Suicide and Self HarmNCT02981420
Implementing a Brief Suicide Intervention for High Risk Youth With Front-Line Juvenile Justice Staff
A study testing Safety planning in people with Suicide and Self Harm, run by Rhode Island Hospital at 1 site in United States.
Trial summary
A youth's contact with the juvenile justice system represents an opportune moment for suicide screening and brief suicide intervention for indicated youth. This study will provide data on the novel implementation of an evidence-based brief suicide intervention, safety planning, administered by front-line juvenile… Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide and Self Harm
- 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
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Court-involved non-incarcerated (CINI) youth,
- ages 12-17
- Legal guardian available to consent for juvenile's participation,
- Juvenile is English speaking, and
- Juvenile flags in the caution or warning range of the MAYSI-2.
- Court-involved non-incarcerated (CINI) youth,
Show all 10Show fewer
- ages 12-17
- Legal guardian available to consent for juvenile's participation,
- Juvenile is English speaking, and
- Juvenile does not flag in the caution or warning range of the MAYSI-2
Who cannot join
- observable cognitive, developmental delays, or psychosis that would interfere with completing consent, assessment or intervention, and
- Juvenile meets hospital level of care for imminent suicide risk.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Rhode Island Family Court
Providence, Rhode Island, 02903
Kathleen Kemp, Ph.D., 203-619-1692, kkemp@lifespan.org
About this study
A youth's contact with the juvenile justice system represents an opportune moment for suicide screening and brief suicide intervention for indicated youth. This study will provide data on the novel implementation of an evidence-based brief suicide intervention, safety planning, administered by front-line juvenile court staff for suicidal court-involved non-incarcerated youth. Data will inform the dissemination and implementation of suicide brief interventions to be delivered by front-line staff at the time of mental health screening in the juvenile justice system. The proposed study is consistent with the NIMH Strategic Plan by testing an intervention for effectiveness in community settings (Strategy 3.3) and establishing a research-practice partnership to improve D\&I of evidence-based MH services (4.2). The unique service delivery by JJ court staff also supports the NIMH goals to develop innovative service delivery models (Strategy 4.3) as well as validate a MH intervention for an underserved population (Strategy 4.1). This proposal also addresses the Healthy People 2020 goals of reducing suicide attempts (MHMD-2).
Read the detailed description
Suicide and suicidal behaviors among youth in the United States represents a significant public health problem. Youth involved in the juvenile justice system have a greater burden of risk factors associated with suicide ideation and behaviors as compared to their non-justice involved peers, placing these youth at greater risk for suicide. Thus, the overall goal of this Mentored Patient-Oriented Research Career Development Award (K23) is to support the applicant in developing the skills to launch an independent research program focused on the dissemination and implementation of evidence-based interventions for court-involved non-incarcerated (CINI) youth involved in the juvenile justice system to reduce psychiatric morbidity. Specific training goals are: (1) engage in intensive clinical and research training to increase my expertise in conducting brief interventions for adolescent suicide, (2) develop expertise in dissemination and implementation strategies and research in the juvenile justice system, (3) achieve skills in mixed-method research methodology including design and analysis of studies to support causal inference when randomization is not possible. The applicant will pursue these goals through a combination of mentoring, didactics, and practical experience. Specific training goals for this 5-year-period will be achieved under the mentorship of Drs. Anthony Spirito (Brown University), Marina Tolou-Shams (UCSF), Gina Vincent (UMASS Medical School), and Peter Friedmann (Baystate Health). The objective of the proposed research study is to 1) identify individual-, administrative-, and system-level factors that promote or hinder uptake of a brief suicide intervention conducted by front-line juvenile justice staff with CINI youth and 2) implement an evidence-based brief intervention, safety planning, for suicidal CINI youth and evaluate its utility with these youth. In the Treatment Adaptation phase, 12 juvenile justice stakeholders will be interviewed pre- and post-intervention implementation, as well as 24 youth and 24 caregivers 3-months post-intervention, about the acceptability of the brief intervention in the juvenile court setting. In the Treatment Trial phase, we will examine the effectiveness of a safety planning intervention for indicated suicidal youth in reducing suicidal ideation, in reducing suicidal events (suicide attempts as well as emergency evaluations and psychiatric hospitalizations for suicidality), increased engagement in outpatient mental health treatment, and improved youth motivation for treatment. CINI juveniles, ages 12-17, (N=100 for baseline (historical control) cohort; N=100 for efficacy trial; N=100 for alternative causal design) and a caregiver will be recruited from the juvenile court to participate in the current study. CINI juveniles in the efficacy trial will receive the evidenced-based brief suicide intervention as part of standard of care and will be compared to historical control and alternative causal design. Baseline data will be collected as part of routine care. Youth and a caregiver will be re-assessed at 3 months subsequent to the juvenile's initial court appointment.
