- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT06712147
MHE3 임상시험 - 장애물 극복
정신 건강 서비스와의 연결을 개선하기 위한 Promotora 중심 커뮤니티 협력
The goal of this clinical trial is to increase and strengthen connections between Latino/a individuals and mental health services. Through this intervention, the investigators aim to improve mental health literacy, decrease stigma, increase coping skills, and increase mental health help seeking, even before they are in crisis. Participants will be asked to participate in six educational sessions hosted by Promotores de Salud.
연구 개요
상태
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
California
-
Palo Alto, California, 미국, 94304
- Stanford University
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria:
- Has heritage or self-identifies as Hispanic and/or Latino/a
- Must speak English or Spanish
- Primary residence is in 95116, 95122, 95127, 95112, 95111, 95121,95148, or 95133 zip codes
Exclusion criteria:
- Persons from the same household
- First degree family member
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Mental health use, education, and skill-building
Participants randomly assigned to this arm will attend a 6 week educational series that will cover topics around mental health. Data will be collected form participants at baseline (before the start of the first session), 1 week after the last session, and at 3- and 6- months after the sessions (follow ups). |
The intervention group will cover educational topics around mental health including: mental health literacy, individual coping skills, stigma reduction strategies, resources for mental health support, and mental health rights. |
|
활성 비교기: Resources in the community
Participants randomly assigned to this arm will attend a 6 week educational series that will cover topics on resources in the community. Data will be collected form participants at baseline (before the start of the first session), 1 week after the last session, and at 3- and 6- months after the sessions (follow ups). |
The control group will cover topics including: mental health resources in the community, violence (i.e. domestic violence), employment and education opportunities, housing and tenant rights, immigration and acculturation, and community team building and empowerment. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Attitudes Toward Seeking Professional Psychological Help Scale - Short Form
기간: 6 month follow up
|
The ATSPPH-SF is scored 0 to 30. Items are rated on a Likert scale (e.g., strongly disagree to strongly agree), with higher scores indicating greater openness to seeking psychological help. |
6 month follow up
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mental Health Service Use
기간: 3 month follow up and 6 month follow up.
|
Measured through a study-specific, 9-item questionnaire. Self-rated mental health status question will use a multiple choice semantic differential scale ("excellent" to "poor"). Number of poor mental health days in the past month will use a numerical scale (0 to 30 days). Mental health help-seeking questions related to wanting, tried, and successfully seeing a mental health professional will use select all that apply time point response options ("never", "in the past 3 months", "within the last 4- 6 months", "over a year ago"). |
3 month follow up and 6 month follow up.
|
|
Attitudes Toward Seeking Professional Psychological Help Scale - Short Form
기간: 1 week follow up and 3 month follow up.
|
The ATSPPH-SF is scored 0 to 30. Items are rated on a Likert scale (e.g., strongly disagree to strongly agree), with higher scores indicating greater openness to seeking psychological help. |
1 week follow up and 3 month follow up.
|
|
General Self-Efficacy Scale
기간: 1 week follow up, 3 month follow up, and 6-month follow up.
|
Measured through a 10-item questionnaire; assesses the strength of an individuals belief of their ability to respond to novel or difficult situations to deal with any associated obstacles or setbacks. Items are rated on a 4-point Likert scale (e.g., 1 = Not at all true to 4 = Exactly true), with higher scores indicating stronger self-efficacy. |
1 week follow up, 3 month follow up, and 6-month follow up.
|
|
Treatment Expectation Questionnaire
기간: 1 week follow up, 3 month follow up, and 6-month follow up.
|
Measured through a 6 item questionnaire; measure's a participants expectations about the effectiveness of their treatment. Items are rated on a Likert scale (e.g., from "not at all" to "very much"), and higher scores indicate stronger positive expectations about the treatment. |
1 week follow up, 3 month follow up, and 6-month follow up.
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jennifer A Newberry, MD, JD, MSc, Stanford University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
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
- 77672
- 5R01MD018201-03 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Data will be made available through presentations at national scientific meetings, publishing in peer reviewed journals, and uploading the processed data to publicly accessible servers, as appropriate. The investigators will conform with the HIPAA Privacy Rule under which protected health information may be used or disclosed by covered entities for research purposes and protect against the involuntary release of data that could identify research participants as stated in the confidentiality statement.
In accordance with guidelines set by NIH's Policy for Data Management and Sharing, data from this study will be made publicly available through Stanford's Digital Repository (SDR) and the Center for Open Science's OSF repository.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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