Suicide Prevention Interventions for Suicidal Thoughts in Young Adults

Recruiting at 2 trial locations

Overseen By Elizabeth Arnold, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Elizabeth Arnold

Disqualifiers: Developmental disability, Psychosis, Mania, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 months

1485 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to reduce suicide among young people by testing two short online programs. These programs are designed to help reduce suicidal thoughts and will be delivered through primary care clinics in Texas.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but it does allow participants who have been on medication in the past 90 days.

What data supports the effectiveness of the treatment STAT-PC, YST-III for preventing suicidal thoughts in young adults?

Research shows that similar treatments, like cognitive-behavioral therapy (CBT) and motivational interviewing-enhanced safety planning, have been effective in reducing suicidal thoughts and improving coping skills in young people. These therapies help individuals manage their feelings and improve their problem-solving abilities, which can be beneficial for preventing suicide. ^{1 2 3 4 5}

Is the treatment safe for humans?

The pilot study on ketamine infusion suggests it may be a safe method to rapidly reduce suicidal symptoms in high-risk patients, with benefits lasting up to 6 months. ^{6 7 8 9 10}

How is the treatment STAT-PC, YST-III different from other treatments for suicidal thoughts in young adults?

The treatment STAT-PC, YST-III is unique because it combines social support and health behavior models, involving youth-nominated adults who provide tailored psychoeducation and regular supportive contact, which supplements standard treatments. This approach is different from traditional therapies like cognitive-behavioral therapy (CBT) that focus more on individual psychological strategies. ^{1 11 12 13 14}

Research Team

Elizabeth Arnold, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for sexual and gender diverse young adults aged 18-24 in Texas who speak English, have not had mental health services (except medication/case management) in the past 90 days, and are at risk of suicide.

Inclusion Criteria

I haven't seen a mental health professional, except for medication or case management, in the last 3 months.

Screen positive for suicide risk

English-speaking

Exclusion Criteria

I cannot identify anyone to support me during the intervention.

Are actively suicidal

Have a developmental disability that would preclude them from participating in the study intervention

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of two brief suicide prevention interventions adapted for use in primary care via telehealth

12 months

Telehealth sessions at baseline and months 1, 3, 6, 9, and 12

Follow-up

Participants are monitored for changes in suicidal ideation, mental health service utilization, and other secondary outcomes

12 months

Assessments at baseline and months 1, 3, 6, 9, and 12

Treatment Details

Interventions

• STAT-PC
• YST-III

Trial Overview The study aims to reduce suicide by comparing two telehealth interventions adapted for sexual and gender diverse youth: YST-III vs. STAT-PC. Clinics will be randomly chosen to use one of these methods with participants.

Participant Groups

Group I: Youth-Nominated Support Team (YST-III) Experimental Treatment 1 Intervention

This group will participate in a brief, suicide prevention intervention originally developed for youth who have been psychiatrically hospitalized due to a suicide attempt or suicidal ideation that has been adapted.

Group II: Suicidal Teens Accessing Treatment - Primary Care (STAT-PC) Experimental Treatment 1 Intervention

This group will participate in a brief, suicide prevention intervention based on motivational interviewing that focuses on mental health care seeking behavior, problem-solving, and referrals plus brief case management that has been adapted.

STAT-PC is already approved in United States for the following indications:

Approved in United States as STAT-PC for:

• Suicide prevention among sexual and gender diverse youth

Who Is Running the Clinical Trial?

Elizabeth Arnold

Lead Sponsor

Trials

2

Recruited

1,600+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Findings from Research

Cognitive-Behavioral Therapy (CBT) significantly reduced suicidal ideation and hopelessness in depressed adolescents aged 12 to 18 who had attempted suicide, with a 54% to 77% decrease in scores after 12 weeks of treatment.

In a clinical trial involving 30 participants, those receiving CBT showed marked improvements compared to a control group that did not receive the intervention, highlighting the efficacy of CBT in this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive-behavioral therapy in decreasing suicidal ideation and hopelessness of the adolescents with previous suicidal attempts. Alavi, A., Sharifi, B., Ghanizadeh, A., et al.[2022]

A time-limited outpatient intervention for suicidal young adults was found to be effective, with 264 participants showing significant improvements in suicidal ideation, behavior, and associated symptoms over a 24-month follow-up period.

