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Promote Access to Stop Suicide: Comparison of Follow up Services for Youth at Risk for Suicide (PASS)

Primary Purpose

Suicide, Depressive Disorder, Major, Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care
Crisis Intervention
Wraparound Services
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide focused on measuring Suicide, Adolescent, Intervention, Crisis, Follow-Up

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cleveland Clinic Fairview Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Enhanced Treatment As Usual (E-TAU)

TAU + Crisis Center (CC) Follow Up

TAU + CC Follow Up + Wraparound Services

Arm Description

The patient will be referred for regular (Standard of Care) outpatient psychiatry/ psychology services or continue with the services that they were receiving prior to admission. They will be followed up by calling patient families at 3 months (post their initial appointment) and at 12 months. They will also have 1 research visit at 6 months (with Dr. Falcone), which they will schedule during their 3 month follow-up call; the Suicide Ideation Questionnaire (SIQ) will be administered. The patients assigned to this group will also be receiving 10 caring follow-up post cards at the following weeks and months (post-discharge from the inpatient unit): 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months, 5 months, 7 months, 9 months, 12 months, and on the patient's birthday.

Frontline Services will be administering (at least 9) crisis intervention phone calls to the patients; more calls will be made if they feel it is necessary for the safety and health of the patient. Follow up calls will ask the patient questions about following up in the future, whether they have had thoughts about suicide, whether they are in imminent danger of suicide by the end of the call, and whether the patient is stable. At the end of the call, the patient will be asked to rate their suicidality on a scale of 1 to 10.

This group will be linked with a care coordinator through Tapestry services. Wraparound is an intensive, individualized care coordination and treatment planning process that involves all of the important people in a child's life to work together to make the child successful in school, at home and in the community.

Outcomes

Primary Outcome Measures

Frequency of repeat suicide attempts in adolescents.
Frequency of repeat suicide attempts during the 12 month follow up

Secondary Outcome Measures

Frequency of readmissions after a suicide attempt in adolescents.
Frequency of readmissions after a suicide attempt in adolescents
Relation between service type and frequency of repeat suicide attempts in adolescents.
Comparing the frequency of repeat suicide attempts in adolescents among the 3 service type treatment arms.
Relation between service type and frequency of readmissions after a suicide attempt in adolescents.
Comparing the frequency of readmissions after a suicide attempt in adolescents among the 3 service type treatment arms.

Full Information

First Posted
January 5, 2017
Last Updated
September 10, 2021
Sponsor
The Cleveland Clinic
Collaborators
Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT03016572
Brief Title
Promote Access to Stop Suicide: Comparison of Follow up Services for Youth at Risk for Suicide
Acronym
PASS
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 4, 2017 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
Case Western Reserve University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Depressive Disorder, Major, Anxiety Disorders, Suicidal Ideation, Suicidal Impulses
Keywords
Suicide, Adolescent, Intervention, Crisis, Follow-Up

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Treatment As Usual (E-TAU)
Arm Type
Experimental
Arm Description
The patient will be referred for regular (Standard of Care) outpatient psychiatry/ psychology services or continue with the services that they were receiving prior to admission. They will be followed up by calling patient families at 3 months (post their initial appointment) and at 12 months. They will also have 1 research visit at 6 months (with Dr. Falcone), which they will schedule during their 3 month follow-up call; the Suicide Ideation Questionnaire (SIQ) will be administered. The patients assigned to this group will also be receiving 10 caring follow-up post cards at the following weeks and months (post-discharge from the inpatient unit): 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months, 5 months, 7 months, 9 months, 12 months, and on the patient's birthday.
Arm Title
TAU + Crisis Center (CC) Follow Up
Arm Type
Experimental
Arm Description
Frontline Services will be administering (at least 9) crisis intervention phone calls to the patients; more calls will be made if they feel it is necessary for the safety and health of the patient. Follow up calls will ask the patient questions about following up in the future, whether they have had thoughts about suicide, whether they are in imminent danger of suicide by the end of the call, and whether the patient is stable. At the end of the call, the patient will be asked to rate their suicidality on a scale of 1 to 10.
Arm Title
TAU + CC Follow Up + Wraparound Services
Arm Type
Experimental
Arm Description
This group will be linked with a care coordinator through Tapestry services. Wraparound is an intensive, individualized care coordination and treatment planning process that involves all of the important people in a child's life to work together to make the child successful in school, at home and in the community.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care
Intervention Description
Follow-Up Calls, Questionnaires
Intervention Type
Behavioral
Intervention Name(s)
Crisis Intervention
Intervention Description
Frontline Services will be administering follow up phone calls for participants of the study, recently discharged from the emergency room.
Intervention Type
Behavioral
Intervention Name(s)
Wraparound Services
Intervention Description
Tapestry will be assigning case management services for participants randomized into the third arm of the study.
Primary Outcome Measure Information:
Title
Frequency of repeat suicide attempts in adolescents.
Description
Frequency of repeat suicide attempts during the 12 month follow up
Time Frame
up to 12 months post-discharge
Secondary Outcome Measure Information:
Title
Frequency of readmissions after a suicide attempt in adolescents.
Description
Frequency of readmissions after a suicide attempt in adolescents
Time Frame
up to 12 months post-discharge
Title
Relation between service type and frequency of repeat suicide attempts in adolescents.
Description
Comparing the frequency of repeat suicide attempts in adolescents among the 3 service type treatment arms.
Time Frame
up to 12 months post-discharge
Title
Relation between service type and frequency of readmissions after a suicide attempt in adolescents.
Description
Comparing the frequency of readmissions after a suicide attempt in adolescents among the 3 service type treatment arms.
Time Frame
up to 12 months post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatiana Falcone, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12900312
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.
Results Reference
background
PubMed Identifier
12649626
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.
Results Reference
background
PubMed Identifier
23303463
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.
Results Reference
background
PubMed Identifier
25444653
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.
Results Reference
background
PubMed Identifier
17579545
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.
Results Reference
background
PubMed Identifier
12590618
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.
Results Reference
background

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