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强化危机干预 (ICI)

2026年9月17日 更新者:Jennifer Hughes

针对青少年自杀行为的强化危机干预(ICI)

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.

研究概览

详细说明

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 ("Intervention Not Per Protocol")*
    3. 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.
  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 "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.

  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 "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.

研究类型

介入性

注册 (估计的)

213

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Ohio
      • Columbus、Ohio、美国、43215
        • 招聘中
        • Nationwide Children's Hospital
        • 首席研究员:
          • Jennifer L Hughes, PhD
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 17年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Intervention Per Protocol

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

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.

其他名称:
  • ICI

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.

其他名称:
  • APIU
其他:As Treated

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

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.

其他名称:
  • ICI

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.

其他名称:
  • APIU
无干预:Observation Only

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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Youth's perspective on the value of services received on the Client Satisfaction Questionnaire (CSQ-8)
大体时间: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.

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)
大体时间: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.

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
大体时间: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.

Baseline, post-discharge (day of discharge or as soon as possible after intervention ends), 30 days, 3 months

次要结果测量

结果测量
措施说明
大体时间
Change from baseline in suicidal ideation and behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 30 days and 3 months
大体时间: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.

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
大体时间: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.

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
大体时间: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.

Baseline, 30 days, 3 months
Change from baseline in hopelessness on the Beck Hopelessness Scale (BHS) at 30 days and 3 months
大体时间: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

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
大体时间: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.

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
大体时间: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.

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
大体时间: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.

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
大体时间: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).

Post-discharge (day of discharge or as soon as possible after intervention ends)

其他结果措施

结果测量
措施说明
大体时间
Adherence to therapy intervention on the Therapist Behavior Rating Scale - Competence (TBRS-C)
大体时间:Through study completion

The Therapist Behavior Rating scale is an adherence process coding instrument designed to identify core therapeutic techniques and behaviors in facilitating multidimensional family therapy. This study uses just the 4-item Competence subscale of the measure to rate the therapy adherence. The instrument uses a 7-point Likert scale (1=Not at all; 7=Extensively).

Through study completion
Adherence to therapy intervention on the Cognitive Therapy Rating Scale (CTRS)
大体时间:Through study completion

The Cognitive Therapy Rating Scale (CTRS) is an observer-rated measure of cognitive behavioral therapy treatment fidelity. The instrument uses a 7-point Likert scale (0=Poor; 6=Excellent) for 11 therapy skill-specific items, with 7 additional items of varying scales and 2 text fill-in items to rate overall treatment.

Through study completion
Adherence to therapy intervention on the Motivational Interviewing Treatment Integrity (MITI) scale
大体时间:Through study completion

The Motivational Interviewing Treatment Integrity (MITI) coding instrument is an observer-rated measure of motivational interviewing treatment fidelity. The MITI includes 4 global score items using a 5-point rating scale and 10 behavior count items. Global scores range from a minimum of "1" and a maximum of "5." Higher scores on the global scores and higher behavior counts indicate greater fidelity to the motivational interviewing treatment.

Through study completion
Hospital staff participants' reports on intervention acceptability on the Acceptability of Intervention Measure (AIM)
大体时间:Month 14 or 31 of study, dependent on study phase and staff role in study

The Acceptability of Intervention Measure (AIM) is a widely used 4-item measure that can be administered to a wide range of stakeholders to determine the extent to which they believe an intervention is acceptable. The measure uses a 5-point Likert scale (1=Completely disagree; 5=Completely agree).

Month 14 or 31 of study, dependent on study phase and staff role in study
Hospital staff participants' reports on intervention appropriateness on the Intervention Appropriateness Measure (IAM)
大体时间:Month 14 or 31 of study, dependent on study phase and staff role in study

The Intervention Appropriateness Measure (IAM) is a widely used 4-item measure that can be administered to a wide range of stakeholders to determine the extent to which they believe an intervention is appropriate. The measure uses a 5-point Likert scale (1=Completely disagree; 5=Completely agree).

Month 14 or 31 of study, dependent on study phase and staff role in study
Hospital staff participants' reports on intervention feasibility on the Feasibility of Intervention Measure (FIM)
大体时间:Month 14 or 31 of study, dependent on study phase and staff role in study

The Feasibility of Intervention Measure (FIM) is a widely used 4-item measure that can be administered to a wide range of stakeholders to determine the extent to which they believe an intervention is feasible. The measure uses a 5-point Likert scale (1=Completely disagree; 5=Completely agree).

Month 14 or 31 of study, dependent on study phase and staff role in study

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jennifer L Hughes、Nationwide Children's Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年6月3日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年7月31日

研究注册日期

首次提交

2024年6月11日

首先提交符合 QC 标准的

2024年6月21日

首次发布 (实际的)

2024年6月27日

研究记录更新

最后更新发布 (实际的)

2026年9月21日

上次提交的符合 QC 标准的更新

2026年9月17日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • STUDY00002867
  • 5P50MH127476-02 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Data will be made available through the National Institute of Mental Health (NIMH) Data Archive (NDA) system.

IPD 共享时间框架

The investigators will follow NIMH guidelines for dissemination of study data and related materials.

IPD 共享访问标准

To be provided.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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