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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
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide Prevention

Eligibility Criteria

15 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 8, 2023
    Last Updated
    August 15, 2023
    Sponsor
    Ohio State University
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    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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