Intenzivní krizová intervence (ICI)
Intenzivní krizová intervence (ICI) pro sebevražedné chování dospívajících
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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:
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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.
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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.
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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.
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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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Jennifer L Hughes
- Telefonní číslo: 614-722-6811
- E-mail: jennifer.hughes@nationwidechildrens.org
Studijní záloha kontaktů
- Jméno: Anastasia Berg
- Telefonní číslo: 614-355-7136
- E-mail: Stacie.berg@nationwidechildrens.org
Studijní místa
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Ohio
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Columbus, Ohio, Spojené státy, 43215
- Nábor
- Nationwide Children's Hospital
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Vrchní vyšetřovatel:
- Jennifer L Hughes, PhD
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Kontakt:
- John Psurny
- Telefonní číslo: (614) 355-4132
- E-mail: John.Psurny@nationwidechildrens.org
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: 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.
Ostatní jména:
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.
Ostatní jména:
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Jiný: 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.
Ostatní jména:
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.
Ostatní jména:
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Žádný zásah: Observation Only
Patient participant was discharged without receiving either intervention due to clinical factors |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Youth's perspective on the value of services received on the Client Satisfaction Questionnaire (CSQ-8)
Časové okno: Post-discharge (day of discharge or as soon as possible after intervention ends)
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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)
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Parent's perspective on the value of services received on the Client Satisfaction Questionnaire (CSQ-8)
Časové okno: Post-discharge (day of discharge or as soon as possible after intervention ends)
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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)
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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
Časové okno: Baseline, post-discharge (day of discharge or as soon as possible after intervention ends), 30 days, 3 months
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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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change from baseline in suicidal ideation and behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 30 days and 3 months
Časové okno: Baseline, 30 days, 3 months
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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
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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
Časové okno: Based on most recent attempt from C-SSRS at baseline for Pilot Phase only
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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
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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
Časové okno: Baseline, 30 days, 3 months
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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
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Change from baseline in hopelessness on the Beck Hopelessness Scale (BHS) at 30 days and 3 months
Časové okno: Baseline, 30 days, 3 months
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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
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Change from baseline in psychiatric symptoms and functioning on the DSM-5 Level 1 Cross-Cutting Symptom Measure at 30 days and 3 months
Časové okno: Baseline, 30 days, 3 months
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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
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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
Časové okno: Baseline, post-discharge (day of discharge or as soon as possible after intervention ends), 30 days, 3 months
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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
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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
Časové okno: Baseline, post-discharge (day of discharge or as soon as possible after intervention ends), 30 days, 3 months
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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
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Therapeutic alliance reported on the Working Alliance Inventory - Short Revised (WAI-SR) at post-discharge
Časové okno: Post-discharge (day of discharge or as soon as possible after intervention ends)
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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)
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Adherence to therapy intervention on the Therapist Behavior Rating Scale - Competence (TBRS-C)
Časové okno: Through study completion
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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
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Adherence to therapy intervention on the Cognitive Therapy Rating Scale (CTRS)
Časové okno: Through study completion
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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
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Adherence to therapy intervention on the Motivational Interviewing Treatment Integrity (MITI) scale
Časové okno: Through study completion
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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
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Hospital staff participants' reports on intervention acceptability on the Acceptability of Intervention Measure (AIM)
Časové okno: Month 14 or 31 of study, dependent on study phase and staff role in study
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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
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Hospital staff participants' reports on intervention appropriateness on the Intervention Appropriateness Measure (IAM)
Časové okno: Month 14 or 31 of study, dependent on study phase and staff role in study
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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
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Hospital staff participants' reports on intervention feasibility on the Feasibility of Intervention Measure (FIM)
Časové okno: Month 14 or 31 of study, dependent on study phase and staff role in study
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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
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Jennifer L Hughes, Nationwide Children's Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- STUDY00002867
- 5P50MH127476-02 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Data will be made available through the National Institute of Mental Health (NIMH) Data Archive (NDA) system.
Časový rámec sdílení IPD
The investigators will follow NIMH guidelines for dissemination of study data and related materials.
Kritéria přístupu pro sdílení IPD
To be provided.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
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