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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Anxiety Disorders, Suicide, Depressive Disorder, Major, Suicidal Ideation, Suicidal Impulses

Intervention / Treatment
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* Behavioral: Standard of Care
* Behavioral: Crisis Intervention
* Behavioral: Wraparound Services


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Treatment As Usual (E-TAU)<br>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. | Behavioral: Standard of Care<br>* Follow-Up Calls, Questionnaires<br>|
| Experimental: TAU + Crisis Center (CC) Follow Up<br>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. | Behavioral: Standard of Care<br>* Follow-Up Calls, Questionnaires<br>Behavioral: Crisis Intervention<br>* Frontline Services will be administering follow up phone calls for participants of the study, recently discharged from the emergency room.<br>|
| Experimental: TAU + CC Follow Up + Wraparound Services<br>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. | Behavioral: Standard of Care<br>* Follow-Up Calls, Questionnaires<br>Behavioral: Crisis Intervention<br>* Frontline Services will be administering follow up phone calls for participants of the study, recently discharged from the emergency room.<br>Behavioral: Wraparound Services<br>* Tapestry will be assigning case management services for participants randomized into the third arm of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suicide, Adolescent, Intervention, Crisis, Follow-Up