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Completed

NCT Number: NCT03016572

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

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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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, 44111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard of Care

Behavioral

Follow-Up Calls, Questionnaires

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

  • Case Western Reserve University

Registry information

Official study 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

Acronym: PASS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 10, 2017
Registry last updated
Sep 14, 2021

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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