SuicideICINCT06476886
Intensive Crisis Intervention
A study testing Intensive Crisis Intervention (ICI) and Adolescent Psychiatric Inpatient Unit (APIU) in people with Suicide and Suicidal Ideation, run by Jennifer Hughes at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Suicide, Suicidal Ideation, Suicide, Attempted
- What is being tested?
- Intensive Crisis Intervention (ICI) and Adolescent Psychiatric Inpatient Unit (APIU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Youth between the ages of 12 years 0 months and 17 years 6 months at time of consent
- 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
- Be eligible for admission to both YCSU and APIU based on PCD or CL clinician's clinical judgement
- Patient and legal guardian must be willing to be admitted to either YCSU or APIU
- Youth obtains a score of ≥23 on the Concise Health Risk Tracking Self-Report (CHRT-SR)
- Youth resides with a primary caretaker who has legal authority to consent for participation in research
- Legal guardian must attend the PCD or CL evaluation
Who cannot join
- Participants who are unable to understand study procedures (e.g., intellectual disability, actively psychotic)
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43215
John Psurny, (614) 355-4132, John.Psurny@nationwidechildrens.org
Jennifer L Hughes, PhD
About this study
Official title: Intensive Crisis Intervention (ICI) for Adolescent Suicidal Behavior
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.
Read the 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:
- There is a waitlist or longer wait time for the assigned unit.
- A patient's clinical presentation changes and the treatment team's recommendations for care change.
- 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:
- 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:
- Transferred According to Randomization ("Intervention Per Protocol")
- Transferred to Non-Randomized Unit ("Intervention Not Per Protocol")*
- Discharged Without Receiving Either Intervention ("Observational Only") *Note: A prior version of this project referred to this group as "As Treated," but the group name has been updated to "Intervention Not Per Protocol" for ease of understanding.
- 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 "Intervention Not Per Protocol" groups. We will examine any demographic or clinical characteristics between these groups ("Intervention Per Protocol" and "Intervention Not Per Protocol"), 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.
- 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.
- We will conduct exploratory analyses to examine any demographic or clinical differences between the "Intervention Per Protocol" and "Intervention Not Per Protocol" 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.
- Being tested
- Intensive Crisis Intervention (ICI), Adolescent Psychiatric Inpatient Unit (APIU)
- Medical subject headings
- Suicide, Suicidal Ideation, Suicide, Attempted, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Crisis Intervention (ICI)Behavioural
Also called ICI
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.
Adolescent Psychiatric Inpatient Unit (APIU)Behavioural
Also called APIU
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Per Protocol | Active comparator | Patient participant was transferred to either YCSU or APIU according to randomization Receives: Behavioral: Intensive Crisis Intervention (ICI); Behavioral: Adolescent Psychiatric Inpatient Unit (APIU) |
| As Treated | Other | Patient participant transferred to a non-randomized unit, either YCSU or APIU, due to clinical or hospital system factors. Receives: Behavioral: Intensive Crisis Intervention (ICI); Behavioral: Adolescent Psychiatric Inpatient Unit (APIU) |
| Observation Only | No intervention | Patient participant was discharged without receiving either intervention due to clinical factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Youth's perspective on the value of services received on the Client Satisfaction Questionnaire (CSQ-8)
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.
Measured: Post-discharge (day of discharge or as soon as possible after intervention ends)
Parent's perspective on the value of services received on the Client Satisfaction Questionnaire (CSQ-8)
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.
Measured: Post-discharge (day of discharge or as soon as possible after intervention ends)
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
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.
Measured: Baseline, post-discharge (day of discharge or as soon as possible after intervention ends), 30 days, 3 months
Secondary outcomes (8)
Change from baseline in suicidal ideation and behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 30 days and 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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, 30 days, 3 months
Change from baseline in hopelessness on the Beck Hopelessness Scale (BHS) at 30 days and 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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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).
