Clinical Trials Directory

Trials / Completed

CompletedNCT03016572

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
65 (actual)
Sponsor
The Cleveland Clinic · Academic / Other
Sex
All
Age
10 Years – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALStandard of CareFollow-Up Calls, Questionnaires
BEHAVIORALCrisis InterventionFrontline Services will be administering follow up phone calls for participants of the study, recently discharged from the emergency room.
BEHAVIORALWraparound ServicesTapestry will be assigning case management services for participants randomized into the third arm of the study.

Timeline

Start date
2017-05-04
Primary completion
2021-08-31
Completion
2021-08-31
First posted
2017-01-10
Last updated
2021-09-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03016572. Inclusion in this directory is not an endorsement.