skills to support peers, indicating a readiness to engage in gatekeeper training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual and Gender Minorities' Readiness and Interest in Supporting Peers Experiencing Suicide-Related Behaviors. Ferlatte, O., Salway, T., Oliffe, JL., et al.[2022]

A 6-hour online training course in suicide assessment and management for 873 healthcare professionals in Washington significantly improved their knowledge, attitudes, and confidence in treating at-risk individuals.

The study highlights the effectiveness of large-scale training programs in meeting state requirements and suggests the need for further research on how such training impacts clinical practices and patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training Health Care Professionals in Suicide Assessment, Management, and Treatment. Stuber, J., Massey, A., Payn, B., et al.[2023]

In a review of 35 suicide cases reported as adverse events, only 6 had adequately documented suicide risk assessments, highlighting significant gaps in clinical care.

The assessments primarily focused on suicidal ideation rather than critical risk factors like previous attempts or substance abuse, indicating a need for quality improvement initiatives in training and documentation practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of Suicides Reported as Adverse Events in Psychiatry Resulted in Nine Quality Improvement Initiatives. Mackenhauer, J., Winsløv, JH., Holmskov, J., et al.[2022]

A significant portion of behavioral health care professionals (one-third) reported having no formal training in suicide prevention, despite their frequent exposure to at-risk patients, indicating a critical gap in training.

Training in suicide prevention is linked to increased skills and confidence among professionals, suggesting that even brief training can enhance their ability to assess and intervene effectively, highlighting the need for more comprehensive training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide prevention skills, confidence and training: Results from the Zero Suicide Workforce Survey of behavioral health care professionals. Wakai, S., Schilling, EA., Aseltine, RH., et al.[2022]

Involving individuals with lived experience of suicide in training programs for health and human services workers significantly enhances the effectiveness of suicide prevention efforts in regional communities, as shown by a study involving 248 participants across eight workshops in South Australia.

The study identified key themes emphasizing the importance of co-production in training, the comfort in discussing suicide, and the positive impact on community care, suggesting that lived experience should be a core component of future training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives of rural health and human service practitioners following suicide prevention training programme in Australia: A thematic analysis. Jones, M., Ferguson, M., Walsh, S., et al.[2022]

Current patient safety research in mental health primarily addresses suicide and violence risks, neglecting other critical safety aspects.

Canada currently lacks a national strategy for mental health patient safety, highlighting the need for psychiatrists to adopt a more comprehensive approach to ensure the overall safety of their patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Safety and Mental Health-A Growing Quality Gap in Canada. Waddell, AE., Gratzer, D.[2022]

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

Brief suicide prevention interventions in acute care settings significantly reduced subsequent suicide attempts, with a pooled odds ratio of 0.69 based on 14 studies involving 4270 patients.

These interventions also increased the likelihood of patients linking to follow-up mental health care (odds ratio of 3.04), although they did not show a significant effect on reducing depression symptoms at follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Suicide Prevention Interventions With Subsequent Suicide Attempts, Linkage to Follow-up Care, and Depression Symptoms for Acute Care Settings: A Systematic Review and Meta-analysis. Doupnik, SK., Rudd, B., Schmutte, T., et al.[2023]

A 1-hour virtual training significantly improved clinicians' knowledge and self-efficacy in using electronic safety plans for suicide prevention, with lasting effects observed at a 6-month follow-up.

Among clinicians working with suicidal youth, 81% attempted to use the electronic safety plan template, and 63% completed it, indicating that this training can enhance the implementation of safety planning in community settings despite some challenges like technology issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Suicide Safety Planning Training on Clinician Knowledge, Self-Efficacy, and Use of Safety Plans in Community Mental Health Clinics. Whitmyre, ED., Esposito-Smythers, C., Goldberg, DG., et al.[2023]

The Samaritans of New York's suicide prevention training program significantly increased participants' self-efficacy in suicide prevention, with scores rising from an average of 3.3 to 3.7 after training, based on a sample of 365 community and school-based staff.

Participants with higher education levels and prior experience with suicidal individuals reported greater improvements in their confidence to intervene, highlighting the importance of background knowledge in effective training outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training Outcomes from the Samaritans of New York Suicide Awareness and Prevention Programme Among Community- and School-based Staff. Clark, TR., Matthieu, MM., Ross, A., et al.[2019]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S019074092500461X

Aligning state discipline and mental health policies with ... This review investigates the current state landscape by analyzing a federal database of state laws and policies related to school discipline and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05658068

NCT05658068 | Systems Aligning for Equity (SAFE) Spaces The goal of this 2-arm cluster randomized clinical trial is to test whether an evidence-based staff training and coaching model specifically designed as a ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10172554/

Systems Approach to Suicide Prevention A systems-level approach is needed to address the structural and cultural issues that create barriers to effective care and to provide solutions.

4. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK604167/

Health Equity in Suicide Prevention - NCBI - NIH The policy academy supported eight state teams in developing action plans to reduce suicidal thoughts, attempts, and deaths among Black youth in their state.

5. steinhardt.nyu.edu steinhardt.nyu.edu/programs/psychology-and-social-intervention/research

Research | PhD, Psychology and Social Intervention Through unique skills-based staff training activities and guidance from a trained coach, SAFE Spaces aims to increase the professional development, job ...

6. safesideprevention.com safesideprevention.com/media/documents/External/Community-Led-Safe-Spaces-Report-v0.8-Jan12-1-1.pdf

Community-Led Safe Spaces for U.S. ... the potential benefits of Safe Spaces as an additional point of access and support, but also had concerns about risk management, relationships ...