Improving Care Provided to Patients Treated in a Level 1 Trauma Center Post-suicide Attempt

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Washington.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT01355848
First received: May 10, 2011
Last updated: May 24, 2011
Last verified: May 2011
  Purpose

The aim of the study is to refine, elaborate, and pilot a brief intervention for patients between 15-24 years of age following a suicide attempt provided during hospitalization in an acute medical setting. 40 participants will be randomized to receive the brief intervention + care as usual or only care as usual. It is hypothesized that the intervention will be acceptable and feasible to both patients and intervention clinicians.


Condition Intervention Phase
Suicidal Ideas
Behavioral: Brief Intervention for Suicidality
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Care Provided to Patients Treated in a Level 1 Trauma Center Post-suicide Attempt

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Patient Satisfaction Questionnaire [ Time Frame: (baseline) Assessment taking place immediately after completion of intervention ] [ Designated as safety issue: No ]
    The Patient Satisfaction Questionnaire will be used to determine the acceptability of the intervention by the patient.


Secondary Outcome Measures:
  • Scale for Suicide Ideation [ Time Frame: One month follow-up assessment ] [ Designated as safety issue: Yes ]
    The Scale for Suicide Ideation will be used to determine the severity of current suicidality in all participants at the one-month follow-up as compared to the baseline assessment.


Estimated Enrollment: 40
Study Start Date: May 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brief Intervention
The brief intervention consists of stepped care protocol, including building rapport, functional analysis of suicidal behavior, and crisis planning
Behavioral: Brief Intervention for Suicidality
Focuses on behavioral elements of care, including building rapport, functional analysis, and crisis planning
No Intervention: care as usual
Patients randomized to the care as usual arm will not receive the brief intervention.

Detailed Description:

The aim of the study is to refine, elaborate, and pilot a brief intervention for patients between 15-24 years of age following a suicide attempt provided during hospitalization in an acute medical setting, and will be addressed with a sample of cases (N = 40) from Harborview. The participants will be randomized into one of two groups: those that receive the intervention and those that do not. All participants will complete a battery of assessments The intervention is based on the theory of teachable moments, wherein timing in proximity to injury and appropriate treatment setting provide a unique opportunity to create patient behavioral change. The brief intervention consists of engaging the patient in conversation regarding suicidal ambivalence (desire to live vs. desire to die), collaborative discovery of primary and secondary drivers of suicidality, and safety planning. A guide to delivering the intervention has been completed and may undergo changes throughout the study. Adherence measures will be developed in order to assess the degree to which the clinician accurately provided the brief intervention without including additional therapeutic elements or leaving out elements required in the intervention guide. Best methods for integrating the brief intervention into services provided on medical and surgical units will be determined, as well.

  Eligibility

Ages Eligible for Study:   15 Years to 24 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 15-24 years of age
  • Inpatient on medical/surgical unit
  • Admitted following a suicide attempt
  • Sufficient English to benefit from psychotherapy in English
  • Consents to be a research participant

Exclusion Criteria:

  • Lack of sufficient English to participate in psychotherapy in English
  • Prisoner/inmate at time of admission
  • Too cognitively impaired, delirious, or psychotic to respond to psychotherapeutic intervention before end of stay on medical/surgical unit. Determination of cognitive impairment, delirium, agitation, and psychosis will be determined through the referral phone call between the PI and the referring care provider, as well as the PI's own clinical assessment of the patient at the outset of the brief intervention.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01355848

Contacts
Contact: Stephen O'Connor, PhD 206-595-8615 oconnor7@uw.edu

Locations
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Richard Goss, MD, MPH    206-744-3134    meddirec@uw.edu   
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Stephen O'Connor, PhD University of Washington
  More Information

No publications provided

Responsible Party: Stephen O'Connor, University of Washington
ClinicalTrials.gov Identifier: NCT01355848     History of Changes
Other Study ID Numbers: 39417-C, T32HS013835_1
Study First Received: May 10, 2011
Last Updated: May 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Suicide
Brief Intervention
Youth
Acute Medical Setting
Readiness to Change
Suicidality

Additional relevant MeSH terms:
Suicide
Suicide, Attempted
Behavioral Symptoms
Self-Injurious Behavior

ClinicalTrials.gov processed this record on October 23, 2014