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

NCT03016572 | Completed DMC

• 1 other identifier: 16-886
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Suicide; Adolescent; Intervention; Crisis; Follow-Up

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

  up to 12 months post-discharge

• Relation between service type and frequency of readmissions after a suicide attempt in adolescents.

  up to 12 months post-discharge

Study Arms (3)

Enhanced Treatment As Usual (E-TAU)

EXPERIMENTAL

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

TAU + Crisis Center (CC) Follow Up

EXPERIMENTAL

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; Behavioral: Crisis Intervention

TAU + CC Follow Up + Wraparound Services

EXPERIMENTAL

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; Behavioral: Crisis Intervention; Behavioral: Wraparound Services

Interventions

Standard of Care BEHAVIORAL

Follow-Up Calls, Questionnaires

Enhanced Treatment As Usual (E-TAU); TAU + CC Follow Up + Wraparound Services; TAU + Crisis Center (CC) Follow Up

Crisis Intervention BEHAVIORAL

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

TAU + CC Follow Up + Wraparound Services; TAU + Crisis Center (CC) Follow Up

Wraparound Services BEHAVIORAL

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

TAU + CC Follow Up + Wraparound Services

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Case Western Reserve University: collaborator

Study Sites (1)

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Related Publications (6)

• Brent DA, Oquendo M, Birmaher B, Greenhill L, Kolko D, Stanley B, Zelazny J, Brodsky B, Firinciogullari S, Ellis SP, Mann JJ. Peripubertal suicide attempts in offspring of suicide attempters with siblings concordant for suicidal behavior. Am J Psychiatry. 2003 Aug;160(8):1486-93. doi: 10.1176/appi.ajp.160.8.1486.

  PMID: 12900312 BACKGROUND

• Gould MS, Greenberg T, Velting DM, Shaffer D. Youth suicide risk and preventive interventions: a review of the past 10 years. J Am Acad Child Adolesc Psychiatry. 2003 Apr;42(4):386-405. doi: 10.1097/01.CHI.0000046821.95464.CF.

  PMID: 12649626 BACKGROUND

• Nock MK, Green JG, Hwang I, McLaughlin KA, Sampson NA, Zaslavsky AM, Kessler RC. Prevalence, correlates, and treatment of lifetime suicidal behavior among adolescents: results from the National Comorbidity Survey Replication Adolescent Supplement. JAMA Psychiatry. 2013 Mar;70(3):300-10. doi: 10.1001/2013.jamapsychiatry.55.

  PMID: 23303463 BACKGROUND

• Torio CM, Encinosa W, Berdahl T, McCormick MC, Simpson LA. Annual report on health care for children and youth in the United States: national estimates of cost, utilization and expenditures for children with mental health conditions. Acad Pediatr. 2015 Jan-Feb;15(1):19-35. doi: 10.1016/j.acap.2014.07.007. Epub 2014 Nov 13.

  PMID: 25444653 BACKGROUND

• Gould MS, Kalafat J, Harrismunfakh JL, Kleinman M. An evaluation of crisis hotline outcomes. Part 2: Suicidal callers. Suicide Life Threat Behav. 2007 Jun;37(3):338-52. doi: 10.1521/suli.2007.37.3.338.

  PMID: 17579545 BACKGROUND

• Busch KA, Fawcett J, Jacobs DG. Clinical correlates of inpatient suicide. J Clin Psychiatry. 2003 Jan;64(1):14-9. doi: 10.4088/jcp.v64n0105.

  PMID: 12590618 BACKGROUND

MeSH Terms

Conditions

Suicide; Depressive Disorder, Major; Anxiety Disorders; Suicidal Ideation

Interventions

Standard of Care; Crisis Intervention

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Tatiana Falcone, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tatiana Falcone M.D.

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 10, 2017
• Study Start: May 4, 2017
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)