Measured: Post-discharge (day of discharge or as soon as possible after intervention ends)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start3 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Pilot Phase will consist of 20 youth admitted to YCSU and their parents receiving ICI. In the RCT, 60 youth will be randomized in a 1:1 ratio to YCSU (n=30) or APIU (n=30).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jennifer Hughes
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Ohio State University
- Responsible party
- Sponsor-investigator, Jennifer Hughes, Nationwide Children's Hospital
- Investigators
- Jennifer L Hughes, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06476886
- Sponsor's protocol ID
- STUDY00002867
- Other IDs
- 5P50MH127476-02
- Acronym
- ICI
- Status last verified
- Sep 2026
- First submitted
- 11 Jun 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available through the National Institute of Mental Health (NIMH) Data Archive (NDA) system.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Crisis Intervention (ICI) for Adolescent Suicidal Behavior
- ClinicalTrials.gov ID
- NCT06476886
- Acronym / sponsor ID
- ICI / STUDY00002867
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Jennifer HughesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Ohio State University
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- There is a waitlist or longer wait time for the assigned unit.
- A patient's clinical presentation changes and the treatment team's recommendations for care change.
- 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:
- 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:
- Transferred According to Randomization ("Intervention Per Protocol")
- Transferred to Non-Randomized Unit ("Intervention Not Per Protocol")*
- Discharged Without Receiving Either Intervention ("Observational Only") *Note: A prior version of this project referred to this group as "As Treated," but the group name has been updated to "Intervention Not Per Protocol" for ease of understanding.
- 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 "Intervention Not Per Protocol" groups. We will examine any demographic or clinical characteristics between these groups ("Intervention Per Protocol" and "Intervention Not Per Protocol"), 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.
- 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.
- We will conduct exploratory analyses to examine any demographic or clinical differences between the "Intervention Per Protocol" and "Intervention Not Per Protocol" 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The Pilot Phase will consist of 20 youth admitted to YCSU and their parents receiving ICI. In the RCT, 60 youth will be randomized in a 1:1 ratio to YCSU (n=30) or APIU (n=30).
| Arm | Type | Receives |
|---|---|---|
| Intervention Per Protocol | Active comparator | Behavioral: Intensive Crisis Intervention (ICI), Behavioral: Adolescent Psychiatric Inpatient Unit (APIU)Patient participant was transferred to either YCSU or APIU according to randomization |
| As Treated | Other | Behavioral: Intensive Crisis Intervention (ICI), Behavioral: Adolescent Psychiatric Inpatient Unit (APIU)Patient participant transferred to a non-randomized unit, either YCSU or APIU, due to clinical or hospital system factors. |
| Observation Only | No intervention | –Patient participant was discharged without receiving either intervention due to clinical factors |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Youth between the ages of 12 years 0 months and 17 years 6 months at time of consent
- 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
- Be eligible for admission to both YCSU and APIU based on PCD or CL clinician's clinical judgement
- Patient and legal guardian must be willing to be admitted to either YCSU or APIU
- Youth obtains a score of ≥23 on the Concise Health Risk Tracking Self-Report (CHRT-SR)
Key exclusion criteria (3 listed)
- Participants who are unable to understand study procedures (e.g., intellectual disability, actively psychotic)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Crisis Intervention (ICI)Also: ICIICI 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. | Behavioural | As Treated, Intervention Per Protocol |
| Adolescent Psychiatric Inpatient Unit (APIU)Also: APIUAPIU 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. | Behavioural | As Treated, Intervention Per Protocol |
Primary outcome
Youth's perspective on the value of services received on the Client Satisfaction Questionnaire (CSQ-8)
Time frame: 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)
Time frame: 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.
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
Time frame: 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.
8 secondary outcomes
Change from baseline in suicidal ideation and behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 30 days and 3 months
Time frame: 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
Time frame: 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
Time frame: Baseline, 30 days, 3 months
Change from baseline in hopelessness on the Beck Hopelessness Scale (BHS) at 30 days and 3 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Post-discharge (day of discharge or as soon as possible after intervention ends)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Yes. Data will be made available through the National Institute of Mental Health (NIMH) Data Archive (NDA) system.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer L Hughes principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Crisis Intervention (ICI) and Adolescent Psychiatric Inpatient Unit (APIU) in people with Suicide and Suicidal Ideation, run by Jennifer Hughes at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer L Hughes (614-722-6811, jennifer.hughes@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Youth's perspective on the value of services received on the Client Satisfaction Questionnaire (CSQ-8) (time frame: Post-discharge (day of discharge or as soon as possible after intervention ends)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.