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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH114307-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| The Miriam Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety Planning | Experimental | 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. |
|
| Standard Care | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safety Planning | Behavioral | Safety planning is an individual coping intervention to reduce suicidal risk in adolescents |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Suicidal Ideation | Score on Suicidal Ideation Questionnaire; higher is worse; range 0 to180 | Past month ideation at 1 and 3 month follow-up points |
| Measure | Description | Time Frame |
|---|---|---|
| Suicide Attempts | Whether a participant reported a suicide attempt | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Spirito, PhD | Brown U | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Family Court | Providence | Rhode Island | 02903 | United States | ||
| Brown Univerity |
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
1 year after completion of all follow-up data
Contact PI
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Safety Planning: Safety planning is an individual coping intervention to reduce suicidal risk in adolescents |
| FG001 | 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 Standard care: Standard care entails sending an adolescent for an emergency evaluation for suicidal risk in an Emergency Department |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Safety Planning: Safety planning is an individual coping intervention to reduce suicidal risk in adolescents |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Suicidal Ideation | Score on Suicidal Ideation Questionnaire; higher is worse; range 0 to180 | Posted | Mean | Standard Deviation | score on a scale | Past month ideation at 1 and 3 month follow-up points |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Safety Planning: Safety planning is an individual coping intervention to reduce suicidal risk in adolescents |
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The major limitations were: 1) identification of participants eligible for the study in the various sections of the juvenile legal system with different frontline staff; and 2) follow-up rate for enrolled participants was no as high as expected due primarily to the fact that most participants exited the juvenile legal system at 3 months and therefore, at times, were unwilling to complete follow-up because they were no longer in the family court system.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony Spirito, PI | Brown University | 4014441929 | anthony_spirito@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2020 | Dec 31, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 25, 2020 | May 4, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059020 | Suicidal Ideation |
| D013406 | Suicide, Attempted |
| D016728 | Self-Injurious Behavior |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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2 group randomized controlled trial
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Outcome assessors will be blind; participants will not be told to what condition they are assigned
| Standard care | Behavioral | Standard care entails sending an adolescent for an emergency evaluation for suicidal risk in an Emergency Department |
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| Providence |
| Rhode Island |
| 02912 |
| United States |
| BG001 | 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 Standard care: Standard care entails sending an adolescent for an emergency evaluation for suicidal risk in an Emergency Department |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Massachusetts Youth Screening Instrument - Angry/Irritable subscale, | MAYSI subscale range 0 - 9, higher indicates higher levels of anger and irritability | Mean | Standard Deviation | units on a scale |
|
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
Standard care: Standard care entails sending an adolescent for an emergency evaluation for suicidal risk in an Emergency Department
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| Secondary | Suicide Attempts | Whether a participant reported a suicide attempt | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 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 Standard care: Standard care entails sending an adolescent for an emergency evaluation for suicidal risk in an Emergency Department | 0 | 30 | 0 | 30 | 0 | 30 |
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