Safety Planning + Give to Others Module for Suicidal Thoughts

Overseen By Jeremy Pettit, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Florida International University

Disqualifiers: Cognitive impairment, Developmental delay, others

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

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This project is designed to test a brief therapy to reduce suicidal ideation among a diverse sample of youths ages 12 to 17 who experience anxiety or depression. The goal of the study is to conduct a clinical trial testing whether this therapy reduces suicidal ideation and related beliefs that one is a burden on others. This project will contribute to the field by potentially showing evidence supportive of a brief strategy to reduce suicidal ideation in a way that can be readily understood and used by mental health providers in the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently involved in a psychosocial treatment, you may be excluded from participating.

What data supports the effectiveness of the treatment Give to Others Module for suicidal thoughts?

Research on safety planning interventions, which are similar to the Give to Others Module, shows they can effectively reduce suicidal behavior by helping individuals identify coping strategies and engage supportive relationships. These interventions have been found to decrease suicidal ideation and behavior, as well as reduce depression and hopelessness. ^{1 2 3 4 5}

Is the Safety Planning + Give to Others Module safe for humans?

The Safety Planning Intervention (SPI) is generally considered safe and is used to help people with suicidal thoughts. It has been shown to be feasible and acceptable in various settings, including for veterans, and can be adapted to different formats like face-to-face or online. ^{1 3 4 6 7}

How does the Give to Others Module treatment for suicidal thoughts differ from other treatments?

The Give to Others Module is unique because it combines safety planning with a focus on enhancing social connections and altruistic behavior, which is not a standard approach in existing treatments for suicidal thoughts. This treatment emphasizes the importance of social relationships and giving to others as a way to cope with suicidal urges, which is a novel aspect compared to traditional interventions. ^{2 3 4 6 8}

Research Team

Victor Buitron, PhD

Principal Investigator

Florida International University

Eligibility Criteria

This trial is for youths aged 12 to 17 who are experiencing anxiety or depression, have thoughts of being a burden on others, and show signs of suicidal ideation. It's not specified who can't join the trial.

Inclusion Criteria

Adolescents must have a positive screen for suicide risk (i.e., endorsement of suicidal ideation via self-report or parent-report)

I am between 12 and 17 years old.

I scored 4 or higher on a test measuring feelings of being a burden.

Exclusion Criteria

I have a cognitive impairment or developmental delay that prevents me from completing basic tasks like filling out forms or speaking with a doctor.

I am currently receiving counseling or therapy.

Adolescents must show imminent risk or a history of hurting themselves or others requiring intensive and restrictive services

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a brief therapy module to reduce suicidal ideation, including the 'Give to Others' module or a safety planning protocol

4 weeks

Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for changes in perceived burdensomeness and suicidal ideation post-treatment

1 week

1 visit (in-person or virtual)

Treatment Details

Interventions

• Give to Others Module

Trial Overview The study tests a brief therapy aimed at reducing suicidal thoughts by addressing feelings of burdensomeness. Youths will participate in Safety Planning and Give to Others Module interventions.

Participant Groups

Group I: Safety Planning and "Give to Others" Module Experimental Treatment 2 Interventions

A standard suicide risk assessment and management protocol followed by the "Give to Others" Module which is a brief cognitive behavioral intervention.

Group II: Safety Planning Active Control 1 Intervention

A standard suicide risk assessment and management protocol.

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

Findings from Research

The LINC to LIFE Safety Planning (L2L SP) training program, which lasts 150 minutes, significantly improved mental health providers' knowledge, perceived behavioral control (PBC), and intentions regarding safety planning for suicidal clients immediately after the training.

At a six-month follow-up, improvements in attitudes, PBC, and emotional responses were noted, suggesting that the training has lasting benefits, although declines in knowledge indicate a need for refresher sessions to maintain effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LINC to Life: Evaluation of a Safety Planning Training Program with Clinicians and Mental Health Staff. Bender, AM., Schuck, A., Peterson, AL., et al.[2022]

The Safety Planning Intervention (SPI) is a structured six-step action plan designed to help individuals at risk of suicide by enhancing their coping strategies and social support, and by removing access to means of self-harm.

