Intensive Crisis Intervention

The objective of this study is to refine and test Intensive Crisis Intervention (ICI), a brief, evidence-based treatment that incorporates Family Therapy/Parent Training, Cognitive Behavioral Therapy and Motivational Interviewing to target family functioning in reducing adolescent suicidal behavior. The project's main goal is to examine feasibility, acceptability, research implementation procedures, and preliminary effectiveness of ICI using a mixed-methods approach. The investigators will utilize the extensive catchment area of Nationwide Children's Hospital Behavioral Health (NCH-BH) to complete this work. NCH-BH has a Youth Crisis Stabilization Unit (YCSU) in which ICI can be implemented and compared with outcomes from a traditional adolescent psychiatric inpatient unit (Adolescent Psychiatric Inpatient Unit \[APIU\]).

In Year 1, the investigators will further develop and refine an intervention implementation guide, including a formalized treatment manual, training and supervision protocols, and data collection processes. They will then pilot test implementation of ICI with 20 adolescents divided across the study age range of 12-17 years, 20 parents, and 16 providers. After refinement of ICI based on findings from the pilot, the investigators will recruit, assess and randomly assign 60 youth with suicidal ideation and/or behavior who are eligible for admission to both the YCSU and APIU to the YCSU (n=30) or APIU (n=30).

The central hypothesis is that ICI will be acceptable to families and show greater improvements in the investigators' proposed mechanism of change, family functioning, compared with results of traditional inpatient treatment, assessing outcomes at discharge, 30-day, and 3-month follow-up. The investigators have the following three specific aims:

Specific Aim 1: To develop, refine and pilot test ICI, including the ICI treatment manual, training, and supervision protocols, for youth with suicidal ideation and/or behavior, and to evaluate whether the proposed research implementation procedures are feasible and acceptable to adolescents, parents, and providers.

Specific Aim 2: To conduct a small randomized controlled trial to examine preliminary acceptability and effectiveness of the ICI intervention on the basis of primary outcomes (consumer satisfaction, family functioning) and secondary outcomes (suicidal ideation, suicide attempts, emergency department (ED)/inpatient admission, hopelessness, and therapeutic alliance).

Hypothesis 2a: ICI will result in higher consumer satisfaction compared to traditional inpatient treatment.

Hypothesis 2b: ICI will result in greater improvements in family functioning at discharge, 30-days, and 3-month follow-up compared to improvements made after traditional inpatient treatment.

Hypothesis 2c: ICI will result in lower rates of suicidal ideation, attempts, ED/inpatient admissions, lower hopelessness scores, and higher ratings of therapeutic alliance compared to traditional inpatient treatment.

Specific Aim 3: To identify barriers to and facilitators of implementation and sustainability of ICI using qualitative interviews and surveys with families, and clinical and organizational stakeholders.

During the RCT phase, there may be situations where the enrolled patient participant does not receive the randomized treatment due to clinical or hospital system factors. Example situations could include, but are not limited to:

1. There is a waitlist or longer wait time for the assigned unit. 2. A patient's clinical presentation changes and the treatment team's recommendations for care change. 3. Upon further observation or evaluation, a patient is determined to be able to engage in safety planning and can be discharged home.

Patient/parent participants will remain enrolled in the study and complete study measures and follow-up visits even if they do not receive their randomized treatment. Given the anticipated challenges with participants receiving the randomized condition we have planned the following analytic strategies:

1. Upon informed consent and baseline completion, participants will be randomized per protocol. Randomization outcome will be documented and conveyed to the clinical team. Study staff, via chart review, will monitor the participant's referral status and whether the participant is referred and successfully transferred to the randomized unit (i.e., APIU or YCSU). If a participant's referral status is changed for any reasons (e.g., due to waitlists or due to additional clinical information that changes the recommendation), study staff will document this change and the reason for change. Study staff will then categorize participant's intervention status as follows:

1. Transferred According to Randomization ("Intervention Per Protocol") 2. Transferred to Non-Randomized Unit ("As Treated") 3. Discharged Without Receiving Either Intervention ("Observational Only") 2. Our primary analysis will be conducted using an "As Treated" definition, where participant's data will be grouped based on which intervention was received (APIU or YCSU), using the "Intervention Per Protocol" and "As Treated" groups. We will examine any demographic or clinical characteristics between these groups ("Intervention Per Protocol" and "As Treated"), but do not anticipate any differences as these groups will reflect systems-level intervention allocation, which likely will occur by chance. "Observation Only" participants will be excluded from analysis. 3. We will also conduct an Intent-to-Treat defined analysis, in which only participants in the "Intervention Per Protocol" will be included. As such, we will be able to examine the intervention effects under the randomization paradigm. 4. We will conduct exploratory analyses to examine any demographic or clinical differences between the "Intervention Per Protocol" and "As Treated" groups, compared to the "Observational Only" group, to better understand any implications of change in clinical status leading to discharge prior to receiving more intensive care, such as that provided by APIU and YCSU.

• Change from baseline in suicidal ideation and behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 30 days and 3 months [Срок оценки: Baseline, 30 days, 3 months]
• Suicidal behavior and intent on the Pierce Suicide Intent Scale (SIS) based on most recent attempt reported on the C-SSRS at baseline for Pilot Phase only [Срок оценки: Based on most recent attempt from C-SSRS at baseline for Pilot Phase only]
• Change from baseline in acute care services for suicidality on a modified version of the Services Assessment for Children and Adolescents (SACA) at 30 days and 3 months [Срок оценки: Baseline, 30 days, 3 months]
• Change from baseline in hopelessness on the Beck Hopelessness Scale (BHS) at 30 days and 3 months [Срок оценки: Baseline, 30 days, 3 months]
• Change from baseline in psychiatric symptoms and functioning on the DSM-5 Level 1 Cross-Cutting Symptom Measure at 30 days and 3 months [Срок оценки: Baseline, 30 days, 3 months]
• Youth's report of change from baseline in anxiety and depression on the Revised Children's Anxiety and Depression Scale, Short Version (RCADS-25) at post-discharge, 30 days, and 3 months [Срок оценки: Baseline, post-discharge (day of discharge or as soon as possible after intervention ends), 30 days, 3 months]
• Parent's report on youth's change from baseline in anxiety and depression on the Revised Children's Anxiety and Depression Scale, Short Version (RCADS-25) at post-discharge, 30 days, and 3 months [Срок оценки: Baseline, post-discharge (day of discharge or as soon as possible after intervention ends), 30 days, 3 months]
• Therapeutic alliance reported on the Working Alliance Inventory - Short Revised (WAI-SR) at post-discharge [Срок оценки: Post-discharge (day of discharge or as soon as possible after intervention ends)]