Suicide PreventionNCT05994612
Suicide Prevention for Substance Using Youth Experiencing Homelessness
A study testing Cognitive Therapy for Suicide Prevention and Services as Usual in people with Suicide Prevention, run by Ohio State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide Prevention
- What is being tested?
- Cognitive Therapy for Suicide Prevention and Services as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2023to 1 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Youth requires psychiatric hospitalization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Natasha Slesnick, Ph.D., 614-247-8469, slesnick.5@osu.edu
Natasha Slesnick, Ph.D.
About this study
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.
Read the 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.
- Conditions
- Suicide Prevention
- Being tested
- Cognitive Therapy for Suicide Prevention, Services as Usual
- Medical subject headings
- Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Therapy for Suicide PreventionBehavioural
Also called CTSP
10 sessions of cognitive therapy for suicide prevention plus 9 optional booster sessions
Services as UsualBehavioural
Also called SAU
Participants will receive services that they would normally receive in the community.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Therapy for Suicide Prevention + Services as Usual | Experimental | 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. Receives: Behavioral: Cognitive Therapy for Suicide Prevention; Behavioral: Services as Usual |
| Services as Usual | Active comparator | Services as Usual involves utilizing Strengths-Based Outreach and Advocacy to link youth to community services for a period of 6 months. Receives: Behavioral: Services as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal Ideation: Scale for Suicidal Ideation-Worst Point (SSI-W)
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.
Measured: baseline, 3, 6, 9 and 12 months
Secondary outcomes (2)
Depressive Symptoms: Beck Depression Inventory II
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.
Measured: baseline, 3, 6, 9 and 12 months
Substance use: Form 90
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.
Measured: baseline, 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start20 Nov 2023
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Natasha Slesnick, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994612
- Sponsor's protocol ID
- 2023B0145
- Status last verified
- Apr 2026
- First submitted
- 8 Aug 2023
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Slesnick N, Brakenhoff B, Chavez LJ, Cuthbertson CL, Famelia R, Feng X, Ford J, Holowacz E, Jaderlund S, Kelleher K, Luthy E, Mallory AM, Pizzulo A, Slesnick TD, Yilmazer T. Suicide prevention for substance using youth experiencing homelessness: study protocol for a randomized controlled trial. Trials. 2024 Mar 9;25(1):174. doi: 10.1186/s13063-024-07997-y.
PubMed 38461275
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suicide Prevention for Substance Using Youth Experiencing Homelessness
- ClinicalTrials.gov ID
- NCT05994612
- Acronym / sponsor ID
- 2023B0145
- Conditions
- Suicide Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Therapy for Suicide Prevention + Services as Usual | Experimental | Behavioral: Cognitive Therapy for Suicide Prevention, Behavioral: Services as Usual10 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. |
| Services as Usual | Active comparator | Behavioral: Services as UsualServices as Usual involves utilizing Strengths-Based Outreach and Advocacy to link youth to community services for a period of 6 months. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Youth requires psychiatric hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Therapy for Suicide PreventionAlso: CTSP10 sessions of cognitive therapy for suicide prevention plus 9 optional booster sessions | Behavioural | Cognitive Therapy for Suicide Prevention + Services as Usual |
| Services as UsualAlso: SAUParticipants will receive services that they would normally receive in the community. | Behavioural | Cognitive Therapy for Suicide Prevention + Services as Usual, Services as Usual |
Primary outcome
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.
2 secondary outcomes
Depressive Symptoms: Beck Depression Inventory II
Time frame: baseline, 3, 6, 9 and 12 months
Substance use: Form 90
Time frame: baseline, 3, 6, 9 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Derived from this study: PubMed 38461275Slesnick N, Brakenhoff B, Chavez LJ, Cuthbertson CL, Famelia R, Feng X, Ford J, Holowacz E, Jaderlund S, Kelleher K, Luthy E, Mallory AM, Pizzulo A, Slesnick TD, Yilmazer T. Suicide prevention for substance using youth experiencing homelessness: study protocol for a randomized controlled trial. Trials. 2024 Mar 9;25(1):174. doi: 10.1186/s13063-024-07997-y.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Natasha Slesnick principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Therapy for Suicide Prevention and Services as Usual in people with Suicide Prevention, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natasha Slesnick, PhD (6142478469, slesnick.5@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidal Ideation: Scale for Suicidal Ideation-Worst Point (SSI-W) (time frame: baseline, 3, 6, 9 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05994612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.