- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02576834
Suicide Prevention Among Substance Abusing Homeless Youth
August 30, 2019 updated by: Natasha Slesnick, Ohio State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- The Ohio State University Department of Human Development and Family Science
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 24 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CTSP + SAU
10 sessions of Cognitive Therapy for Suicide Prevention (CTSP) provided over 6 months, with optional 9 booster sessions + SAU
|
10 sessions of cognitive therapy for suicide prevention provided, along with optional 9 booster sessions + SAU
Other Names:
Services as usually provided in the community
Other Names:
|
Other: Services as Usual (SAU)
client receives services they would normally receive within the community
|
Services as usually provided in the community
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in suicide ideation
Time Frame: 9 months
|
suicide ideation assessed at baseline, 3, 6 and 9 months post-baseline using self-report measures
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2015
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
September 1, 2018
Study Registration Dates
First Submitted
October 10, 2015
First Submitted That Met QC Criteria
October 14, 2015
First Posted (Estimate)
October 15, 2015
Study Record Updates
Last Update Posted (Actual)
September 3, 2019
Last Update Submitted That Met QC Criteria
August 30, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014B0532
- R34DA037845 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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