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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03655470
Other study ID # 1804002013
Secondary ID 1R34MH114307-01A
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date December 1, 2022

Study information

Verified date January 2024
Source Brown University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 1, 2022
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility 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 Design


Intervention

Behavioral:
Safety Planning
Safety planning is an individual coping intervention to reduce suicidal risk in adolescents
Standard care
Standard care entails sending an adolescent for an emergency evaluation for suicidal risk in an Emergency Department

Locations

Country Name City State
United States Brown Univerity Providence Rhode Island
United States Rhode Island Family Court Providence Rhode Island

Sponsors (3)

Lead Sponsor Collaborator
Brown University National Institute of Mental Health (NIMH), The Miriam Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Suicidal Ideation Score on Suicidal Ideation Questionnaire; higher is worse; range 0 to180 Past month ideation at follow-up points
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