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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05658068
Other study ID # IRB-FY2019-3228
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 23, 2022
Est. completion date May 31, 2025

Study information

Verified date January 2024
Source New York University
Contact Shabnam Javdani, PhD
Phone (212) 992-9739
Email shabnam.javdani@nyu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this 2-arm cluster randomized clinical trial is to test whether an evidence-based staff training and coaching model specifically designed as a response to legal system-involved youths' and frontline staff's mental health needs can improve the safety and suicide outcomes, mental health challenges, and wellness and facility climate for youth and staff in facilities assigned to the intervention condition. Staff in facilities assigned to the intervention are eligible to receive evidence-based programming in suicide detection and prevention (Shield of Care; SOC) and wellness skill-building (Skills for Life) through training and personalized coaching. Multiple training sessions will be offered to small groups of staff in-person in residential facilities and paired with personalized in-person and virtual coaching. Staff and youth in all facilities will be asked to complete periodic surveys assessing experiences in the facility, suicide and safety knowledge and risk, and their mental health and wellness. Researchers will compare outcomes of staff in youth in facilities assigned to the intervention compared to facilities in the training-as-usual condition.


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date May 31, 2025
Est. primary completion date August 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Placement in in ACS-run or contracted residential facilities enrolled in the study during the first 2 years of the intervention period - Proficiency in English Exclusion Criteria: - Not placed in an ACS run-or contracted facility enrolled in the study during the study period - Lack of proficiency in English.

Study Design


Intervention

Behavioral:
SAFE Spaces training and coaching
Staff in facilities assigned to the intervention are eligible to receive evidence-based programming in suicide detection and prevention (Shield of Care; SOC) and wellness skill-building (Skills for Life) through training and personalized coaching. Multiple training sessions will be offered to small groups of staff in-person in residential facilities and paired with personalized in-person and virtual coaching.

Locations

Country Name City State
United States New York University New York New York

Sponsors (1)

Lead Sponsor Collaborator
New York University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Decreases in Suicidal Ideation Questionnaire (Davis, 1992) and suicide subscale of Massachusetts Youth Screening Instrument (Grisso et al., 2001) Change in suicide ideation, thoughts, and behaviors 1 year
Primary Decreases on Self-Injurious Thoughts and Behaviors Interview (Nock et al., 2007) Change in self-harm thoughts and behaviors 1 year
Primary Decreases on internalizing and externalizing subscales of Massachusetts Youth Screening Instrument (Grisso et al., 2001) Change in mental health correlates of suicide 1 year
Primary Decreased burnout and increased job efficacy on the Professional Quality of Life measure (Stramm, 2016) and the Maslach Burnout Inventory Change in staff burnout and job efficacy 1 year
Primary Change in responses on the Inventory of Depression and Anxiety Symptoms (Watson et al., 2007) Change in staff mental health 1 year
Primary Increased suicide knowledge and response skills from Tennessee's state-wide gatekeeper training (Schut & Lockman, 2013) Change in suicide knowledge and response skills 1 year
Primary Increased self-harm knowledge response skills from Tennessee's state-wide gatekeeper training (Schut & Lockman, 2013) Change in self-harm knowledge and response skills 1 year
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