Suicidal IdeationSafetyNCT03655470
Safety Planning in Juvenile Justice for Suicidal Youth
A study testing Safety Planning in people with Suicidal Ideation and Suicide, Attempted, run by Brown University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Suicidal Ideation, Suicide, Attempted, Nonsuicidal Self-injury
- What is being tested?
- Safety Planning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2019to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rhode Island Family Court
Providence, Rhode Island, 02903
Brown Univerity
Providence, Rhode Island, 02912
About this study
Official title: 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.
Read the 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.
- Being tested
- Safety Planning, Standard care
- Keywords
- suicidal behavior, nonsuicidal self injury, adolescents
- Medical subject headings
- Suicidal Ideation, Suicide, Attempted, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety PlanningBehavioural
Safety planning is an individual coping intervention to reduce suicidal risk in adolescents
Standard careBehavioural
Standard care entails sending an adolescent for an emergency evaluation for suicidal risk in an Emergency Department
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Safety Planning |
| 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 Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Suicidal Ideation
Score on Suicidal Ideation Questionnaire; higher is worse; range 0 to180
Measured: Past month ideation at 1 and 3 month follow-up points
Secondary outcomes (1)
Suicide Attempts
Whether a participant reported a suicide attempt
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Jan 2019
- Primary completion1 Oct 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 group randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The Miriam Hospital
- Responsible party
- Sponsor
- Investigators
- Anthony Spirito, PhD, Principal investigator, Brown U
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655470
- Sponsor's protocol ID
- 1804002013
- Other IDs
- 1R34MH114307-01A1
- Acronym
- Safety
- Status last verified
- Oct 2024
- First submitted
- 30 Aug 2018
- Last updated
- 12 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Brief Intervention for Suicidality and Nonsuicidal Self-Injury Among Youth in the Juvenile Justice System
- ClinicalTrials.gov ID
- NCT03655470
- Acronym / sponsor ID
- Safety / 1804002013
- Keywords
- suicidal behavior, nonsuicidal self injury, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The Miriam Hospital
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Safety Planning | Experimental | Behavioral: Safety PlanningThis 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 | Behavioral: Standard careIf 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 |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safety PlanningSafety planning is an individual coping intervention to reduce suicidal risk in adolescents | Behavioural | Safety Planning |
| Standard careStandard care entails sending an adolescent for an emergency evaluation for suicidal risk in an Emergency Department | Behavioural | Standard Care |
Primary outcome
Change in Suicidal Ideation
Time frame: Past month ideation at 1 and 3 month follow-up points
Score on Suicidal Ideation Questionnaire; higher is worse; range 0 to180
1 secondary outcome
Suicide Attempts
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Spirito, PhD principal investigator
Brown U
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Planning in people with Suicidal Ideation and Suicide, Attempted, run by Brown University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Suicidal Ideation (time frame: Past month ideation at 1 and 3 month follow-up points). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.