Intensive Crisis Intervention
NCT Number: NCT06476886
Acronym: ICI
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Suicide|Suicidal Ideation|Suicide, Attempted|Suicide and Self-harm|Suicide Threat
Interventions: BEHAVIORAL: Intensive Crisis Intervention (ICI)|BEHAVIORAL: Adolescent Psychiatric Inpatient Unit (APIU)
Sponsor: Jennifer Hughes
Collaborators: National Institute of Mental Health (NIMH)|Ohio State University
Sex: ALL
Age: CHILD
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-03
Completion Date: 2026-07-31
Locations: Nationwide Children's Hospital, Columbus, Ohio, 43215, United States

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.

Primary Outcome Measures: 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., 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., 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., Baseline, post-discharge (day of discharge or as soon as possible after intervention ends), 30 days, 3 months
Secondary Outcome Measures: 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., 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, 30 days, and 3 months, 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, 30 days, and 3 months|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., 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, 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., 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., 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., 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)., Post-discharge (day of discharge or as soon as possible after intervention ends)
Other Outcome Measures: Adherence to therapy intervention on the Therapist Behavior Rating Scale - Competence (TBRS-C), 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), 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, 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), 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), 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), 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