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| Name | Class |
|---|---|
| Case Western Reserve University | OTHER |
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This research study is designed to answer specific questions about new ways to provide services for youth at-risk of suicide.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enhanced Treatment As Usual (E-TAU) | Experimental | 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. |
|
| TAU + Crisis Center (CC) Follow Up | Experimental | 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. |
|
| TAU + CC Follow Up + Wraparound Services | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care | Behavioral | Follow-Up Calls, Questionnaires |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of repeat suicide attempts in adolescents. | Frequency of repeat suicide attempts during the 12 month follow up | up to 12 months post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of readmissions after a suicide attempt in adolescents. | Frequency of readmissions after a suicide attempt in adolescents | up to 12 months post-discharge |
| Relation between service type and frequency of repeat suicide attempts in adolescents. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tatiana Falcone, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Fairview Hospital | Cleveland | Ohio | 44111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12900312 | Background | 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. | |
| 12649626 | Background |
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|
| Crisis Intervention | Behavioral | Frontline Services will be administering follow up phone calls for participants of the study, recently discharged from the emergency room. |
|
| Wraparound Services | Behavioral | Tapestry will be assigning case management services for participants randomized into the third arm of the study. |
|
Comparing the frequency of repeat suicide attempts in adolescents among the 3 service type treatment arms. |
| up to 12 months post-discharge |
| 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. | up to 12 months post-discharge |
| 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. |
| 23303463 | Background | 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. |
| 25444653 | Background | 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. |
| 17579545 | Background | 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. |
| 12590618 | Background | 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. |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D003865 | Depressive Disorder, Major |
| D001008 | Anxiety Disorders |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D003419 | Crisis Intervention |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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