An interventional study of Cognitive Therapy for Suicide Prevention and Services as Usual in Suicide Prevention, sponsored by Ohio State University. Recruiting at 1 site in United States. Open to participants aged 15 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by Ohio State University · Not applicable, Interventional, and Prevention
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.
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.
190 studies on the registry are indexed under Suicide Prevention; 87 are open to participants now.
This study's planned enrollment of 300 is above the median of 150 across 169 interventional studies indexed under Suicide Prevention.
Browse Suicide Prevention studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Cognitive Therapy for Suicide Prevention · Behavioral: 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.
Behavioral: Services as Usual
10 sessions of cognitive therapy for suicide prevention plus 9 optional booster sessions
Also known as: CTSP
Participants will receive services that they would normally receive in the community.
Also known as: SAU
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.
Time frame: baseline, 3, 6, 9 and 12 months
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.
Time frame: 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.
Time frame: baseline, 3, 6, 9 and 12 months
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf
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