Suicide Prevention Among Substance Abusing Homeless Youth
Primary Purpose
Suicide
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Therapy for Suicide Prevention
Services as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Suicide
Eligibility Criteria
Inclusion Criteria:
- 18-24
- meet McKinney Vento definition for homelessness.
- Youth reports at least one episode of severe suicide ideation in the past 90 days.
Exclusion Criteria:
- Evidence of unremitted psychosis or other condition which would impair youth's ability to understand and participate in the research.
- Youth requires psychiatric hospitalization.
Sites / Locations
- The Ohio State University Department of Human Development and Family Science
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
CTSP + SAU
Services as Usual (SAU)
Arm Description
10 sessions of Cognitive Therapy for Suicide Prevention (CTSP) provided over 6 months, with optional 9 booster sessions + SAU
client receives services they would normally receive within the community
Outcomes
Primary Outcome Measures
change in suicide ideation
suicide ideation assessed at baseline, 3, 6 and 9 months post-baseline using self-report measures
Secondary Outcome Measures
Full Information
NCT ID
NCT02576834
First Posted
October 10, 2015
Last Updated
August 30, 2019
Sponsor
Ohio State University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT02576834
Brief Title
Suicide Prevention Among Substance Abusing Homeless Youth
Official Title
Suicide Prevention Among Substance Abusing Homeless Youth
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The literature is characterized by a dearth of information on interventions for homeless youth, and no suicide prevention intervention has been tested with these youth. Such focus is critical as suicide is the leading cause of death among homeless youth. Therefore, this study seeks to address this gap in the research literature with the goal to identify an effective strategy to intervene in suicide ideation in this population.
Detailed Description
While research on homeless youth is increasing, there is a dearth of information regarding effective interventions for these youth. This is of significant concern because studies indicate that 70-95% report problem alcohol or drug use and 66% to 89% of homeless youth have a mental health disorder. Suicide is the leading cause of death with up to 68% of youth reporting a lifetime suicide attempt. Among those who have attempted, an average of 6.2 attempts is reported. In addition, lifetime suicide ideation rates have ranged from 14% to 66.5%. Some predictors of suicide among homeless youth have been identified. These include substance use, childhood physical and sexual abuse, victimization experiences while living on the streets, and psychological functioning, including depression, hopelessness, distress tolerance, impulse control, social support, and problem solving. This study uses general cognitive theory, complemented with concepts from two suicide specific theoretical models, to guide our intervention and conceptual change model. Consonant with the pilot R34 announcement, this study's goal is to pilot test an intervention that has previously demonstrated feasibility and promise with adolescent suicide attempters and efficacy with a low-income sample of adults, "The Cognitive Therapy Intervention for Suicide Attempters." One-hundred fifty homeless youth with recent severe suicide ideation will be randomly assigned to the experimental cognitive therapy for suicide prevention (CTSP) + services as usual (SAU) (n=75) or to SAU alone (n=75). SAU includes those services normally offered through a local drop-in center. Follow-up assessments will be conducted at 3, 6, and 9-months post-baseline. It is hypothesized that youth receiving CTSP+SAU will show greater reductions in suicide ideation (primary outcome), substance use and depressive symptoms (secondary outcomes) over time compared to SAU alone. Furthermore, theoretically-derived mediators will be tested to shed light on mechanisms associated with change. The data from this study will be used to determine the initial efficacy of this promising intervention, and determine whether findings warrant a broader scale effectiveness trial. Ultimately, attention towards reducing suicide risk among these youth has the potential to reduce premature mortality, hospitalization and loss of human capital in a very high risk population of youth.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CTSP + SAU
Arm Type
Experimental
Arm Description
10 sessions of Cognitive Therapy for Suicide Prevention (CTSP) provided over 6 months, with optional 9 booster sessions + SAU
Arm Title
Services as Usual (SAU)
Arm Type
Other
Arm Description
client receives services they would normally receive within the community
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Therapy for Suicide Prevention
Other Intervention Name(s)
CTSP
Intervention Description
10 sessions of cognitive therapy for suicide prevention provided, along with optional 9 booster sessions + SAU
Intervention Type
Other
Intervention Name(s)
Services as Usual
Other Intervention Name(s)
SAU
Intervention Description
Services as usually provided in the community
Primary Outcome Measure Information:
Title
change in suicide ideation
Description
suicide ideation assessed at baseline, 3, 6 and 9 months post-baseline using self-report measures
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18-24
meet McKinney Vento definition for homelessness.
Youth reports at least one episode of severe suicide ideation in the past 90 days.
Exclusion Criteria:
Evidence of unremitted psychosis or other condition which would impair youth's ability to understand and participate in the research.
Youth requires psychiatric hospitalization.
Facility Information:
Facility Name
The Ohio State University Department of Human Development and Family Science
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Suicide Prevention Among Substance Abusing Homeless Youth
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