NCT05994612

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Nov 2023Jan 2030

First Submitted

Initial submission to the registry

August 8, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

November 20, 2023

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

5.1 years

First QC Date

August 8, 2023

Last Update Submit

April 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline, 3, 6, 9 and 12 months

Secondary Outcomes (2)

  • Depressive Symptoms: Beck Depression Inventory II

    baseline, 3, 6, 9 and 12 months

  • Substance use: Form 90

    baseline, 3, 6, 9 and 12 months

Study Arms (2)

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.

Behavioral: Cognitive Therapy for Suicide PreventionBehavioral: 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.

Behavioral: Services as Usual

Interventions

10 sessions of cognitive therapy for suicide prevention plus 9 optional booster sessions

Also known as: CTSP
Cognitive Therapy for Suicide Prevention + Services as Usual

Participants will receive services that they would normally receive in the community.

Also known as: SAU
Cognitive Therapy for Suicide Prevention + Services as UsualServices as Usual

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Youth requires psychiatric hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Suicide Prevention

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Natasha Slesnick

    Ohio State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasha Slesnick, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2023

First Posted

August 16, 2023

Study Start

November 20, 2023

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2030

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, 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.

Locations