Cleveland Clinic Fairview Hospital
Cleveland, Ohio, 44111, United States
NCT Number: NCT03016572
This research study is designed to answer specific questions about new ways to provide services for youth at-risk of suicide.
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Notify Me10 year–18 year
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44111, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Follow-Up Calls, Questionnaires
Frontline Services will be administering follow up phone calls for participants of the study, recently discharged from the emergency room.
Tapestry will be assigning case management services for participants randomized into the third arm of the study.
Time frame: up to 12 months post-discharge
Frequency of repeat suicide attempts during the 12 month follow up
Time frame: up to 12 months post-discharge
Frequency of readmissions after a suicide attempt 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.
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.
The Cleveland Clinic
Other
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
Acronym: PASS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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