The experimental treatment was particularly effective in retaining high-risk participants compared to standard treatment, highlighting its potential as a targeted approach for this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an outpatient intervention targeting suicidal young adults: preliminary results. Rudd, MD., Rajab, MH., Orman, DT., et al.[2022]

The MI-SafeCope intervention, which combines motivational interviewing with safety planning, was found to be feasible and acceptable for hospitalized teens at risk of suicide, with high participation and satisfaction rates among the 36 adolescents studied.

Preliminary results indicated that teens in the MI-SafeCope group showed significantly improved self-efficacy in managing suicidal thoughts and a greater likelihood of using safety plans, while parents also reported increased motivation to support these safety plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational Interviewing-Enhanced Safety Planning for Adolescents at High Suicide Risk: A Pilot Randomized Controlled Trial. Czyz, EK., King, CA., Biermann, BJ.[2020]

In a study of 665 outpatients with major depressive disorder, baseline suicidal ideation was linked to more severe depression and poorer quality of life, but did not affect overall treatment outcomes after 12 or 28 weeks.

Bupropion sustained release combined with escitalopram was the most effective treatment for reducing suicidal ideation, while the combination of venlafaxine extended release and mirtazapine was associated with a higher risk of suicide attempts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of antidepressant medication treatment on suicidal ideation and behavior in a randomized trial: an exploratory report from the Combining Medications to Enhance Depression Outcomes Study. Zisook, S., Lesser, IM., Lebowitz, B., et al.[2022]

In a study of 173 suicidal youth aged 12-18, those receiving dialectical behavior therapy (DBT) showed a significantly higher likelihood of improvement in self-harm (SH) compared to those receiving supportive therapy, with 63% improving in suicidal ideation (SI) and 74% in SH.

The study identified that 13% of participants were total nonresponders, with a notable increase in self-harm among these individuals during treatment, highlighting the need for personalized treatment approaches based on predictors of nonresponse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trajectories of Treatment Response and Nonresponse in Youth at High Risk for Suicide. Berk, MS., Gallop, R., Asarnow, JR., et al.[2023]

Designing randomized controlled trials (RCTs) for suicidal youths is complex due to the need for careful selection of hypotheses, sampling frames, interventions, and outcome measures to ensure feasibility and ethical standards.

The manuscript reviews existing studies and highlights the importance of using measurable and sensitive outcome variables to effectively assess treatment efficacy, while also discussing alternative methodologies to better address the unique needs of this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can randomized controlled trials be done with suicidal youths? Cwik, MF., Walkup, JT.[2008]

The study presents a consensus framework for assessing the risk of treatment-related suicidal ideation and behavior (SIB) during drug development, addressing a growing concern among health authorities.

This framework considers various factors, including the chemical and pharmacological properties of drugs, patient populations, and regulatory precedents, to better identify and manage SIB risks in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated risk assessment of suicidal ideation and behavior in drug development. Muller, PY., Dambach, D., Gemzik, B., et al.[2022]

In a study involving 16 recent suicide attempters, a single intravenous dose of ketamine (0.5 mg/kg) led to rapid and significant reductions in suicidal thoughts within 24 hours, with effects lasting up to 6 months post-infusion.

The results indicate that ketamine is a safe and effective treatment for reducing suicidality in high-risk patients, suggesting it could be integrated into existing healthcare settings for those in acute psychiatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Ketamine Infusion after Suicide Attempt: New Frontiers in Treating Acute Suicidality in a Real-World Medical Setting. Shivanekar, S., Gopalan, P., Pizon, A., et al.[2023]

A Scale for Suicide Ideation (SSI) score of 16 was identified as a critical cut-point to distinguish between stable out-patients and those in a suicidal emergency, demonstrating 100% sensitivity and 91% specificity in a study of 34 patients.

This finding suggests that using an SSI score of 16 could help safely exclude high-risk individuals from participating in clinical trials for depression, thereby enhancing patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A psychometric cut-point to separate emergently suicidal depressed patients from stable depressed outpatients. McCall, WV., Batson, N., Webster, M., et al.[2021]

There is a critical need for randomized controlled trials (RCTs) focused on pharmacologic treatments for individuals at elevated risk of suicide, as current studies are limited.

