Suicide Prevention for Substance Using Youth Experiencing Homelessness
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ClinicalTrials.gov Identifier: NCT05994612 |
Recruitment Status :
Recruiting
First Posted : August 16, 2023
Last Update Posted : April 2, 2024
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Condition or disease | Intervention/treatment | Phase |
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Suicide Prevention | Behavioral: Cognitive Therapy for Suicide Prevention Behavioral: Services as Usual | Not Applicable |
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 |
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.
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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.
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Behavioral: Services as Usual
Participants will receive services that they would normally receive in the community.
Other Name: SAU |
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 15 Years to 24 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
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
Contact: Natasha Slesnick, PhD | 6142478469 | slesnick.5@osu.edu |
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. |
Principal Investigator: | Natasha Slesnick | Ohio State University |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Suicide Suicide Prevention Self-Injurious Behavior Behavioral Symptoms |