Clinical trial NCT03016572: Promote Access to Stop Suicide: Comparison of Follow up Services for Youth at Risk for Suicide
Official title: PASS (Promote Access to Stop Suicide): A Randomized Controlled Trial Comparing Enhanced Treatment as Usual, Crisis Center Follow up and Wraparound Services for Youth at Risk for Suicide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Depressive Disorder, Major
Anxiety Disorders
Suicidal Ideation
Suicidal Impulses
Keywords: Suicide
Adolescent
Intervention
Crisis
Follow-Up
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
First posted: 2017-01-10
Enrollment: 65
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This research study is designed to answer specific questions about new ways to provide services for youth at-risk of suicide.

Detailed description: The proposed project will be able to provide services to high-risk youth in Ohio. This randomized controlled trial for youth discharged from inpatient psychiatric hospital will be able to determine what combination of services is best suited to reduce subsequent suicide attempts and re-hospitalization.

All youth (ages 10-18), that fit the inclusion criteria, will be recruited from the inpatient unit at Fairview Youth Inpatient Unit. Patients will be consented, enrolled, and assigned to group by the Research Coordinator working at the unit. The Methodologist/ Statistician will generate a random allocation sequence using random number generator and communicate group assignment to the Research Coordinator. There will not be any restriction on randomization. The PI will be blinded to all group assignments.

The clinical research tools and screens that will be administered in this study include: Columbia-Suicide Severity Rating Scale (C-SSRS), The Suicidal Ideation Questionnaire (SIQ), The Adverse Childhood Experiences (ACEs), Ohio Scales, Children's Global Assessment Scale (CGAS), Clinical Global Impressions (CGI-I).

The participants of the study will be seen by the child psychiatrist (Dr. Varkula) and the research coordinator at the initial appointment, and a 6 month follow-up (Dr. Falcone). The C-SSRS and the SIQ will be administered at the initial appointment and the follow-up appointment. The study's research coordinator will be regulating the 3 month phone call and scheduling the 6 month up visit and administering the Ohio Scales questionnaire with the parents and/ or guardians of the child. There will also be a 12 month follow-up phone call conducted by the research coordinator. During this time, the information for the C-SSRS questionnaire, the SIQ, the Ohio Scales (for both the parent and the child), the CGI-I, and the CGAS will be administered.

Eligibility criteria: Inclusion Criteria:

* All patients (ages 10-18 years) admitted to the Cleveland Clinic Inpatient Child and Adolescent psychiatry unit after a suicide ideation, behavior, or attempt.
* This can be defined by any intentional, nonfatal self-injury, regardless of medical lethality, will be consider a suicide attempt if intent to die was indicated.
* Signed consent by the adult patient (18 years) or by a first-degree relative or a guardian (for children) at the time of enrollment in the study, and assent by the children as soon as is feasible.

Exclusion Criteria:

* Patients with a known history of autistic spectrum disorder, non-verbal patients and moderate or severe mental retardation (IQ less than 70 and those patients in special education full time), patients with substance dependency and patients with schizophrenia.
* Patients who are enrolled in case management will also be excluded from the study.

Primary outcomes:
measure: Frequency of repeat suicide attempts in adolescents.
timeFrame: up to 12 months post-discharge
Secondary outcomes:
measure: Frequency of readmissions after a suicide attempt in adolescents.
timeFrame: up to 12 months post-discharge
measure: Relation between service type and frequency of repeat suicide attempts in adolescents.
timeFrame: up to 12 months post-discharge
measure: Relation between service type and frequency of readmissions after a suicide attempt in adolescents.
timeFrame: up to 12 months post-discharge
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Fairview Hospital
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Tatiana Falcone, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brent DA, Oquendo M, Birmaher B, Greenhill L, Kolko D, Stanley B, Zelazny J, Brodsky B, Firinciogullari S, Ellis SP, Mann JJ. Peripubertal suicide attempts in offspring of suicide attempters with siblings concordant for suicidal behavior. Am J Psychiatry. 2003 Aug;160(8):1486-93. doi: 10.1176/appi.ajp.160.8.1486.
citation: Gould MS, Greenberg T, Velting DM, Shaffer D. Youth suicide risk and preventive interventions: a review of the past 10 years. J Am Acad Child Adolesc Psychiatry. 2003 Apr;42(4):386-405. doi: 10.1097/01.CHI.0000046821.95464.CF.
citation: Nock MK, Green JG, Hwang I, McLaughlin KA, Sampson NA, Zaslavsky AM, Kessler RC. Prevalence, correlates, and treatment of lifetime suicidal behavior among adolescents: results from the National Comorbidity Survey Replication Adolescent Supplement. JAMA Psychiatry. 2013 Mar;70(3):300-10. doi: 10.1001/2013.jamapsychiatry.55.
citation: Torio CM, Encinosa W, Berdahl T, McCormick MC, Simpson LA. Annual report on health care for children and youth in the United States: national estimates of cost, utilization and expenditures for children with mental health conditions. Acad Pediatr. 2015 Jan-Feb;15(1):19-35. doi: 10.1016/j.acap.2014.07.007. Epub 2014 Nov 13.
citation: Gould MS, Kalafat J, Harrismunfakh JL, Kleinman M. An evaluation of crisis hotline outcomes. Part 2: Suicidal callers. Suicide Life Threat Behav. 2007 Jun;37(3):338-52. doi: 10.1521/suli.2007.37.3.338.
citation: Busch KA, Fawcett J, Jacobs DG. Clinical correlates of inpatient suicide. J Clin Psychiatry. 2003 Jan;64(1):14-9. doi: 10.4088/jcp.v64n0105.