Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-24
SponsorJohns Hopkins University
About this trial
The study will compare the effectiveness of two relatively brief and scalable evidence-based interventions: the Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+), a suicide-specific intervention that helps people prevent suicidal crises from escalating, and Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI), a psychotherapeutic crisis intervention treatment for suicidal adolescents that teaches youth skills to prevent suicidal crises and addresses interpersonal problems that lead to suicidal crises. The results will inform the future standard of care for youth at risk for suicide presenting in the ED setting. This project focuses on suicidal youth ages 12-24 in five ethnically and racially diverse urban areas: Philadelphia, Pennsylvania; Baltimore, Maryland; Chapel Hill, North Carolina; St. Petersburg, Florida; and Northern Manhattan/lower Bronx/eastern Queens communities in New York City, New York.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Suicide Risk During Acute Care Visit (At least one item in risk assessment is required; check all that apply): ___ Chief complaint of suicide-related concern (via Medical Record/Other), ___ Active suicidal ideation endorsed in past 1 month on validated suicide screener, ___ Suicidal behavior in the past 3 months on validated suicide screener, ___ Clinician indicated SI in past month or SA in past 3 months.
Have access to a cellular phone with the ability to receive phone calls and text messages over the 12-month follow- up period
Adolescent must be verbally fluent and can communicate, understand, and read in either English or Spanish
Adolescent has been/will be discharged from a higher level of care (i.e. inpatient, day hospital, partial hospitalization program (PHP), or residential treatment program) and back in the community within 4 weeks of their acute care visit. [Note: this criterion does not apply to all patients - select N/A if this is the case.
Disqualifiers
Significant cognitive or developmental delays that prevent understanding or using SPI+ or IPT-A-SCI (includes inability to communicate verbally)
Altered mental status (acute psychosis, intoxication, or mania)
Unable or unwilling to provide informed consent (adults), assent (minors), or permission (parents/caregivers)
The services offered through the study are not in the best clinical interest of the patient (e.g., presenting problem requires a different level of care or treatment approach).
Trial design
Design model
Parallel
Treatments tested in this trial
Stanley Brown Safety Planning Intervention and Follow-up Contacts (SPI+)
BehavioralStanley Brown Safety Planning completed in the emergency department with 3 follow-up contacts after discharge
Interpersonal Psychotherapy for Adolescents Ultra Short Crisis Intervention (IPT-A SCI)
BehavioralFive session crisis focused version of IPT for adolescents.
Treatment groups
484 Participants
are divided into 2 treatment groupsGroup A: Safety Planning InterventionActive comparator 1 intervention
Group B: Ultra-Brief Crisis IPT-AActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Suicidal ideation as assessed by the Suicide Assessment Five-step Evaluation and Triage (SAFE-T) with Columbia-Suicide Severity Rating Scale (C-SSRS) Recent
Suicidal thoughts: measured using the Suicide Assessment Five-step Evaluation and Triage (SAFE-T) with Columbia-Suicide Severity Rating Scale (C-SSRS) Recent. Scores for suicidal ideation range from 0 to 5, with higher scores indicating more serious suicidal ideation, where 0 = "no suicidal thoughts"; 1= "wish to be dead"; 2 = "nonspecific active suicidal thoughts"; 3 = "suicidal thoughts with methods"; 4 = "suicidal intent"; and 5 = "suicidal intent with plan".
Time frame
baseline, 3 months, 6 months, 12 months2
Change in Suicidal behavior as assessed by the Suicide Assessment Five-step Evaluation and Triage (SAFE-T) with Columbia-Suicide Severity Rating Scale (C-SSRS) Recent
Suicidal behavior with intent to die: measured using the Suicide Assessment Five-step Evaluation and Triage (SAFE-T) with Columbia-Suicide Severity Rating Scale (C-SSRS) Recent. Scored 0 to 1, with 1 indicating a suicide attempt since last assessment.
Time frame
baseline, 3 months, 6 months, 12 months3
Number of Suicides
Measured through Death Records or Suicide from Office of Chief Medical Examiner, family report or medical record
Time frame
12 monthsSecondary outcomes
1
Change in Frequency of mental health service utilization as assessed by Services Assessment for Children and Adolescents (SACA)
Services Assessment for Children and Adolescents (SACA) use of inpatient, outpatient, school services since last assessment. Items are dichotomous (yes/no) and the scale ranges from 0 (no services) to 3 (3 types of services), higher numbers indicate more services.
Time frame
baseline, 3 months, 6 months, 12 months2
Change in Self reported Quality of Life as assessed by the Euro-Qol 5-Dimension 3-level tool (EQ-5D-3L)
Euro-Qol 5-Dimension 3-level tool (EQ-5D-3L) for young adults. The scale consists of a descriptive system that comprises five items referring to the domains mobility, self-care, usual activities, pain/discomfort and anxiety/depression scored as presenting no problems, moderate problems or severe problems. Each of the five items (range 0-2) with higher scores indicating better quality of life. A component of this scale is the EuroQol visual analogue scale (EQ-VAS) which participants can use a number from 0 (the worst) -100 (the best health state imaginable).
Time frame
baseline, 3 months, 6 months, 12 months3
Change in Self reported Quality of Life as assessed by the Euro-Qol 5-Dimension Youth (EQ-5D-Y)
Quality of Life will be assessed by the Euro-Qol 5-Dimension Youth (EQ-5D-Y). The scale consists of a descriptive system that comprises five items referring to the domains mobility, self-care, usual activities, pain/discomfort and anxiety/depression scored as presenting no problems, moderate problems or severe problems. Each of the five items (range 0-2) with higher scores indicating better quality of life. A component of this scale is the EuroQol visual analogue scale (EQ-VAS) which participants can use a number from 0 (the worst) -100 (the best health state imaginable).
Time frame
baseline, 3 months, 6 months, 12 months4
Change in Generalized Anxiety Disorder as assessed by the The Generalized Anxiety Disorder 7 question scale (GAD-7).
Generalized Anxiety Disorder will be assessed by the GAD 7 question scale. The Generalized Anxiety Disorder 7 is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. The GAD-7 total score ranges from 0 to 21 with clinical categorizations of anxiety levels as follows: GAD-7 score of 0-4 (none), 5-9 (mild), 10-14 (moderate), and 15-21 (severe).
Time frame
baseline, 3 months, 6 months, 12 monthsSponsors and contacts
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Johns Hopkins University
Lead sponsor
Johns Hopkins All Children's Hospital
Collaborator
Children's Hospital of Philadelphia
Collaborator
Reichman University
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator
Columbia University
Collaborator
Source ClinicalTrials.gov