Intensive Crisis Intervention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorJennifer Hughes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

213 Participants
are divided into 3 treatment groups
Group A: Intervention Per ProtocolActive comparator 2 interventions
Group B: As TreatedOther 2 interventions
Group C: Observation OnlyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Post-discharge (day of discharge or as soon as possible after intervention ends)
2

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.

Time frame
Post-discharge (day of discharge or as soon as possible after intervention ends)
3

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.

Time frame
Baseline, post-discharge (day of discharge or as soon as possible after intervention ends), 30 days, 3 months

Secondary outcomes

1

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.

Time frame
Baseline, 30 days, 3 months
2

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

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.

Time frame
Based on most recent attempt from C-SSRS at baseline for Pilot Phase only
3

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.

Time frame
Baseline, 30 days, 3 months
4

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

Time frame
Baseline, 30 days, 3 months

Other outcomes

1

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).

Time frame
Through study completion
2

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.

Time frame
Through study completion
3

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.

Time frame
Through study completion
4

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).

Time frame
Month 14 or 31 of study, dependent on study phase and staff role in study

Sponsors and contacts

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Jennifer Hughes

Lead sponsor

Nationwide Children's Hospital

Sponsor institution

National Institute of Mental Health (NIMH)

Collaborator

Ohio State University

Collaborator