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

Trial Summary

What is the purpose of this trial?

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 response to legal system-involved youths' and frontline staff's mental health needs can improve the safety and suicide outcomes, mental health challenges, and wellness and facility climate for youth and staff in facilities assigned to the intervention condition. Staff in facilities assigned to the intervention are eligible to receive evidence-based programming in suicide detection and prevention (Shield of Care; SOC) and wellness skill-building (Skills for Life) through training and personalized coaching. Multiple training sessions will be offered to small groups of staff in-person in residential facilities and paired with personalized in-person and virtual coaching. Staff and youth in all facilities will be asked to complete periodic surveys assessing experiences in the facility, suicide and safety knowledge and risk, and their mental health and wellness. Researchers will compare outcomes of staff in youth in facilities assigned to the intervention compared to facilities in the training-as-usual condition.

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 data supports the effectiveness of the SAFE Spaces Program for Mental Health and Suicide Prevention treatment?

Research shows that training health care professionals in suicide prevention, like the SAFE Spaces Program, can improve their knowledge, confidence, and skills in managing at-risk individuals, which is crucial for effective suicide prevention. ^{1 2 3 4 5}

Is the SAFE Spaces Program for Mental Health and Suicide Prevention generally safe for humans?

There is no specific safety data available for the SAFE Spaces Program or its related names, but general safety concerns in mental health interventions often focus on the need for clear definitions and reporting of adverse events, especially in suicide prevention trials. ^{3 6 7 8 9}

How is the SAFE Spaces treatment different from other suicide prevention treatments?

The SAFE Spaces treatment is unique because it focuses on training and coaching to align systems for equity, involving community and school-based staff, and emphasizes the involvement of people with lived experience in its development and delivery, which is not commonly seen in other suicide prevention programs. ^{1 3 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Suicide prevention skills, confidence and training: Results from the Zero Suicide Workforce Survey of behavioral health care professionals. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Safewards Training in Victoria, Australia: A Descriptive Analysis of Two Training Methods and Subsequent Implementation. [2021]

3. England 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Training Health Care Professionals in Suicide Assessment, Management, and Treatment. [2023]

5. United States 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. [2023]

6. England 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. [2022]

7. England 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Patient Safety and Mental Health-A Growing Quality Gap in Canada. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Analysis of Suicides Reported as Adverse Events in Psychiatry Resulted in Nine Quality Improvement Initiatives. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Training Outcomes from the Samaritans of New York Suicide Awareness and Prevention Programme Among Community- and School-based Staff. [2019]

11. Canada pubmed.ncbi.nlm.nih.gov

Sexual and Gender Minorities' Readiness and Interest in Supporting Peers Experiencing Suicide-Related Behaviors. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Perspectives of rural health and human service practitioners following suicide prevention training programme in Australia: A thematic analysis. [2022]