Research shows that SPI is highly effective in reducing suicidal behavior, making it a valuable tool in various settings such as emergency rooms and outpatient clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[SAFETY PLANNING INTERVENTION FOR SUICIDE PREVENTION]. Perlstein, J., Katzir, N., Lotan, A., et al.[2022]

The Safety Planning Intervention (SPI) is effective in reducing suicidal ideation and behavior, as well as improving depression and treatment engagement among adults experiencing suicide-related distress, based on a systematic review of 26 studies.

The SPI is adaptable and can be delivered in various formats (in-person or online) and as a standalone or combined intervention, making it a flexible tool in suicide prevention practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. Ferguson, M., Rhodes, K., Loughhead, M., et al.[2022]

The suicide safety plan is a collaborative tool between clinicians and patients that outlines steps to take when experiencing suicidal urges, emphasizing its importance in clinical practice despite not being a treatment itself.

While the safety plan is beneficial for managing suicidal thoughts, there is a critical need for further research to develop effective treatments and prevention strategies for suicidality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching health care professionals about suicide safety planning. Sher, L., LaBode, V.[2022]

A meta-analysis of 6 studies involving 3536 participants found that safety planning-type interventions (SPTIs) significantly reduce suicidal behavior, with a relative risk of 0.570 compared to control groups, indicating they are effective in preventing suicide attempts.

However, the same analysis showed no significant effect of SPTIs on reducing suicidal ideation, suggesting that while SPTIs are beneficial for preventing actions, additional strategies may be necessary to address thoughts of suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety planning-type interventions for suicide prevention: meta-analysis. Nuij, C., van Ballegooijen, W., de Beurs, D., et al.[2022]

Safety planning, including lethal means safety (LMS) counseling, is crucial for reducing suicide and violence risk by helping at-risk patients make safer firearm storage decisions.

The article provides a framework and evidence for effectively delivering LMS counseling, emphasizing the importance of individualized safety recommendations and proper documentation of these discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Risk Management and Firearm-related Lethal Means Safety. Simonetti, JA., Wortzel, HS., Matarazzo, BB.[2023]

Higher quality Safety Plans (SPs) for veterans, which are more personally relevant, are associated with a decreased likelihood of future suicide-related behaviors, based on a study of 68 veterans over several years.

Specifically, the component of the SP that identifies people and places for distraction was particularly effective in reducing reports of self-harm and suicide attempts, indicating that personalized elements in SPs may enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of Safety Plans for Military Veterans: Do Safety Plans Tailored to Veteran Characteristics Decrease Suicide Risk? Green, JD., Kearns, JC., Rosen, RC., et al.[2019]

In a study of 1,602 veterans, 30% of safety plans for suicide prevention were missing social contacts for distraction or help, which is crucial during a crisis.

Notably, veterans without a help contact were over twice as likely to attempt suicide or die by suicide in the following year, highlighting the importance of including social support in safety plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive Importance of Social Contacts on U.S. Veteran Suicide Safety Plans. Chalker, SA., Parrish, EM., Martinez Ceren, CS., et al.[2023]

References

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

LINC to Life: Evaluation of a Safety Planning Training Program with Clinicians and Mental Health Staff. [2022]

2. Israel pubmed.ncbi.nlm.nih.gov

[SAFETY PLANNING INTERVENTION FOR SUICIDE PREVENTION]. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. [2022]

4. Croatia pubmed.ncbi.nlm.nih.gov

Teaching health care professionals about suicide safety planning. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Safety planning-type interventions for suicide prevention: meta-analysis. [2022]

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

Therapeutic Risk Management and Firearm-related Lethal Means Safety. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of Safety Plans for Military Veterans: Do Safety Plans Tailored to Veteran Characteristics Decrease Suicide Risk? [2019]

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

Predictive Importance of Social Contacts on U.S. Veteran Suicide Safety Plans. [2023]