Existing trials of medications like lithium, clozapine, and ketamine provide valuable insights into trial design and patient selection, highlighting that RCTs for suicide prevention are both feasible and necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing Clinical Trials to Assess the Impact of Pharmacological Treatment for Suicidal Ideation/Behavior: Issues and Potential Solutions. Yao, Z., McCall, WV.[2023]

A systematic review of 28 trials involving various psychosocial interventions found that over half of the programs significantly reduced suicidal ideation, attempts, and self-harm in young people aged 12-25.

The review highlights the potential effectiveness of universal and targeted interventions, particularly in school settings, but emphasizes the need for further quality research to strengthen the evidence for these suicide prevention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of psychosocial suicide prevention interventions for youth. Calear, AL., Christensen, H., Freeman, A., et al.[2022]

The Youth-Nominated Support Team-Version II (YST-II) intervention showed limited positive effects for suicidal adolescents, particularly benefiting those with a history of multiple suicide attempts by reducing suicidal ideation more rapidly in the first 6 weeks after hospitalization.

While YST-II did not significantly impact overall suicide attempts or long-term suicidal ideation, it was associated with improved functional outcomes for nonmultiple attempters at 3 and 12 months, indicating some potential benefits in specific subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Youth-Nominated Support Team-Version II for suicidal adolescents: A randomized controlled intervention trial. King, CA., Klaus, N., Kramer, A., et al.[2022]

A systematic review of 15 randomized controlled trials found very limited evidence for effective interventions for adolescents and young adults experiencing suicidal thoughts or self-harm, highlighting the need for more rigorous studies.

Cognitive Behavioral Therapy (CBT) showed some promise in one study compared to usual treatment, suggesting it may be a potential intervention, but further research is necessary to confirm its effectiveness in reducing suicide risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing suicide in young people: systematic review. Robinson, J., Hetrick, SE., Martin, C.[2022]

This study will enroll 300 high-risk youth aged 12-24 to compare two suicide prevention interventions: Zero Suicide Quality Improvement (ZSQI) and ZSQI plus a stepped care intervention (SC-SP) that includes tailored services like dialectical behavior therapy.

The primary goal is to determine if the SC-SP intervention is more effective than ZSQI alone in reducing both fatal and nonfatal suicide attempts, with outcomes assessed at multiple time points over a year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepped care for suicide prevention in teens and young adults: Design and methods of a randomized controlled trial. Sheppler, CR., Edelmann, AC., Firemark, AJ., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive-behavioral therapy in decreasing suicidal ideation and hopelessness of the adolescents with previous suicidal attempts. [2022]

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

Effectiveness of an outpatient intervention targeting suicidal young adults: preliminary results. [2022]

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

Motivational Interviewing-Enhanced Safety Planning for Adolescents at High Suicide Risk: A Pilot Randomized Controlled Trial. [2020]

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

Effect of antidepressant medication treatment on suicidal ideation and behavior in a randomized trial: an exploratory report from the Combining Medications to Enhance Depression Outcomes Study. [2022]

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

Trajectories of Treatment Response and Nonresponse in Youth at High Risk for Suicide. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Can randomized controlled trials be done with suicidal youths? [2008]

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

Integrated risk assessment of suicidal ideation and behavior in drug development. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Pilot Study of Ketamine Infusion after Suicide Attempt: New Frontiers in Treating Acute Suicidality in a Real-World Medical Setting. [2023]

9. India pubmed.ncbi.nlm.nih.gov

A psychometric cut-point to separate emergently suicidal depressed patients from stable depressed outpatients. [2021]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Designing Clinical Trials to Assess the Impact of Pharmacological Treatment for Suicidal Ideation/Behavior: Issues and Potential Solutions. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

A systematic review of psychosocial suicide prevention interventions for youth. [2022]

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

The Youth-Nominated Support Team-Version II for suicidal adolescents: A randomized controlled intervention trial. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Preventing suicide in young people: systematic review. [2022]

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

Stepped care for suicide prevention in teens and young adults: Design and methods of a randomized controlled trial. [2023]