- Conditions
- Suicide and Self Harm
- Being tested
- Safety planning
- Medical subject headings
- Suicide, 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 Intervention. This brief one-session intervention, based on cognitive behavioral principles, is designed to help individuals identify a concrete list of coping strategies and social supports that youth can utilize preceding or during a crisis to lower imminent risk of suicidal behavior. In youth who also report nonsuicidal self-injurious behavior (NSSI), the safety plan will address both suicidal and nonsuicidal behavior. The plan helps youth identify possible triggers to SI/crisis including self-monitoring of suicidal thoughts, feelings, and behaviors; advance planning to remove lethal means; determine distress tolerance/emotion regulation skills that may be helpful; identify accessible social supports to target hopelessness/sense of isolation; reinforce the commitment to seek treatment; and, how and where to access emergency care.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention | No intervention | Pre-intervention baseline comparison |
| Safety Planning | Experimental | Intervention group Receives: Behavioral: Safety planning |
| Regression discontinuity | No intervention | Subthreshold no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Injurious Thoughts and Behaviors Interview 2.0 (SITBI 2.0) Short Form
Structured interview designed to assess the presence, frequency, and characteristics of a broad array of self-injurious thoughts and behaviors
Measured: 3 months
Suicide Ideation Questionnaire (SIQ) - Junior
assesses the frequency of suicidal ideation
Measured: 3 months
Child and Adolescent Services Assessment
parent report of utilization of MH services and operationalized as a composite score of suicide attempts and emergency interventions for acute suicidality assessed by the Child and Adolescent Services Assessment (CASA)
Measured: 3 months
Treatment Attendance
Attendance at first treatment appointment and total number of treatment sessions attended will be collected by contacting each juveniles' treatment provider at the 3-month follow-up
Measured: 3 months
Recidivism
Collateral data gathered from court database). Juveniles' recidivism rates (e.g., new arrests), description of related charges (e.g., substance-related, property) and time detained/incarcerated
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 posted5 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMay 2019 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide and Self HarmStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Kathleen Kemp, Ph.D., Principal investigator, RIH/Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981420
- Sponsor's protocol ID
- 927079
- Other IDs
- K23MH111606
- Status last verified
- Nov 2016
- First submitted
- 28 Nov 2016
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Brief Suicide Intervention for High Risk Youth With Front-Line Juvenile Justice Staff
- ClinicalTrials.gov ID
- NCT02981420
- Acronym / sponsor ID
- 927079
- Conditions
- Suicide and Self Harm
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2016
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A youth's contact with the juvenile justice system represents an opportune moment for suicide screening and brief suicide intervention for indicated youth. This study will provide data on the novel implementation of an evidence-based brief suicide intervention, safety planning, administered by front-line juvenile court staff for suicidal court-involved non-incarcerated youth. Data will inform the dissemination and implementation of suicide brief interventions to be delivered by front-line staff at the time of mental health screening in the juvenile justice system. The proposed study is consistent with the NIMH Strategic Plan by testing an intervention for effectiveness in community settings (Strategy 3.3) and establishing a research-practice partnership to improve D\&I of evidence-based MH services (4.2). The unique service delivery by JJ court staff also supports the NIMH goals to develop innovative service delivery models (Strategy 4.3) as well as validate a MH intervention for an underserved population (Strategy 4.1). This proposal also addresses the Healthy People 2020 goals of reducing suicide attempts (MHMD-2).
