Intensive Crisis Intervention

NCT06476886 | Recruiting DMC

• 2 other identifiers: STUDY000028675P50MH127476-02
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide; Suicidal Ideation; Suicide, Attempted; Suicide and Self-harm; Suicide Threat

Outcome Measures

Primary Outcomes (3)

• 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 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

  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

  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

  Baseline, 30 days, 3 months

• Change from baseline in hopelessness on the Beck Hopelessness Scale (BHS) at 30 days and 3 months

  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

  Baseline, 30 days, 3 months

Other Outcomes (6)

• Adherence to therapy intervention on the Therapist Behavior Rating Scale - Competence (TBRS-C)

  Through study completion

• Adherence to therapy intervention on the Cognitive Therapy Rating Scale (CTRS)

  Through study completion

• Adherence to therapy intervention on the Motivational Interviewing Treatment Integrity (MITI) scale

  Through study completion

Study Arms (3)

Intervention Per Protocol

ACTIVE COMPARATOR

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

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.

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

Interventions

Intensive Crisis Intervention (ICI) BEHAVIORAL

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.

Also known as: ICI

As Treated; Intervention Per Protocol

Adolescent Psychiatric Inpatient Unit (APIU) BEHAVIORAL

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.

Also known as: APIU

As Treated; Intervention Per Protocol

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jennifer Hughes: lead
• National Institute of Mental Health (NIMH): collaborator
• Ohio State University: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43215, United States

RECRUITING

MeSH Terms

Conditions

Suicide; Suicidal Ideation; Suicide, Attempted; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Jennifer L Hughes

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer L Hughes

CONTACT

614-722-6811; jennifer.hughes@nationwidechildrens.org

Anastasia Berg

CONTACT

614-355-7136; Stacie.berg@nationwidechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blind to treatment assignment. It is not possible for clinicians or families to be blind to treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Psychologist & Clinical Scholar, Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 27, 2024
• Study Start: June 3, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The investigators will follow NIMH guidelines for dissemination of study data and related materials.
• Access Criteria: To be provided.

Locations

US (1)