Suicide Prevention for Substance Using Youth Experiencing Homelessness
Primary Purpose
Suicide Prevention
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Therapy for Suicide Prevention
Services as Usual
Sponsored by
About this trial
This is an interventional prevention trial for Suicide Prevention
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive Therapy for Suicide Prevention + Services as Usual
Services as Usual
Arm Description
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.
Services as Usual involves utilizing Strengths-Based Outreach and Advocacy to link youth to community services for a period of 6 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05994612
Brief Title
Suicide Prevention for Substance Using Youth Experiencing Homelessness
Official Title
Suicide Prevention for Substance Using Youth Experiencing Homelessness
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
June 30, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive Therapy for Suicide Prevention + Services as Usual
Arm Type
Experimental
Arm Description
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.
Arm Title
Services as Usual
Arm Type
Active Comparator
Arm Description
Services as Usual involves utilizing Strengths-Based Outreach and Advocacy to link youth to community services for a period of 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Therapy for Suicide Prevention
Other Intervention Name(s)
CTSP
Intervention Description
10 sessions of cognitive therapy for suicide prevention plus 9 optional booster sessions
Intervention Type
Behavioral
Intervention Name(s)
Services as Usual
Other Intervention Name(s)
SAU
Intervention Description
Participants will receive services that they would normally receive in the community.
Primary Outcome Measure Information:
Title
Suicidal Ideation: Scale for Suicidal Ideation-Worst Point (SSI-W)
Description
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
Secondary Outcome Measure Information:
Title
Depressive Symptoms: Beck Depression Inventory II
Description
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
Title
Substance use: Form 90
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natasha Slesnick, PhD
Phone
6142478469
Email
slesnick.5@osu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natasha Slesnick
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Suicide Prevention for Substance Using Youth Experiencing Homelessness
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