Intensive Crisis Intervention

Not Applicable

Recruiting

• Conditions: Suicidal Ideation; Suicide; Suicide, Attempted; Suicide Threat; Suicide and Self-harm

• Registration Number: NCT06476886
• Lead Sponsor: Jennifer Hughes

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-06-03
• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-21
• Study First Posted: 2024-06-27
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-04
• Last Update Posted: 2025-08-07
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

1. Youth between the ages of 12 years 0 months and 17 years 6 months at time of consent
2. Present to the Nationwide Children's Hospital (NCH) Psychiatric Crisis Department (PCD) or NCH Psychiatry Consult Liaison (CL) Service with suicidal ideation and/or behavior as the primary referral
3. Be eligible for admission to both YCSU and APIU based on PCD or CL clinician's clinical judgement
4. Patient and legal guardian must be willing to be admitted to either YCSU or APIU
5. Youth obtains a score of ≥23 on the Concise Health Risk Tracking Self-Report (CHRT-SR)
6. Youth resides with a primary caretaker who has legal authority to consent for participation in research
7. Legal guardian must attend the PCD or CL evaluation

Exclusion Criteria

1. Participants who are unable to understand study procedures (e.g., intellectual disability, actively psychotic)
2. Inability to speak or read English adequately to understand and complete study consent and procedures

YCSU clinicians, PCD staff, and NCH-BH leaders will be invited to participate based on their roles in the system-of-care.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in family functioning on the Systemic Clinical Outcome and Routine Evaluation - 15 (SCORE-15) at post-discharge, 30 days, and 3 month follow-ups	Baseline, post-discharge (day of discharge or as soon as possible after intervention ends), 30 days, 3 months	The SCORE-15 is a self-report measure of family functioning and has been proved to be a reliable and valid index of therapeutic change. The SCORE-15 has 15 Likert scale items (5-point scale; 1=Describes us very well; 5=Describes us not at all), and six separate indicators, three of them qualitative.
Youth's perspective on the value of services received on the Client Satisfaction Questionnaire (CSQ-8)	Post-discharge (day of discharge or as soon as possible after intervention ends)	The Client Satisfaction Questionnaire (CSQ-8) is an 8-item, easily scored and administered measurement that is designed to measure client satisfaction with services. The CSQ-8 uses a 4-point Likert scale. Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction. The items for the CSQ-8 were selected on the basis of ratings by mental health professionals of items that could be related to client satisfaction and by subsequent factor analysis. The CSQ-8 is unidimensional, yielding a homogeneous estimate of general satisfaction with services. The CSQ-8 has been extensively studied, and while it is not necessarily a measure of a client's perceptions of gain from treatment or outcome, it does elicit the client's perspective on the value of services received.
Parent's perspective on the value of services received on the Client Satisfaction Questionnaire (CSQ-8)	Post-discharge (day of discharge or as soon as possible after intervention ends)	The Client Satisfaction Questionnaire (CSQ-8) is an 8-item, easily scored and administered measurement that is designed to measure client satisfaction with services. The CSQ-8 uses a 4-point Likert scale. Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction. The items for the CSQ-8 were selected on the basis of ratings by mental health professionals of items that could be related to client satisfaction and by subsequent factor analysis. The CSQ-8 is unidimensional, yielding a homogeneous estimate of general satisfaction with services. The CSQ-8 has been extensively studied, and while it is not necessarily a measure of a client's perceptions of gain from treatment or outcome, it does elicit the client's perspective on the value of services received.

Secondary Outcome Measures

Name	Time	Method
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	Based on most recent attempt from C-SSRS at baseline for Pilot Phase only	The SIS is a questionnaire that assesses behavior and circumstances surrounding the suicide attempt, including plans, preparation, communicative elements, and concept of lethality of the chosen method.
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	Baseline, 30 days, 3 months	The SACA is a questionnaire completed with parents that asks questions related to any treatment or help the child participant has received for emotional, behavioral, or drug or alcohol problems at baseline. The SACA is then updated at 30 day and 3 month follow-ups to assess for any change in mental health service utilization since last visit.
Change from baseline in hopelessness on the Beck Hopelessness Scale (BHS) at 30 days and 3 months	Baseline, 30 days, 3 months	The Beck Hopelessness Scale (BHS) examines an individual's thoughts and beliefs about the future. The 20 true-false items measure three major aspects of hopelessness: feelings about the future, loss of motivation, and expectations. Scores on the BHS range from 0 to 20, with higher total scores indicating greater hopelessness. The hopelessness construct is highly correlated with measures of depression, suicidal intent, and ideation
Change from baseline in psychiatric symptoms and functioning on the DSM-5 Level 1 Cross-Cutting Symptom Measure at 30 days and 3 months	Baseline, 30 days, 3 months	The DSM-5 Level 1 Cross-Cutting Symptom Measure assesses mental health domains that are important across psychiatric diagnoses. This child-rated version of the measure consists of 25 questions that assess 12 psychiatric domains, including depression, anger, irritability, mania, anxiety, somatic symptoms, inattention, suicidal ideation/attempt, psychosis, sleep disturbance, repetitive thoughts and behaviors, and substance use. Each item asks the child, age 11-17, or parent/caregiver to rate how much (or how often) the child has been bothered by the specific symptom during the past 2 weeks. The measure was found to be clinically useful and had good test-retest reliability. Nineteen of the items are rated on a 5-point scale (0=none or not at all; 1=slight or rare, less than a day or two; 2=mild or several days; 3=moderate or more than half the days; and 4=severe or nearly every day). The suicidal ideation, suicide attempt, and substance abuse items are each rated on a "Yes or No" scale.
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	Baseline, post-discharge (day of discharge or as soon as possible after intervention ends), 30 days, 3 months	The Revised Children's Anxiety and Depression Scale-25 (RCADS-25) is a 25-item scale that measures levels of anxiety and low mood. The scale has two subscales (Total Anxiety and Total Depression) and an overall score. Both the anxiety and depression subscales have strong relation to anxiety and depression diagnostic groups. All items assess the frequency of symptoms and are rated on a 4-point Likert scale (1=Never; 4=Always). The child self-report scale can be used by children and adolescents between the ages of 8 to 18.
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	Baseline, post-discharge (day of discharge or as soon as possible after intervention ends), 30 days, 3 months	The Revised Children's Anxiety and Depression Scale-25 (RCADS-25) is a 25-item scale that measures levels of anxiety and low mood. The scale has two subscales (Total Anxiety and Total Depression) and an overall score. Both the anxiety and depression subscales have strong relation to anxiety and depression diagnostic groups. All items assess the frequency of symptoms and are rated on a 4-point Likert scale (1=Never; 4=Always). A parent (or caregiver) version is available to rate a child or adolescent's level of anxiety and depressive symptoms based on personal observations.
Therapeutic alliance reported on the Working Alliance Inventory - Short Revised (WAI-SR) at post-discharge	Post-discharge (day of discharge or as soon as possible after intervention ends)	The Working Alliance Inventory-Short Revised (WAI-SR) is a 12-item measure for the assessment of the therapeutic alliance. The WAI-SR captures three key alliance aspects: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. The WAI-SR uses a 5-point Likert Scale (1=Seldom; 5=Always).
Change from baseline in suicidal ideation and behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 30 days and 3 months	Baseline, 30 days, 3 months	The C-SSRS is a validated, semi-structured interview that assesses both suicidal behavior and suicidal ideation (yes/no, frequency), with flexible time points and multiple informants depending on administrator purpose and need.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States