- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07596251
Support Towards Addiction Recovery for Individuals With Criminal Legal System Involvement: The STAR Project
2026년 9월 1일 업데이트: Martha Tillson
The goal of this clinical trial is to determine whether a new, paired coaching intervention improves outcomes for individuals with criminal legal system involvement recovering from substance use disorder, as well as the loved ones of those individuals. The initial phase (Year 1) includes a small preliminary pilot examining the feasibility of the intervention.
During the full clinical trial (Years 2-5), this study aims to answer whether this approach...
- ...improves the recovering person's recovery capital?
- ...improves well-being, as well as resource knowledge and awareness, for the loved one?
- ...improves social support and connection among both individuals?
Participants will:
- Meet regularly one-on-one with their individual coaches (a Recovery Coach for the recovering person; a Loved One Coach for the loved one) during the 6 week intervention period
- Meet regularly as a group of four (both coaches and both participants) during this same period
- Complete follow-up interviews with research staff at 6- and 12-weeks after beginning the study
연구 개요
연구 유형
중재적
등록 (추정된)
8
단계
- 해당 없음
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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Recovering Persons:
- At least 18 years old
- Must have been involved with the criminal legal system (arrested, incarcerated, or on community supervision like parole or probation) within the past 12 months
- Substance use disorder within the past 12 months
- Interested in working with a recovery coach to support your recovery (defined as engaging in any changes to improve your health and wellness)
- Can identify at least one person who is supportive of their recovery.
- Loved Ones:
- At least 18 years old
- Interested in receiving additional supports and/or information about their loved one's substance use and criminal legal system involvement
- Anticipate being available for weekly participation in intervention activities
- Willing to support their loved one's recovery
Exclusion Criteria:
- Loved ones:
- Already have a professional relationship with the recovering person (e.g., as a counselor, sponsor, or peer recovery support specialist)
- Meet substance use disorder criteria for any past 30-day drug or alcohol use
- Have a history of domestic violence or protective orders.
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: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: STAR Intervention
|
The STAR intervention is a dyadic coaching model designed to support individuals with substance use disorder and criminal legal system involvement alongside their identified loved ones.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Feasibility of STAR Intervention in Dyads
기간: Immediately following intervention sessions during 6-week feasibility pilot.
|
a. Feasibility will be assessed using the STAR Project Focus Group Survey questions administered to dyad participants following intervention sessions.
A higher score indicates greater perceived feasibility.
|
Immediately following intervention sessions during 6-week feasibility pilot.
|
|
Acceptability of STAR Intervention in Dyads
기간: Immediately following intervention sessions during 6-week feasibility pilot.
|
a. Acceptability will be assessed using the Focus Group Survey questions administered to dyad participants following intervention sessions.
A higher score indicates greater perceived acceptability.
|
Immediately following intervention sessions during 6-week feasibility pilot.
|
|
Recovery capital
기간: Assessed at enrollment and 6- and 12-weeks post-enrollment
|
a.
For recovering persons: The internal and external resources that impact an individual's capacity to initiate and sustain recovery, including physical, cultural, human, and social resources.
Assessed using the Multidimensional Inventory of Recovery Capital (MIRC) a 28-item questionnaire.
Higher scores indicate greater recovery capital.
|
Assessed at enrollment and 6- and 12-weeks post-enrollment
|
|
Psychological well-being
기간: Assessed at enrollment and 6- and 12-weeks post-enrollment
|
a.
For loved ones: Positive affect, life satisfaction, and an overall sense of purpose and meaning.
Assessed using the Neuro-QOL Positive Affect and Well-Being Scale, a 23-item questionnaire, Higher scores indicate greater psychological well-being.
|
Assessed at enrollment and 6- and 12-weeks post-enrollment
|
|
SUD and CLS knowledge and resource awareness
기간: Assessed at enrollment and 6- and 12-weeks post-enrollment
|
a.
For loved ones: Knowledge regarding Substance Use Disorder (SUD) including recovery, treatment, harm reduction, and Criminal Legal System (CLS) involvement as well as awareness of local recovery and resources.
Assessed using study developed knowledge assessment questions and count of local resources known.
Higher scores indicate greater knowledge and resource awareness.
|
Assessed at enrollment and 6- and 12-weeks post-enrollment
|
|
Support functions
기간: Assessed at enrollment and 6- and 12-weeks post-enrollment
|
a.
For loved ones and recovering persons: Number and types of support functions provided by social network members.
Assessed using egocentric social network inventory questionnaire evaluating functional support provided by network members.
Higher scores indicate greater perceived social support.
|
Assessed at enrollment and 6- and 12-weeks post-enrollment
|
|
Social connection
기간: Assessed at enrollment and 6- and 12-weeks post-enrollment
|
a.
For loved ones and recovering persons: Level of trust, emotional closeness, and frequency of contact with social network members.
Assessed using egocentric social network inventory questionnaire.
Higher scores indicate stronger social connection and network engagement.
|
Assessed at enrollment and 6- and 12-weeks post-enrollment
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2031년 3월 1일
연구 완료 (추정된)
2031년 3월 1일
연구 등록 날짜
최초 제출
2026년 5월 13일
QC 기준을 충족하는 최초 제출
2026년 5월 13일
처음 게시됨 (실제)
2026년 5월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 1일
마지막으로 확인됨
2026년 9월 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. .