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Suicide Prevention for Substance Using Youth Experiencing Homelessness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05994612
Recruitment Status : Recruiting
First Posted : August 16, 2023
Last Update Posted : April 2, 2024
Sponsor:
Information provided by (Responsible Party):
Ohio State University

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Suicide Prevention Behavioral: Cognitive Therapy for Suicide Prevention Behavioral: Services as Usual Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Suicide Prevention for Substance Using Youth Experiencing Homelessness
Actual Study Start Date : November 1, 2023
Estimated Primary Completion Date : January 1, 2029
Estimated Study Completion Date : June 30, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arms and Interventions
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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.
 Behavioral: Cognitive Therapy for Suicide Prevention
10 sessions of cognitive therapy for suicide prevention plus 9 optional booster sessions
Other Name: CTSP

Behavioral: Services as Usual
Participants will receive services that they would normally receive in the community.
Other Name: SAU
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.
 Behavioral: Services as Usual
Participants will receive services that they would normally receive in the community.
Other Name: SAU


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05994612


Contacts
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Contact: Natasha Slesnick, PhD 6142478469 slesnick.5@osu.edu

Locations
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United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Natasha Slesnick, Ph.D.    614-247-8469    slesnick.5@osu.edu   
Principal Investigator: Natasha Slesnick, Ph.D.         
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Natasha Slesnick Ohio State University
More Information
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Responsible Party: Ohio State University
ClinicalTrials.gov Identifier: NCT05994612    
Other Study ID Numbers: 2023B0145
First Posted: August 16, 2023    Key Record Dates
Last Update Posted: April 2, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: one year after project close-out.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Suicide
Suicide Prevention
Self-Injurious Behavior
Behavioral Symptoms