Intensive Crisis Intervention for Suicidal Thoughts

(ICI Trial)

Overseen By Anastasia Berg

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)

213 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for managing severe mental health crises in young people with psychiatric disorders. It focuses on Intensive Crisis Intervention, a structured support program, as an alternative to traditional inpatient care, aiming to provide effective support during critical times. The trial includes different groups: some will receive the intervention based on a plan, others will be treated according to the hospital's discretion, and some will be observed without receiving the intervention. It seeks participants aged 12 to 17 who have visited the hospital for suicidal thoughts or behaviors and are open to different treatment settings. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative mental health solutions.

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 prior data suggests that Intensive Crisis Intervention is safe for youth with psychiatric disorders?

Research shows that Intensive Crisis Intervention (ICI) is a promising method for helping young people with severe mental health issues. Studies have found that this approach can significantly reduce thoughts of suicide. For instance, one study discovered that after a three-day ICI, participants experienced fewer suicidal thoughts three months later.

While these results are promising, they primarily focus on the method's effectiveness rather than detailed safety information. The trial is labeled as "Not Applicable" for phase, indicating limited data on how participants handle it. However, since no serious side effects have been reported in these studies, it appears to be well-tolerated.

Prospective participants should discuss potential risks and benefits with the study team to understand what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Intensive Crisis Intervention for suicidal thoughts because it offers a more tailored and immediate response compared to traditional treatments like medication and long-term therapy. This approach focuses on transferring patients to specialized units, which can provide targeted care based on individual needs, either through a randomized or non-randomized process. By emphasizing crisis intervention and immediate support, this method has the potential to stabilize patients quickly, offering a crucial lifeline during acute episodes.

What evidence suggests that Intensive Crisis Intervention is effective for managing severe crises in youth with psychiatric disorders?

Research has shown that Intensive Crisis Intervention (ICI), which participants in this trial may receive, can greatly reduce suicidal thoughts. For example, one study found that areas using ICI experienced a 25% drop in suicide rates after the program was introduced. Another study demonstrated that ICI led to a significant decrease in suicidal thoughts three months later. Additionally, ICI has been proven to lower distress levels by an average of 43% during crisis calls. These findings suggest that ICI offers a promising alternative to long hospital stays for managing crisis situations. ^{1 3 6 7 8}

Who Is on the Research Team?

Jennifer L Hughes

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: As Treated Experimental Treatment 2 Interventions

Patient participant transferred to a non-randomized unit, either YCSU or APIU, due to clinical or hospital system factors.

Group II: Intervention Per Protocol Active Control 2 Interventions

Patient participant was transferred to either YCSU or APIU according to randomization

Group III: Observation Only Active Control 1 Intervention

Patient participant was discharged without receiving either intervention due to clinical factors

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+

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9092896/

Improving Suicide Prevention Through Evidenced-Based ... These findings indicate the benefit for suicide was found in the intervention counties and confined to the demographic group targeted by the intervention.

2. sciencedirect.com sciencedirect.com/science/article/pii/S016517812400088X

The effectiveness of a suicide prevention program in ... In other words, the suicide rate in the intervention area decreased by 25% following the intervention. These results empirically substantiate suicide prevention ...

3. nationwidechildrens.org nationwidechildrens.org/newsroom/news-releases/2019/12/ici-study

Study Shows Three-Day Intensive Crisis Intervention is ... ICI is a promising alternative to lengthy hospitalization. Findings also revealed significant reductions in suicidal ideation at the three-month follow-up.

4. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2019.00399/full

The Effectiveness of Crisis Line Services: A Systematic ... Monitors identified a mean 43% decreased caller distress from beginning to end of call (range 28–64%), with decreased distress associated with the crisis center ...

5. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-06109-z

A study protocol of the effectiveness of the Attempted Suicide ... Findings from this study will provide novel insights regarding the effects of ASSIP on not only subsequent suicidal behavior but also other ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10189833/

Effectiveness of Suicide Safety Planning Interventions Evidence across a range of studies indicates that SSP is effective for reducing suicide behavior (SB) and ideation (SI).

7. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2834286

Safety Planning Interventions for Suicide Prevention in ... This systematic review and meta-analysis investigates the effectiveness of safety planning as a standalone intervention for suicide ...

8. cdc.gov cdc.gov/suicide/pdf/preventionresource.pdf

Suicide Prevention Resource for Action Safety Planning Intervention were half as likely to exhibit suicidal behavior. 63. Page 64. 64. SUICIDE PREVENTION RESOURCE FOR ACTION. Cognitive Behavioral ...