Intensive Crisis Intervention for Suicidal Thoughts

(ICI Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Jennifer Hughes

Disqualifiers: Intellectual disability, Actively psychotic, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4.5 days (ICI) or 9-11 days (APIU)

180 Participants Needed

Trial Summary

What is the purpose of this trial?

The study's purpose is to improve the clinical management of severe crises experienced by youth with psychiatric disorders by examining a brief, evidence-based alternative to inpatient psychiatric care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Intensive Crisis Intervention for suicidal thoughts?

The study on Intensive Crisis Intervention (ICI) for adolescents showed that this cognitive-behavioral, family-centered treatment is feasible and acceptable, providing an alternative to longer inpatient care for suicidal ideation and behavior. Additionally, the Collaborative Assessment and Management of Suicidality (CAMS), a similar structured intervention, demonstrated significant reductions in suicidal thoughts and related factors in both pilot and controlled-comparison trials, suggesting that structured, suicide-specific interventions can effectively reduce suicide risk. ^{1 2 3 4 5}

Is Intensive Crisis Intervention for Suicidal Thoughts safe for humans?

There is limited safety data specifically for Intensive Crisis Intervention, but studies highlight the importance of clear definitions and consistent reporting of adverse events (unwanted effects from treatment) in suicide prevention trials. Using multiple methods, like structured follow-up calls, can improve detection of these events, suggesting that safety monitoring is crucial in such interventions. ^{6 7 8 9 10}

How does Intensive Crisis Intervention differ from other treatments for suicidal thoughts?

Intensive Crisis Intervention is unique because it focuses on immediate, professional support during a suicidal crisis, emphasizing a collaborative relationship and thorough assessment to stabilize emotions and restore functioning. Unlike some other treatments, it may involve family intervention and support systems to address both acute and long-term risks. ^{11 12 13 14 15}

Research Team

Jennifer L Hughes

Principal Investigator

Nationwide Children's Hospital

Eligibility Criteria

This trial is for young individuals experiencing severe mental health crises, such as suicidal thoughts or attempts. Specific details on eligibility criteria are not provided, but typically participants would need to meet certain mental health assessments to qualify.

Inclusion Criteria

I am between 12 and 17 years old.

Be eligible for admission to both YCSU and APIU based on PCD clinician's clinical judgement

Legal guardian must attend the PCD evaluation

Exclusion Criteria

Inability to speak or read English adequately to understand and complete study consent and procedures

I understand the study procedures and am mentally capable of participating.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Testing

Pilot test implementation of Intensive Crisis Intervention (ICI) with adolescents, parents, and providers to refine the intervention.

1 year

Treatment

Participants receive Intensive Crisis Intervention (ICI) or traditional inpatient care. ICI involves 2-3 individual sessions and 1-2 family sessions daily.

4.5 days (ICI) or 9-11 days (APIU)

Follow-up

Participants are monitored for changes in family functioning, suicidal ideation, and other psychiatric symptoms at discharge, 30 days, and 3 months.

3 months

Treatment Details

Interventions

• Intensive Crisis Intervention

Trial Overview The study is testing a brief, evidence-based Intensive Crisis Intervention (ICI) against the standard care in an Adolescent Psychiatric Inpatient Unit (APIU). It aims to see if ICI can be an effective alternative for managing psychiatric emergencies in youth.

Participant Groups

Group I: Intensive Crisis Intervention (ICI) Active Control 1 Intervention

ICI is a brief (Average Length of Stay \[ALOS\]: M±SD=4.5±1.4 days), intensive family-centered, skills-based alternative to traditional inpatient psychiatric care. Adolescents participate in 2-3 individual sessions and 1-2 family sessions daily. Based on the cognitive-behavioral model of suicidality, ICI emphasizes that learned, maladaptive cognitive, behavioral, and affective responses to stressors contributing to suicidal behavior can be changed. Master's-level clinicians facilitate this process by engaging adolescents and their families in developing more effective coping skills when faced with potential triggers to suicidal crises.

Group II: Adolescent Psychiatric Inpatient Unit (APIU) Active Control 1 Intervention

APIU provides comprehensive assessment and treatment services to children and adolescents with significant psychiatric difficulties and to their families using a multidisciplinary approach. Symptoms and behaviors that led to admission are targeted through a milieu-based model of care and therapeutic group programming. The multidisciplinary treatment team includes a child and adolescent psychiatrist, often in collaboration with an advanced practice provider, psychologist, psychiatric nursing staff including trained mental health specialists, behavioral healthcare clinicians, care managers, rehabilitative care staff, teachers, and parent partners. Average length of stay is 9-11 days. An individualized treatment plan is developed by the entire treatment team, including the patient and caregivers, and includes initial planning for discharge with the primary treatment goal being stabilization of acute psychiatric symptoms. Programming is based on a trauma-informed biopsychosocial approach.

