- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05994612
Suicide Prevention for Substance Using Youth Experiencing Homelessness
April 15, 2026 updated by: Ohio State University
Suicide is the leading cause of death among YEH and most youth do not access services that may be available to them.
Therefore, this study seeks to address this gap in the research literature with the goal to identify an effective intervention that can be readily adopted by communities that serve these youth.
We will test the effects of outreach-worker delivered Cognitive Therapy for Suicide Prevention (CTSP)+Services as Usual (SAU) versus SAU alone on suicidal ideation (primary outcome), substance use and depressive symptoms (secondary outcomes) at 3, 6, 9 and 12- months.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
While research on substance using youth experiencing homelessness (YEH) is increasing, there is a dearth of information regarding effective prevention interventions for these youth.
This is of significant concern because studies indicate that 66% to 89% of YEH have a mental health disorder and 68% report at least one suicide attempt .
In fact, suicide is the leading cause of death among YEH.
Among those who have attempted suicide, an average of 6.2 attempts is reported, and lifetime suicidal ideation rates range from 14% to 66.5% with no clear evidence of effective interventions for YEH.
This study uses general cognitive theory, complemented with concepts from two suicide specific theoretical models, to guide our intervention and conceptual change model.
The study goal is to test strategies to extend delivery and uptake of a cognitive therapy intervention for YEH.
Prior studies focus on service-connected youth, but research suggests that most street living YEH do not access services meant to assist them.
Prior sampling limitations are overcome through engaging service-disconnected youth in addition to service-connected youth through a local drop-in center.
As such, three hundred substance using YEH with recent suicidal ideation or a recent suicide attempt will be randomly assigned to Cognitive Therapy for Suicide Prevention (CTSP) + Services as Usual (SAU) (N=150) or to SAU alone (N=150).
CTSP has previously shown efficacy for YEH through a RCT pilot feasibility study.
SAU includes outreach, advocacy and service linkage which are typical services offered by agencies serving those experiencing homelessness.
Follow-up assessments will be conducted at 3, 6, 9 and 12-months post-baseline.
It is hypothesized that youth receiving CTSP+SAU will show greater reductions in suicidal ideation (primary outcome), substance use and depressive symptoms (secondary outcomes) over time compared to SAU alone, as well as improved risk and protective factors.
Theoretically-derived mediators will be tested to shed light on mechanisms associated with change, and the moderating effects of sex, race, sexual orientation and baseline service connection will be examined.
In order to ease future dissemination of the intervention to agencies serving YEH, the investigators will rigorously assess acceptability, feasibility, fidelity and cost associated with the delivery of our intervention approach using a mixed-methods approach.
Ultimately, the goal of this research is to provide support for the use of a suicide prevention intervention for substance using YEH that reduces premature mortality, hospitalization, and loss of human capital and which can be easily adopted by agencies serving YEH.
Study Type
Interventional
Enrollment (Estimated)
300
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 Contact
- Name: Natasha Slesnick, PhD
- Phone Number: 6142478469
- Email: slesnick.5@osu.edu
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Recruiting
- The Ohio State University
-
Contact:
- Natasha Slesnick, Ph.D.
- Phone Number: 614-247-8469
- Email: slesnick.5@osu.edu
-
Principal Investigator:
- Natasha Slesnick, Ph.D.
-
-
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
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 15-24 years
- SSI-W score > 4 or at least one suicide attempt in prior 12 months
- Meets criteria for homelessness
- At least four uses of alcohol/drugs in prior 30 days
Exclusion Criteria:
- 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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Cognitive Therapy for Suicide Prevention + Services as Usual
10 sessions of Cognitive Therapy for Suicide Prevention (CTSP) provided over 6 months, with 9 optional booster sessions + services as usual (SAU) received by the community.
|
10 sessions of cognitive therapy for suicide prevention plus 9 optional booster sessions
Other Names:
Participants will receive services that they would normally receive in the community.
Other Names:
|
|
Active Comparator: Services as Usual
Services as Usual involves utilizing Strengths-Based Outreach and Advocacy to link youth to community services for a period of 6 months.
|
Participants will receive services that they would normally receive in the community.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suicidal Ideation: Scale for Suicidal Ideation-Worst Point (SSI-W)
Time Frame: baseline, 3, 6, 9 and 12 months
|
Change in suicidal ideation is measured using the Scale for Suicidal Ideation-Worst Point (SSI-W).
Each item consists of three options, which are rated on a 3-point scale from 0 to 2, and each item is graded according to the intensity of the suicidality.
Total scores are calculated by summing the 19 ratings, and these total scores can range from 0 to 38 with higher scores indicating worse severity.
|
baseline, 3, 6, 9 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive Symptoms: Beck Depression Inventory II
Time Frame: baseline, 3, 6, 9 and 12 months
|
The Beck Depression Inventory II is a 21-item inventory that assesses the severity of depressive symptomatology.
Each item is rated on a 0-3 scale with summary scores ranging between 0 and 63 and higher scores indicating higher depressive symptomatology.
|
baseline, 3, 6, 9 and 12 months
|
|
Substance use: Form 90
Time Frame: baseline, 3, 6, 9 and 12 months
|
Frequency of substance use is measured using the Form-90, a semi-structured questionnaire that uses the timeline follow-back method.
Form yields percentage of days in the prior 90 days using alcohol and drugs.
|
baseline, 3, 6, 9 and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Natasha Slesnick, Ohio State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
November 20, 2023
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
January 1, 2030
Study Registration Dates
First Submitted
August 8, 2023
First Submitted That Met QC Criteria
August 8, 2023
First Posted (Actual)
August 16, 2023
Study Record Updates
Last Update Posted (Actual)
April 16, 2026
Last Update Submitted That Met QC Criteria
April 15, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023B0145
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
We will share results from surveys after de-identification through the Inter-University Consortium for Political and Social Research (ICPSR), an NIH funded data repository, within one year of completion of data collection (see https://www.icpsr.umich.edu/icpsrweb/).
Submitted data will conform with relevant data and terminology standards.
IPD Sharing Time Frame
one year after project close-out.
IPD Sharing Access Criteria
Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) for secondary study/data analysis purposes and with study PI approval.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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