Clinical trial NCT06476886: Intensive Crisis Intervention
Official title: Intensive Crisis Intervention (ICI) for Adolescent Suicidal Behavior
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Suicide
Suicidal Ideation
Suicide, Attempted
Suicide and Self-harm
Suicide Threat
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Ohio State University
First posted: 2024-06-27
Enrollment: 180
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

Brief summary: The study's purpose is to improve the clinical management of severe crises experienced by youth with psychiatric disorders by examining a brief, evidence-based alternative to inpatient psychiatric care.

Detailed description: The objective of this study is to refine and test Intensive Crisis Intervention (ICI), a brief, evidence-based treatment that incorporates Family Therapy/Parent Training, Cognitive Behavioral Therapy and Motivational Interviewing to target family functioning in reducing adolescent suicidal behavior. The project's main goal is to examine feasibility, acceptability, research implementation procedures, and preliminary effectiveness of ICI using a mixed-methods approach. The investigators will utilize the extensive catchment area of Nationwide Children's Hospital Behavioral Health (NCH-BH) to complete this work. NCH-BH has a Youth Crisis Stabilization Unit (YCSU) in which ICI can be implemented and compared with outcomes from a traditional adolescent psychiatric inpatient unit (Adolescent Psychiatric Inpatient Unit \[APIU\]).

In Year 1, the investigators will further develop and refine an intervention implementation guide, including a formalized treatment manual, training and supervision protocols, and data collection processes. They will then pilot test implementation of ICI with 20 adolescents divided across the study age range of 12-17 years, 20 parents, and 10 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.

Eligibility criteria: 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 Psychiatric Crisis Department (PCD) with suicidal ideation and/or behavior as the primary referral
3. Be eligible for admission to both YCSU and APIU based on PCD 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 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

Primary outcomes:
measure: Youth's perspective on the value of services received on the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post-discharge (day of discharge or as soon as possible after intervention ends)
measure: Parent's perspective on the value of services received on the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post-discharge (day of discharge or as soon as possible after intervention ends)
measure: 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
timeFrame: Baseline, post-discharge (day of discharge or as soon as possible after intervention ends), 30 days, 3 months
Secondary outcomes:
measure: Change from baseline in suicidal ideation and behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) at 30 days and 3 months
timeFrame: Baseline, 30 days, 3 months
measure: 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
timeFrame: Based on most recent attempt from C-SSRS at baseline for Pilot Phase only
measure: 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
timeFrame: Baseline, 30 days, 3 months
measure: Change from baseline in hopelessness on the Beck Hopelessness Scale (BHS) at 30 days and 3 months
timeFrame: Baseline, 30 days, 3 months
measure: Change from baseline in psychiatric symptoms and functioning on the DSM-5 Level 1 Cross-Cutting Symptom Measure at 30 days and 3 months
timeFrame: Baseline, 30 days, 3 months
measure: 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
timeFrame: Baseline, post-discharge (day of discharge or as soon as possible after intervention ends), 30 days, 3 months
measure: 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
timeFrame: Baseline, post-discharge (day of discharge or as soon as possible after intervention ends), 30 days, 3 months
measure: Therapeutic alliance reported on the Working Alliance Inventory - Short Revised (WAI-SR) at post-discharge
timeFrame: Post-discharge (day of discharge or as soon as possible after intervention ends)
Other outcomes:
measure: Adherence to therapy intervention on the Therapist Behavior Rating Scale - Competence (TBRS-C)
timeFrame: Through study completion
measure: Adherence to therapy intervention on the Cognitive Therapy Rating Scale (CTRS)
timeFrame: Through study completion
measure: Adherence to therapy intervention on the Motivational Interviewing Treatment Integrity (MITI) scale
timeFrame: Through study completion
measure: Hospital staff participants' reports on intervention acceptability on the Acceptability of Intervention Measure (AIM)
timeFrame: Month 14 or 31 of study, dependent on study phase and staff role in study
measure: Hospital staff participants' reports on intervention appropriateness on the Intervention Appropriateness Measure (IAM)
timeFrame: Month 14 or 31 of study, dependent on study phase and staff role in study
measure: Hospital staff participants' reports on intervention feasibility on the Feasibility of Intervention Measure (FIM)
timeFrame: Month 14 or 31 of study, dependent on study phase and staff role in study
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Jennifer L Hughes
role: PRINCIPAL_INVESTIGATOR
References: