- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02174224
At-risk Intervention and Mentoring Evaluation (AIM)
Program Evaluation of a Hospital-based Violence Intervention Program (At-risk Intervention and Mentoring)
연구 개요
상세 설명
This study will be a randomized controlled trial. Youth presenting to the emergency department with an intentional injury (gunshot wound, stab wound, or assault) will be given a behavioral assessment. Participants will be categorized according to risk (low, moderate, high). Only moderate or high youth will continue in the study and be randomized. Low risk youths will receive the medical standard of care and be re-assessed at 18 months.
Randomization will place participants in one of two arms. Arm 1 will receive the standard of care PLUS a brief intervention with AIM outreach workers. Arm 2 will receive standard medical care PLUS a brief intervention PLUS case management.
Every randomized youth will be assessed for risk and protective factors and have have data collected at 6-month intervals (0, 6, 12, 18 months).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Colorado
-
Denver, Colorado, 미국, 80204
- Denver Health Medical Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 14-24 years of age , Intentional Injury (Gunshot Wound, Stab Wound, Assault)
Exclusion Criteria:
- Younger than 14, 25 or older, non-English speaking, unable to give informed consent/assent, sexual assaults, domestic violence, child neglect/abuse.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: SMC + BI + Case Management
This arm will include all interventions in Standard Medical Care + Brief Intervention Arm.
Case management will also be given to this arm.
General needs based assessments will be conducted by the outreach worker.
These assessments will be done at the hospital or at the youth's home, whichever they prefer.
This assessment tool addresses education, vocational training, employment, housing, medical insurance, follow-up care and pro-social activities.
Although each youth in this arm will receive the same needs-based assessment, individual youth will have variable needs, which will guide each unique and individualized case management plan.
|
Goals of the bedside intervention will be to help the patient understand their risky behaviors that resulted in the injury and to assess and deescalate any threat of retaliatory violence by the patient.
The outreach worker will: (1) develop a rapport with the patient by introducing themselves and describing their (outreach worker's) background and reason for the bedside visit; (2) assess the emotional response to the current injury; (3) ensure the patient and/or family understand the nature of the injury and ED course; (4) address any immediate concerns of the patient; and (5) develop a plan for staying safe following discharge.
Case management based on needs-assessment.
Resource connection and mentoring.
This will include physician discretion for medical treatment and potentially a social worker visit as the physician sees fit for the patient.
This will also include a list of resources that are typically needed and used for violently injured youth.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Violence Risk Scale
기간: 0, 6, 12, 18 months
|
Violence Risk Scale (VRS) will be measured with each youth at 4 time points.
Change over time will be assessed and compared among study arms.
|
0, 6, 12, 18 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Composite Score
기간: 0, 6, 12, 18 months
|
Composite Score measures both risk and protective factors.
This weighted scale uses the interplay between risk and protective factors to determine overall risk for youth to become violently injured.
|
0, 6, 12, 18 months
|
School Enrollment
기간: 0, 6, 12, 18 months
|
Self-report for school enrollment will be measured and compared among arms.
|
0, 6, 12, 18 months
|
Hospital Recidivism
기간: 0, 6, 12, 18 months
|
Every six month, patients' medical records will be scanned to determine if there has been violent injury recidivism.
Medical release of Information forms will allow medical record searches from other local hospitals.
|
0, 6, 12, 18 months
|
Justice System Recidivism
기간: 0, 6, 12, 18 months
|
Self-report of criminal history.
|
0, 6, 12, 18 months
|
Employment
기간: 0, 6, 12, 18 months
|
Self-report of employment status.
|
0, 6, 12, 18 months
|
Resource Utilization
기간: 0, 6, 12, 18 months.
|
Self report of resource utilization for health care and social needs.
|
0, 6, 12, 18 months.
|
Mortality
기간: 0, 6, 12, 18 months
|
Mortality will be assessed every 6 months.
|
0, 6, 12, 18 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Katie Bakes, MD, Denver Health Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- OJJDP-2013-3579
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .
Brief Intervention에 대한 임상 시험
-
RANDNational Institute on Alcohol Abuse and Alcoholism (NIAAA)완전한
-
University of MichiganNational Institute on Drug Abuse (NIDA)완전한
-
University of MichiganNational Institute on Alcohol Abuse and Alcoholism (NIAAA)완전한
-
Seattle Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH) 그리고 다른 협력자들완전한
-
Assistance Publique - Hôpitaux de Paris아직 모집하지 않음
-
VA Office of Research and Development모집하지 않고 적극적으로