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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new therapy designed to reduce suicidal thoughts and feelings of being a burden among teens with anxiety or depression. The treatment includes standard safety planning and a "Give to Others" module, a brief cognitive behavioral intervention. Teens who frequently feel like a burden and have experienced suicidal thoughts might benefit from this trial. Participants should not have cognitive impairments that hinder their ability to complete study tasks or be currently receiving psychotherapy. As an unphased trial, this study provides a unique opportunity for teens to access innovative therapy that could significantly enhance their mental health.

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 prior data suggests that this therapy is safe for reducing suicidal ideation in youths?

Research has shown that the "Give to Others" module is a form of cognitive behavioral therapy (CBT), which is generally well-received. CBT focuses on changing negative thoughts and behaviors and has been safely used for various mental health issues.

The trial is in an early stage, so there might not be extensive data on its safety yet. However, therapies like this one are not known to have serious side effects. They mainly involve talking and thinking differently, which poses little physical risk.

No specific negative effects have been reported for the "Give to Others" module. So far, it appears safe for young people dealing with anxiety and depression. ¹

Why are researchers excited about this trial?

Researchers are excited about the "Give to Others" Module because it introduces a unique approach to addressing suicidal thoughts by focusing on positive social engagement. Unlike traditional treatments that often center around medication or individual therapy sessions, this module emphasizes helping others as a form of cognitive behavioral intervention. By encouraging individuals to engage in acts of giving, it may promote improved mental health through enhanced social connections and a sense of purpose. This approach could offer a fresh perspective and an additional tool for those dealing with suicidal ideation.

What evidence suggests that the "Give to Others" Module could be effective for reducing suicidal thoughts in youths?

Research has shown that programs like the "Give to Others" Module, which participants in this trial may receive, can help reduce suicidal thoughts. This module encourages acts of kindness, boosting feelings of connection and self-worth. Early results suggest that when individuals perceive their positive impact, they may feel less burdensome. By addressing these feelings, the module aims to reduce thoughts of suicide. This approach has shown promise in helping participants feel more valued and less isolated, important factors in reducing suicidal thoughts. ¹

Who Is on the Research Team?

Victor Buitron, PhD

Principal Investigator

Florida International University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/clinical-trials/near-el-segundo-ca?page=7

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