- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05658068
Systems Aligning for Equity (SAFE) Spaces (SAFE Spaces)
March 21, 2024 updated by: New York University
Experimental Evaluation of a Multi-site Suicide Intervention for Youth During and After Residential Placement
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
800
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shabnam Javdani, PhD
- Phone Number: (212) 992-9739
- Email: shabnam.javdani@nyu.edu
Study Contact Backup
- Name: Erin Godfrey, PhD
- Phone Number: (212) 998-5379
- Email: erin.godfrey@nyu.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10003
- Recruiting
- New York University
-
Contact:
- Shabnam Javdani, PhD
- Phone Number: 212-992-9739
- Email: shabnam.javdani@nyu.edu
-
Contact:
- Erin Godfrey, PhD
- Phone Number: (212) 998-5396
- Email: erin.godfrey@nyu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SAFE Spaces training and coaching
Staff in facilities assigned to this arm are offered the SAFE Spaces training and coaching model.
|
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.
|
No Intervention: Training as Usual
Staff in facilities assigned to this arm receive training as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decreases in Suicidal Ideation Questionnaire (Davis, 1992) and suicide subscale of Massachusetts Youth Screening Instrument (Grisso et al., 2001)
Time Frame: 1 year
|
Change in suicide ideation, thoughts, and behaviors
|
1 year
|
Decreases on Self-Injurious Thoughts and Behaviors Interview (Nock et al., 2007)
Time Frame: 1 year
|
Change in self-harm thoughts and behaviors
|
1 year
|
Decreases on internalizing and externalizing subscales of Massachusetts Youth Screening Instrument (Grisso et al., 2001)
Time Frame: 1 year
|
Change in mental health correlates of suicide
|
1 year
|
Decreased burnout and increased job efficacy on the Professional Quality of Life measure (Stramm, 2016) and the Maslach Burnout Inventory
Time Frame: 1 year
|
Change in staff burnout and job efficacy
|
1 year
|
Change in responses on the Inventory of Depression and Anxiety Symptoms (Watson et al., 2007)
Time Frame: 1 year
|
Change in staff mental health
|
1 year
|
Increased suicide knowledge and response skills from Tennessee's state-wide gatekeeper training (Schut & Lockman, 2013)
Time Frame: 1 year
|
Change in suicide knowledge and response skills
|
1 year
|
Increased self-harm knowledge response skills from Tennessee's state-wide gatekeeper training (Schut & Lockman, 2013)
Time Frame: 1 year
|
Change in self-harm knowledge and response skills
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 23, 2022
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
May 31, 2025
Study Registration Dates
First Submitted
December 1, 2022
First Submitted That Met QC Criteria
December 19, 2022
First Posted (Actual)
December 20, 2022
Study Record Updates
Last Update Posted (Actual)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-FY2019-3228
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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