Who Is Running the Clinical Trial?

Jennifer Hughes

Lead Sponsor

Trials

2

Recruited

250+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Findings from Research

The pilot study demonstrated that The Collaborative Assessment and Management of Suicidality (CAMS) is feasible and effective for treating suicidal inpatients, with significant reductions in depression, hopelessness, and suicidal ideation over an average treatment period of 51 days.

With a sample of 20 patients, the intervention showed large treatment effect sizes (Cohen's d > .80), indicating strong potential for CAMS as a structured approach to reduce suicide risk in hospitalized individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative assessment and management of suicidality in an inpatient setting: results of a pilot study. Ellis, TE., Green, KL., Allen, JG., et al.[2021]

The case study of a 55-year-old housewife who committed suicide after psychiatric inpatient treatment highlights the complexities of managing patients with a history of severe suicide attempts, emphasizing the need for better understanding of their social and psychological contexts.

The therapy team concluded that insights from this tragic case could lead to improved management strategies for inpatient treatment following suicide attempts, suggesting that learning from unsuccessful interventions is crucial for enhancing future care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide following attempted suicide: a study of an unsuccessful intervention. Etzersdorfer, E.[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]

In a study involving 891 first-year college students, 18.7% were identified as at risk for self-harm or potentially lethal alcohol use, highlighting the prevalence of these issues in this population.

Outreach efforts successfully contacted 59.9% of at-risk participants, with 78% of those accepting mental health resources, demonstrating the effectiveness of proactive safety protocols in research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An example of implementing a safety protocol in remote intervention and survey research with college students. Mehus, CJ., Stevenson, B., Weiler, L., 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]

In the ED-SAFE study, structured telephone follow-up assessments were crucial for identifying adverse events (AEs), detecting 45% of total AEs that were missed by chart reviews alone.

The detection of suicide attempts varied significantly by method, with structured follow-ups identifying 59% of attempts compared to only 18% through chart reviews, highlighting the importance of using multiple detection methods in suicide research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using structured telephone follow-up assessments to improve suicide-related adverse event detection. Arias, SA., Zhang, Z., Hillerns, C., et al.[2021]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

The article reviews various ultra-brief and brief suicide-specific interventions, highlighting their potential to quickly stabilize individuals at risk of suicide, which is crucial given the rising suicide rates.

Several interventions, such as the Safety Planning Intervention and Cognitive Therapy for Suicide Prevention, have shown promising evidence for effectiveness, indicating a need for continued research to optimize these approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief and Ultra-Brief Suicide-Specific Interventions. Stanley, B., Brodsky, B., Monahan, M.[2023]

References

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

Collaborative assessment and management of suicidality in an inpatient setting: results of a pilot study. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

Suicide following attempted suicide: a study of an unsuccessful intervention. [2022]

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

Innovations in Practice: Intensive crisis intervention for adolescent suicidal ideation and behavior - an open trial. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Impact of a Suicide-Specific Intervention within Inpatient Psychiatric Care: The Collaborative Assessment and Management of Suicidality. [2022]

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

Effect of Crisis Response Planning on Patient Mood and Clinician Decision Making: A Clinical Trial With Suicidal U.S. Soldiers. [2022]

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

An example of implementing a safety protocol in remote intervention and survey research with college students. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Using structured telephone follow-up assessments to improve suicide-related adverse event detection. [2021]

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

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

11. France pubmed.ncbi.nlm.nih.gov

[Impact of the suicidal crisis intervention training program on the confidence and skills of hospital professionals in the Hauts-de-France region]. [2023]

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

Brief and Ultra-Brief Suicide-Specific Interventions. [2023]

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

The subacute hospital treatment of the borderline patient: III. Management of suicidal crisis by family intervention. [2022]

14. Croatia pubmed.ncbi.nlm.nih.gov

[Crisis intervention - Professional first aid in acute crisis]. [2020]

15. Switzerland pubmed.ncbi.nlm.nih.gov

[Crisis intervention in suicidal subjects]. [2022]