Recruiting

Observational Study

Sponsor:

Jennifer Hughes

Code:

NCT06476886

Conditions

Suicide

Suicidal Ideation

Suicide, Attempted

Suicide and Self-harm

Suicide Threat

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Intensive Crisis Intervention (ICI)

Adolescent Psychiatric Inpatient Unit (APIU)

Study Details

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

Study ID

NCT06476886

Start date

Jun 3, 2024

Status verified date

Sep, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

213 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intervention Per Protocol

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

other: As Treated

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

no intervention: Observation Only

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

Interventions

Intensive Crisis Intervention (ICI)

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.

Adolescent Psychiatric Inpatient Unit (APIU)

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.

Primary outcome measure

  • Youth's perspective on the value of services received on the Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Baseline, post-discharge (day of discharge or as soon as possible after intervention ends), 30 days, 3 months ]

Central Contacts and Locations

Central contacts

Jennifer L Hughes

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

Anastasia Berg

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

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43215

Contacts

John Psurny

(614) 355-4132John.Psurny@nationwidechildrens.org

Principal Investigator:

Jennifer L Hughes, PhD

More Information

Sponsor

Jennifer Hughes

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Jennifer Hughes on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.