- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03655470
Safety Planning in Juvenile Justice for Suicidal Youth (Safety)
October 17, 2024 updated by: Brown University
Screening and Brief Intervention for Suicidality and Nonsuicidal Self-Injury Among Youth in the Juvenile Justice System
This study will examine the feasibility and acceptability of a program designed to conduct safety planning with youth in the juvenile justice system who are at risk for a suicide attempt and/or self-injury and to increase the possibility of them receiving outpatient mental health treatment.
After training staff in the intervention, the investigators will pilot test the safety planning intervention and gather information on how well it worked on reducing self-harm, getting families to follow up with referrals for mental health care, and how often they attend treatment.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The Juvenile Justice System (JJS) has not implemented any evidenced-based interventions that address suicidal behavior or nonsuicidal self-injury, hereafter referred collectively to as self-injury, with JJS-involved youth.
This application proposes to test a scalable intervention, safety planning, that aims to reduce self-injury in adolescents involved in the JJS.
Safety planning, which can be a stand-alone brief intervention, was cited as a best practice by the Suicide Prevention Resource Center/American Foundation for Suicide Prevention Best Practices Registry for Suicide Prevention.
This study will have two phases.
In Phase I, the investigators will conduct an open trial with 10 adolescents which will allow us to make any modifications necessary for using the protocol in a Probation Department.
The investigators will then randomize 60 youth on Probation who screen positive for recent self-injury into standard care or the safety planning intervention.
Counselors with community mental health experience embedded in Probation will conduct the intervention, consistent with the co-responder model found across JJS in the U.S. in which a Probation Officer works collaboratively with a mental health professional to coordinate care.
In order to further conduct the study under conditions most relevant to a future implementation trial, the investigators will also employ a training approach that has been successfully implemented in a psychiatric hospital with Bachelors and Masters level staff.
In Phase II, of the study, the investigators will: a) conduct qualitative interviews in Probation about attitudes toward the intervention as well as barriers to a future, larger implementation trial; and b) contract with the National Center for Mental Health and Juvenile Justice to conduct a Sequential Intercept Model (SIM) Mapping.
The SIM is a conceptual framework to outline a series of "points of interception" along the JJS continuum in a state where screening and brief intervention may be implemented.
In the Mapping, the investigators will examine the JJS continuum from arrest; to an initial hearing; to jail awaiting trial or adjudication; incarceration; to release or reentry; and finally, to community supervision.
These data will provide a working framework to help assess current views within the statewide JJS as a starting point to proposing a future, larger trial.
This research also has the potential to directly inform treatment practices in JJ settings and has significant implications for scalability and dissemination in order to build a stronger, more effective system of mental health/JJS collaboration around self-injury screening and intervention.
Study Type
Interventional
Enrollment (Actual)
59
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 Locations
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Family Court
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Providence, Rhode Island, United States, 02912
- Brown Univerity
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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
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Legal guardian available to consent for juvenile's participation
- Juvenile and parents are English or Spanish speaking
- Juvenile flags in on the screening measure used in court with respect to suicidal ideation or nonsuicidal self-injury.
Exclusion Criteria:
- None
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Safety Planning
This brief intervention, consists of an in-person and follow-up phone call that are based on cognitive behavioral principles designed to help identify a concrete list of coping strategies and social supports that youth can utilize preceding or during a crisis to lower imminent risk of nonsuicidal self-injury or suicidal behavior.
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Safety planning is an individual coping intervention to reduce suicidal risk in adolescents
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|
Active Comparator: Standard Care
If a teen has a positive screen for suicide risk, the Probation Officer completes a "secondary screener" built into the court screening instrument to determine whether there is concern of current and/or imminent risk.
If a teen endorses nonsuicidal self-injury more than once in the prior year, then the Probation Officer asks about frequency and severity.
If there is ongoing concern of risk for self-injurious behavior, then the Probation Officer arranges for a crisis evaluation in the Emergency Department.
If the teen is not judged to be at imminent risk, the Probation Officer makes a referral back to the current treatment provider or to a community mental health clinic.
In either case, the parents and youth receive a packet with mental health resources
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Standard care entails sending an adolescent for an emergency evaluation for suicidal risk in an Emergency Department
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Suicidal Ideation
Time Frame: Past month ideation at 1 and 3 month follow-up points
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Score on Suicidal Ideation Questionnaire; higher is worse; range 0 to180
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Past month ideation at 1 and 3 month follow-up points
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suicide Attempts
Time Frame: 3 months
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Whether a participant reported a suicide attempt
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anthony Spirito, PhD, Brown U
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)
January 1, 2019
Primary Completion (Actual)
October 1, 2022
Study Completion (Actual)
December 1, 2022
Study Registration Dates
First Submitted
August 30, 2018
First Submitted That Met QC Criteria
August 30, 2018
First Posted (Actual)
August 31, 2018
Study Record Updates
Last Update Posted (Estimated)
November 12, 2024
Last Update Submitted That Met QC Criteria
October 17, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1804002013
- 1R34MH114307-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
The final study protocol will contain the information necessary to reproduce the findings in other populations.
The protocol will include a copy of this grant application including Specific Aims and study population; recruitment and enrollment information; the measures collected and coding of the measures and subscales; the clinician intervention procedures; data analyses; syntax for data summary, and data analysis plans
IPD Sharing Time Frame
1 year after completion of all follow-up data
IPD Sharing Access Criteria
Contact PI
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
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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