Engaging Family Members During Early SUD Treatment: A Hybrid Trial
The goal of this study is a fractional factorial optimization trial to optimize engagement in a CRAFT program for family members with loved ones in outpatient treatment for a substance use disorder.
This study aims to identify family engagement strategies that are feasible, acceptable, and appropriate and effective in increasing family member initiation with CRAFT. Participants will complete an iterative, online process where they will evaluate and rank different engagement strategies to identify the most optimal in increasing engagement and then participate in an optimization trial to identify which strategies were most effective in increasing family member engagement.
연구 개요
상태
상세 설명
Family members (FMs) of people with substance use disorder (SUD)-including biological, extended, or chosen family-face chronic stress and are at high risk for mental and physical health problems. The impact is worsened by stigma, guilt, shame, and self-blame that often accompany a loved one's substance use, leading to social isolation and uncertainty about how to support recovery. Although FMs are motivated to help with treatment navigation, many do not seek support for themselves. Programs like Community Reinforcement and Family Training (CRAFT) can support FMs and provide tools to improve their own lives while assisting their loved one's recovery. While CRAFT is well-established in community settings for increasing a family member's initiation into treatment, its applicability in clinical SUD settings is less clear. It remains unknown whether CRAFT can enhance patient treatment retention in clinical settings and whether FMs who might not seek care would participate.
To advance the science of engaging and supporting families impacted by SUD, investigators will (1) Conduct an iterative online process with FMs and clinic staff to identify potential family engagement strategies that community health centers (CHCs) can deliver that are effective, feasible, acceptable, and appropriate, and (2) Test those strategies using a fractional factorial trial.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Kat Nameth, MS
- 전화번호: 650-542-9699
- 이메일: knameth@stanford.edu
연구 연락처 백업
- 이름: Kirsten Becker, MPH
- 전화번호: (866) 697-5620
- 이메일: becker@rand.org
연구 장소
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California
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San Diego, California, 미국, 92012
- Family Health Centers of San Diego
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연락하다:
- Joe Sepulveda, MD
- 전화번호: (619) 515-2300
- 이메일: joes@fhcsd.org
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
FAMILY MEMBERS:
Inclusion Criteria:
- 18 years old or older
- A parent, child, sibling, spouse/romantic partner, or other adult supporting a loved one who initiated SUD treatment in past 3 months
- Cohabitating with their loved one
- In frequent contact (in-person or virtual) with their loved one (at least 3x/week)
- Not worried about potential physical harm from their loved one
- Report no illicit drug use in the past year
PATIENTS:
Inclusion Criteria:
- 18 years old or older
- In frequent contact with a family member (at least 3x/week) that they cohabitate with
- Have initiated substance use treatment in past 3 months
CLINIC PROVIDERS:
Inclusion Criteria:
- Counselor/Clinician providing care at our partner clinic for SUD
Exclusion Criteria (ALL):
- Does not have capacity to consent (e.g., severe cognitive impairment, in active psychosis, or developmental disabilities)
- Does not understand English fluently
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Aim 2: Arm 1
All 4 Engagement Strategies
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Engagement Strategy
Engagement Strategy
Engagement Strategy
Engagement Strategy
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활성 비교기: Aim 2: Arm 2
Strategies 1-3
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Engagement Strategy
Engagement Strategy
Engagement Strategy
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활성 비교기: Aim 2: Arm 3
Strategies 1-2
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Engagement Strategy
Engagement Strategy
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활성 비교기: Aim 2: Arm 4
Strategies 2-4
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Engagement Strategy
Engagement Strategy
Engagement Strategy
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활성 비교기: Aim 2: Arm 5
Strategies 3-4
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Engagement Strategy
Engagement Strategy
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|
활성 비교기: Aim 2: Arm 6
Strategies 1 & 3
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Engagement Strategy
Engagement Strategy
|
|
활성 비교기: Aim 2: Arm 7
Strategies 2 & 4
|
Engagement Strategy
Engagement Strategy
|
|
활성 비교기: Aim 2: Arm 8
Strategies 1, 2 & 4
|
Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
활성 비교기: Aim 2: Arm 9
Strategies 2-3
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Engagement Strategy
Engagement Strategy
|
|
활성 비교기: Aim 2: Arm 10
Strategies 1, 3 & 4
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Engagement Strategy
Engagement Strategy
Engagement Strategy
|
|
활성 비교기: Aim 2: Arm 11
Strategy 1
|
Engagement Strategy
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활성 비교기: Aim 2: Arm 12
Strategy 2
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Engagement Strategy
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활성 비교기: Aim 2: Arm 13
Strategy 3
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Engagement Strategy
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활성 비교기: Aim 2: Arm 14
Strategy 4
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Engagement Strategy
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활성 비교기: Aim 2: Arm 15
Strategy 1 & 4
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Engagement Strategy
Engagement Strategy
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위약 비교기: Aim 2: Arm 16
No Strategies
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No engagement strategies
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Attendance
기간: 2 months after baseline
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Attend at least 1 eINSPIRE session
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2 months after baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Feasibility of Engagement Strategies
기간: 6 months from enrollment
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Assessed via the Intervention Usability Scale, score of 70+ indicates feasibility
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6 months from enrollment
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Acceptability of Engagement Strategies
기간: 6 months from enrollment
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Assessed via the Acceptability of Intervention Measure; 70%+ agree/strongly agree indicates acceptability
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6 months from enrollment
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Appropriateness of Engagement Strategies
기간: 6 months from enrollment
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Assessed via the Intervention Appropriateness Measure; 70%+ agree/strongly agree indicates appropriateness
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6 months from enrollment
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Karen Osilla, PhD, Stanford University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
- IRB-86357
- 1R61DA064789-01 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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
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. .
Engagement Strategy 1에 대한 임상 시험
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The University of QueenslandNational Health and Medical Research Council, Australia모병
-
Montreal Heart InstituteInstitut de Recherches Cliniques de Montreal; Royal Victoria Hospital, Canada; Queen Elizabeth... 그리고 다른 협력자들완전한
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The University of Texas Health Science Center,...National Heart, Lung, and Blood Institute (NHLBI); United States Department of Defense; Defence... 그리고 다른 협력자들완전한