- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02981420
Implementing a Brief Suicide Intervention for High Risk Youth With Front-Line Juvenile Justice Staff
2017년 3월 2일 업데이트: 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).
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (예상)
300
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Kathleen Kemp, Ph.D.
- 전화번호: 4017938269
- 이메일: kkemp@lifespan.org
연구 장소
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Rhode Island
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Providence, Rhode Island, 미국, 02903
- 모병
- Rhode Island Family Court
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연락하다:
- Kathleen Kemp, Ph.D.
- 전화번호: 203-619-1692
- 이메일: kkemp@lifespan.org
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
12년 (어린이)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Pre-intervention
Pre-intervention baseline comparison
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실험적: Safety Planning
Intervention group
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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.
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간섭 없음: Regression discontinuity
Subthreshold no intervention
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Self-Injurious Thoughts and Behaviors Interview 2.0 (SITBI 2.0) Short Form
기간: 3 months
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Structured interview designed to assess the presence, frequency, and characteristics of a broad array of self-injurious thoughts and behaviors
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3 months
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Suicide Ideation Questionnaire (SIQ) - Junior
기간: 3 months
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assesses the frequency of suicidal ideation
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3 months
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Child and Adolescent Services Assessment
기간: 3 months
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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)
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3 months
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Treatment Attendance
기간: 3 months
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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
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3 months
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Recidivism
기간: 3 months
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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
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3 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Kathleen Kemp, Ph.D., RIH/Brown University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2016년 12월 1일
기본 완료 (예상)
2019년 5월 1일
연구 완료 (예상)
2020년 5월 1일
연구 등록 날짜
최초 제출
2016년 11월 28일
QC 기준을 충족하는 최초 제출
2016년 11월 30일
처음 게시됨 (추정)
2016년 12월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 3월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 3월 2일
마지막으로 확인됨
2016년 11월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Safety planning에 대한 임상 시험
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University of California, Los AngelesDuke University모병
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M.D. Anderson Cancer Center모병
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Royal Marsden NHS Foundation TrustInstitute of Cancer Research, United Kingdom알려지지 않은
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Maureen LyonNational Institute of Mental Health (NIMH)완전한
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VA Office of Research and Development완전한