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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03016572
Recruitment Status : Active, not recruiting
First Posted : January 10, 2017
Last Update Posted : October 6, 2020
Sponsor:
Collaborator:
Case Western Reserve University
Information provided by (Responsible Party):
Tatiana Falcone, MD, The Cleveland Clinic

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

Condition or disease Intervention/treatment Phase
Suicide Depressive Disorder, Major Anxiety Disorders Suicidal Ideation Suicidal Impulses Behavioral: Standard of Care Behavioral: Crisis Intervention Behavioral: Wraparound Services Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 4, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Enhanced Treatment As Usual (E-TAU)
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
Follow-Up Calls, Questionnaires

Experimental: TAU + Crisis Center (CC) Follow Up
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
Follow-Up Calls, Questionnaires

Behavioral: Crisis Intervention
Frontline Services will be administering follow up phone calls for participants of the study, recently discharged from the emergency room.

Experimental: TAU + CC Follow Up + Wraparound Services
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
Follow-Up Calls, Questionnaires

Behavioral: Crisis Intervention
Frontline Services will be administering follow up phone calls for participants of the study, recently discharged from the emergency room.

Behavioral: Wraparound Services
Tapestry will be assigning case management services for participants randomized into the third arm of the study.




Primary Outcome Measures :
  1. Frequency of repeat suicide attempts in adolescents. [ Time Frame: up to 12 months post-discharge ]
    Frequency of repeat suicide attempts during the 12 month follow up


Secondary Outcome Measures :
  1. Frequency of readmissions after a suicide attempt in adolescents. [ Time Frame: up to 12 months post-discharge ]
    Frequency of readmissions after a suicide attempt in adolescents

  2. Relation between service type and frequency of repeat suicide attempts in adolescents. [ Time Frame: up to 12 months post-discharge ]
    Comparing the frequency of repeat suicide attempts in adolescents among the 3 service type treatment arms.

  3. Relation between service type and frequency of readmissions after a suicide attempt in adolescents. [ Time Frame: up to 12 months post-discharge ]
    Comparing the frequency of readmissions after a suicide attempt in adolescents among the 3 service type treatment arms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016572


Locations
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United States, Ohio
Cleveland Clinic Fairview Hospital
Cleveland, Ohio, United States, 44111
Sponsors and Collaborators
The Cleveland Clinic
Case Western Reserve University
Investigators
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Principal Investigator: Tatiana Falcone, MD The Cleveland Clinic
Publications:
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Responsible Party: Tatiana Falcone, MD, Tatiana Falcone M.D., The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03016572    
Other Study ID Numbers: 16-886
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tatiana Falcone, MD, The Cleveland Clinic:
Suicide
Adolescent
Intervention
Crisis
Follow-Up
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Anxiety Disorders
Suicide
Suicidal Ideation
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Self-Injurious Behavior