Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02981420
Other study ID # 927079
Secondary ID K23MH111606
Status Recruiting
Phase N/A
First received November 28, 2016
Last updated March 2, 2017
Start date December 2016
Est. completion date May 2020

Study information

Verified date November 2016
Source Rhode Island Hospital
Contact Kathleen Kemp, Ph.D.
Phone 4017938269
Email kkemp@lifespan.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date May 2020
Est. primary completion date May 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 17 Years
Eligibility Inclusion Criteria:

- 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.

Inclusion for second cohort:

- Court-involved non-incarcerated (CINI) youth,

- 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

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Safety planning
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.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Rhode Island Hospital National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 3 months
Primary Suicide Ideation Questionnaire (SIQ) - Junior assesses the frequency of suicidal ideation 3 months
Primary 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) 3 months
Primary 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 3 months
Primary 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 3 months