Detailed description
Suicide and suicidal behaviors among youth in the United States represents a significant public health problem. Youth involved in the juvenile justice system have a greater burden of risk factors associated with suicide ideation and behaviors as compared to their non-justice involved peers, placing these youth at greater risk for suicide. Thus, the overall goal of this Mentored Patient-Oriented Research Career Development Award (K23) is to support the applicant in developing the skills to launch an independent research program focused on the dissemination and implementation of evidence-based interventions for court-involved non-incarcerated (CINI) youth involved in the juvenile justice system to reduce psychiatric morbidity. Specific training goals are: (1) engage in intensive clinical and research training to increase my expertise in conducting brief interventions for adolescent suicide, (2) develop expertise in dissemination and implementation strategies and research in the juvenile justice system, (3) achieve skills in mixed-method research methodology including design and analysis of studies to support causal inference when randomization is not possible. The applicant will pursue these goals through a combination of mentoring, didactics, and practical experience. Specific training goals for this 5-year-period will be achieved under the mentorship of Drs. Anthony Spirito (Brown University), Marina Tolou-Shams (UCSF), Gina Vincent (UMASS Medical School), and Peter Friedmann (Baystate Health). The objective of the proposed research study is to 1) identify individual-, administrative-, and system-level factors that promote or hinder uptake of a brief suicide intervention conducted by front-line juvenile justice staff with CINI youth and 2) implement an evidence-based brief intervention, safety planning, for suicidal CINI youth and evaluate its utility with these youth. In the Treatment Adaptation phase, 12 juvenile justice stakeholders will be interviewed pre- and post-intervention implementation, as well as 24 youth and 24 caregivers 3-months post-intervention, about the acceptability of the brief intervention in the juvenile court setting. In the Treatment Trial phase, we will examine the effectiveness of a safety planning intervention for indicated suicidal youth in reducing suicidal ideation, in reducing suicidal events (suicide attempts as well as emergency evaluations and psychiatric hospitalizations for suicidality), increased engagement in outpatient mental health treatment, and improved youth motivation for treatment. CINI juveniles, ages 12-17, (N=100 for baseline (historical control) cohort; N=100 for efficacy trial; N=100 for alternative causal design) and a caregiver will be recruited from the juvenile court to participate in the current study. CINI juveniles in the efficacy trial will receive the evidenced-based brief suicide intervention as part of standard of care and will be compared to historical control and alternative causal design. Baseline data will be collected as part of routine care. Youth and a caregiver will be re-assessed at 3 months subsequent to the juvenile's initial court appointment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention | No intervention | –Pre-intervention baseline comparison |
| Safety Planning | Experimental | Behavioral: Safety planningIntervention group |
| Regression discontinuity | No intervention | –Subthreshold no intervention |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Court-involved non-incarcerated (CINI) youth,
- ages 12-17
- Legal guardian available to consent for juvenile's participation,
- Juvenile is English speaking, and
- Juvenile flags in the caution or warning range of the MAYSI-2.
Key exclusion criteria (2 listed)
- observable cognitive, developmental delays, or psychosis that would interfere with completing consent, assessment or intervention, and
- Juvenile meets hospital level of care for imminent suicide risk.
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 Intervention. This brief one-session intervention, based on cognitive behavioral principles, is designed to help individuals identify a concrete list of coping strategies and social supports that youth can utilize preceding or during a crisis to lower imminent risk of suicidal behavior. In youth who also report nonsuicidal self-injurious behavior (NSSI), the safety plan will address both suicidal and nonsuicidal behavior. The plan helps youth identify possible triggers to SI/crisis including self-monitoring of suicidal thoughts, feelings, and behaviors; advance planning to remove lethal means; determine distress tolerance/emotion regulation skills that may be helpful; identify accessible social supports to target hopelessness/sense of isolation; reinforce the commitment to seek treatment; and, how and where to access emergency care. | Behavioural | Safety Planning |
Primary outcome
Self-Injurious Thoughts and Behaviors Interview 2.0 (SITBI 2.0) Short Form
Time frame: 3 months
Structured interview designed to assess the presence, frequency, and characteristics of a broad array of self-injurious thoughts and behaviors
Suicide Ideation Questionnaire (SIQ) - Junior
Time frame: 3 months
assesses the frequency of suicidal ideation
Child and Adolescent Services Assessment
Time frame: 3 months
parent report of utilization of MH services and operationalized as a composite score of suicide attempts and emergency interventions for acute suicidality assessed by the Child and Adolescent Services Assessment (CASA)
Treatment Attendance
Time frame: 3 months
Attendance at first treatment appointment and total number of treatment sessions attended will be collected by contacting each juveniles' treatment provider at the 3-month follow-up
Recidivism
Time frame: 3 months
Collateral data gathered from court database). Juveniles' recidivism rates (e.g., new arrests), description of related charges (e.g., substance-related, property) and time detained/incarcerated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Suicide and Self Harm
Active, not recruitingPhase 2/3
Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Suicidal Ideation, Major Depressive Disorder
Recruiting
Risk and Resilience to Suicide Following Late-Life Spousal Bereavement
Suicide, Bereavement
Not yet recruitingPhase 2
Assessing of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
PTSD, PTSD - Post Traumatic Stress Disorder
Not yet recruiting
Reducing Stigma - A Treatment for Early Psychosis to Prevent Suicide
Suicide, Mental Health Stigma
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
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.
Kathleen Kemp, Ph.D. principal investigator
RIH/Brown University
1 site 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 Suicide and Self Harm, run by Rhode Island Hospital at 1 site 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 10 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Kemp, Ph.D. (4017938269, kkemp@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Injurious Thoughts and Behaviors Interview 2.0 (SITBI 2.0) Short Form (time frame: 3 months). The study lists 5 primary outcomes in all. 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 6 Mar 2017.