Systems Aligning for Equity (SAFE) Spaces (SAFE Spaces)
Primary Purpose
Suicide, Mental Disorder, Mental Health
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SAFE Spaces training and coaching
Sponsored by
About this trial
This is an interventional prevention trial for Suicide
Eligibility Criteria
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.
Sites / Locations
- New York UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SAFE Spaces training and coaching
Training as Usual
Arm Description
Staff in facilities assigned to this arm are offered the SAFE Spaces training and coaching model.
Staff in facilities assigned to this arm receive training as usual.
Outcomes
Primary Outcome Measures
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
Decreases on Self-Injurious Thoughts and Behaviors Interview (Nock et al., 2007)
Change in self-harm thoughts and behaviors
Decreases on internalizing and externalizing subscales of Massachusetts Youth Screening Instrument (Grisso et al., 2001)
Change in mental health correlates of suicide
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
Change in responses on the Inventory of Depression and Anxiety Symptoms (Watson et al., 2007)
Change in staff mental health
Increased suicide knowledge and response skills from Tennessee's state-wide gatekeeper training (Schut & Lockman, 2013)
Change in suicide knowledge and response skills
Increased self-harm knowledge response skills from Tennessee's state-wide gatekeeper training (Schut & Lockman, 2013)
Change in self-harm knowledge and response skills
Secondary Outcome Measures
Full Information
NCT ID
NCT05658068
First Posted
December 1, 2022
Last Updated
December 19, 2022
Sponsor
New York University
1. Study Identification
Unique Protocol Identification Number
NCT05658068
Brief Title
Systems Aligning for Equity (SAFE) Spaces
Acronym
SAFE Spaces
Official Title
Experimental Evaluation of a Multi-site Suicide Intervention for Youth During and After Residential Placement
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 23, 2022 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Mental Disorder, Mental Health, Burnout, Professional, Self Harm
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SAFE Spaces training and coaching
Arm Type
Experimental
Arm Description
Staff in facilities assigned to this arm are offered the SAFE Spaces training and coaching model.
Arm Title
Training as Usual
Arm Type
No Intervention
Arm Description
Staff in facilities assigned to this arm receive training as usual.
Intervention Type
Behavioral
Intervention Name(s)
SAFE Spaces training and coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decreases in Suicidal Ideation Questionnaire (Davis, 1992) and suicide subscale of Massachusetts Youth Screening Instrument (Grisso et al., 2001)
Description
Change in suicide ideation, thoughts, and behaviors
Time Frame
1 year
Title
Decreases on Self-Injurious Thoughts and Behaviors Interview (Nock et al., 2007)
Description
Change in self-harm thoughts and behaviors
Time Frame
1 year
Title
Decreases on internalizing and externalizing subscales of Massachusetts Youth Screening Instrument (Grisso et al., 2001)
Description
Change in mental health correlates of suicide
Time Frame
1 year
Title
Decreased burnout and increased job efficacy on the Professional Quality of Life measure (Stramm, 2016) and the Maslach Burnout Inventory
Description
Change in staff burnout and job efficacy
Time Frame
1 year
Title
Change in responses on the Inventory of Depression and Anxiety Symptoms (Watson et al., 2007)
Description
Change in staff mental health
Time Frame
1 year
Title
Increased suicide knowledge and response skills from Tennessee's state-wide gatekeeper training (Schut & Lockman, 2013)
Description
Change in suicide knowledge and response skills
Time Frame
1 year
Title
Increased self-harm knowledge response skills from Tennessee's state-wide gatekeeper training (Schut & Lockman, 2013)
Description
Change in self-harm knowledge and response skills
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shabnam Javdani, PhD
Phone
(212) 992-9739
Email
shabnam.javdani@nyu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Godfrey, PhD
Phone
(212) 998-5379
Email
erin.godfrey@nyu.edu
Facility Information:
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shabnam Javdani, PhD
Phone
212-992-9739
Email
shabnam.javdani@nyu.edu
First Name & Middle Initial & Last Name & Degree
Erin Godfrey, PhD
Phone
(212) 998-5396
Email
erin.godfrey@nyu.edu
12. IPD Sharing Statement
Learn more about this trial
Systems Aligning for Equity (SAFE) Spaces
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