- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02981420
Implementing a Brief Suicide Intervention for High Risk Youth With Front-Line Juvenile Justice Staff
2. März 2017 aktualisiert von: Rhode Island Hospital
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).
Studienübersicht
Status
Unbekannt
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
300
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Rhode Island
-
Providence, Rhode Island, Vereinigte Staaten, 02903
- Rekrutierung
- Rhode Island Family Court
-
Kontakt:
- Kathleen Kemp, Ph.D.
- Telefonnummer: 203-619-1692
- E-Mail: kkemp@lifespan.org
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
12 Jahre bis 17 Jahre (Kind)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Kein Eingriff: Pre-intervention
Pre-intervention baseline comparison
|
|
Experimental: Safety Planning
Intervention group
|
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.
|
Kein Eingriff: Regression discontinuity
Subthreshold no intervention
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Self-Injurious Thoughts and Behaviors Interview 2.0 (SITBI 2.0) Short Form
Zeitfenster: 3 months
|
Structured interview designed to assess the presence, frequency, and characteristics of a broad array of self-injurious thoughts and behaviors
|
3 months
|
Suicide Ideation Questionnaire (SIQ) - Junior
Zeitfenster: 3 months
|
assesses the frequency of suicidal ideation
|
3 months
|
Child and Adolescent Services Assessment
Zeitfenster: 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)
|
3 months
|
Treatment Attendance
Zeitfenster: 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
|
3 months
|
Recidivism
Zeitfenster: 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
|
3 months
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Kathleen Kemp, Ph.D., RIH/Brown University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Dezember 2016
Primärer Abschluss (Voraussichtlich)
1. Mai 2019
Studienabschluss (Voraussichtlich)
1. Mai 2020
Studienanmeldedaten
Zuerst eingereicht
28. November 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
30. November 2016
Zuerst gepostet (Schätzen)
5. Dezember 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
6. März 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
2. März 2017
Zuletzt verifiziert
1. November 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 927079
- K23MH111606 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Nein
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