이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

A Unique, Co-Designed Family-Based Therapy

2026년 5월 8일 업데이트: Ohio State University

A Unique, Co-Designed Family-Based Therapy for Women With Opioid Use Disorder and Justice-Involvement

The goal of this pilot trial is to evaluate the feasibility and acceptability of an adapted MDFT intervention with women who report prior OUD and sex trade involvement participating in specialty court treatment programs. The main question[s] the trial aims to answer are:

Will the inclusion of the adapted MDFT intervention be feasible among the target population?
Will participant dyads assigned to the adapted intervention perceive the intervention as acceptable and beneficial?

Participants will be randomly assigned to receive either: 1) the adapted MDFT + TAU; or 2) TAU. Participants will complete baseline and post-intervention assessments.

연구 개요

상태

아직 모집하지 않음

정황

오피오이드 남용(장애)

개입 / 치료

상세 설명

Given well-documented risks associated with the sex trade and opioid use, as well as a lack of interventions prospectively designed to address challenges experienced by this population, the current study represents a critical next step towards promoting the health and well-being of women who use opioids and engage in the sex trade. The current study aims to evaluate the feasibility and acceptability of co-designed, adapted family intervention offered as an adjunct to specialty treatment court programming (offered through the criminal justice system) using a pilot RCT design. Family dyads (n=60 dyads; 120 individuals) comprised of one specialty treatment court participant and one family member selected by the treatment participant will be recruited to participate in a randomized controlled trial. Participant dyads will be randomly assigned to one of two treatment arms: 1) co-designed, adapted family intervention + specialty treatment court programming or 2) specialty treatment court programming only. The primary outcomes for this pilot trial are the feasibility and acceptability of the co-designed, adapted family intervention. Preliminary efficacy for outcomes of interest will also be explored; however the current study is not powered to detect effects given the small sample size. The current study moves the field forward by pilot testing an evidence-based family intervention that has been adapted through co-design methodologies to be highly responsive to the unique needs of specialty treatment court participants.

연구 유형

중재적

등록 (추정된)

120

단계

해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Sandy Solove
전화번호: 614-247-8366
이메일: solove.3@osu.edu

연구 장소

미국
- Ohio
  - Columbus, Ohio, 미국, 43210
    - The Ohio State University
    - 연락하다:
      
      Sandy Solove
      
      전화번호: 614-247-8366
      
      이메일: solove.3@osu.edu
    - 수석 연구원:
      
      Aaron Murnan, PhD

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 for Specialty Treatment Court Participants:

18 years of age or older
Identify as a woman
meet or have met DSM5 criteria for an Opioid Use Disorder (OUD)
report current or prior sex trade involvement
attending a specialty treatment court / treatment diversion program
Identify one family member able to participate

Inclusion Criteria for Family Participants

18 years of age or older
Willing to participate in a hypothetical family intervention

Exclusion Criteria for Specialty Treatment Court Participants:

Under age 18
Non-English speaking

Exclusion Criteria for Family Participants:

Under age 18
Non-English Speaking

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: 무작위
중재 모델: 병렬 할당
마스킹: 없음(오픈 라벨)

팔의 수

무기와 개입

참가자 그룹 / 팔	개입 / 치료
실험적: Adapted MDFT + TAU Participant dyads in this arm will receive up to 20 sessions of the adapted Multi-Dimensional Family Therapy (MDFT) intervention in addition to services received as part of their treatment as usual (TAU) received as part of their specialty treatment court program.	행동: Adapted Multi-Dimensional Family Therapy The adapted MDFT will be delivered during a 12 week period (max of 20 sessions). The adapted MDFT seeks to support reductions in opioid use by targeting improvements in family factors (e.g. family conflict/stress, support, functioning, and familial substance use) that relate closely to substance use and treatment outcomes. Participant dyads come together to navigate and problem-solve family-level challenges. In session, participants will learn new ways to communicate, receive support to mend damaged relationships, build trust, and ultimately develop new strategies of supporting one another's needs with emphasis on supporting women's reductions in substance use. Interventionists work with family dyads to address problems underlying familial stress, conflict, and low support as they arise. Successful strategies to navigate these challenges in session are then translated to outside of sessions to promote self-sustaining changes within families. 행동: Specialty Treatment Court Program Services Specialty Treatment Court services include individual and group therapy sessions focused on substance use and mental health, case management, and wrap-around services related to housing and basic needs.
활성 비교기: Treatment As Uusual This arm receives the normal services offered through the specialty court treatment program they are currently enrolled in. This typically includes individual and group therapy sessions focused on substance use and mental health, case management, and wrap-around services related to housing and basic needs.	행동: Specialty Treatment Court Program Services Specialty Treatment Court services include individual and group therapy sessions focused on substance use and mental health, case management, and wrap-around services related to housing and basic needs.

참가자 그룹 / 팔

개입 / 치료

실험적: Adapted MDFT + TAU

Participant dyads in this arm will receive up to 20 sessions of the adapted Multi-Dimensional Family Therapy (MDFT) intervention in addition to services received as part of their treatment as usual (TAU) received as part of their specialty treatment court program.

행동: Adapted Multi-Dimensional Family Therapy

The adapted MDFT will be delivered during a 12 week period (max of 20 sessions). The adapted MDFT seeks to support reductions in opioid use by targeting improvements in family factors (e.g. family conflict/stress, support, functioning, and familial substance use) that relate closely to substance use and treatment outcomes. Participant dyads come together to navigate and problem-solve family-level challenges. In session, participants will learn new ways to communicate, receive support to mend damaged relationships, build trust, and ultimately develop new strategies of supporting one another's needs with emphasis on supporting women's reductions in substance use. Interventionists work with family dyads to address problems underlying familial stress, conflict, and low support as they arise. Successful strategies to navigate these challenges in session are then translated to outside of sessions to promote self-sustaining changes within families.

행동: Specialty Treatment Court Program Services

Specialty Treatment Court services include individual and group therapy sessions focused on substance use and mental health, case management, and wrap-around services related to housing and basic needs.

활성 비교기: Treatment As Uusual

This arm receives the normal services offered through the specialty court treatment program they are currently enrolled in. This typically includes individual and group therapy sessions focused on substance use and mental health, case management, and wrap-around services related to housing and basic needs.

행동: Specialty Treatment Court Program Services

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Intervention Feasibility 기간: up to 3 months post-intervention	Feasibility will be assessed using rates of intervention engagement/utilization, among participating dyads. Intervention engagement will be measured by the number of sessions attended by participants assigned to the adapted MDFT intervention. Number of sessions utilized will range from 0-20, a higher number of sessions utilized will reflect better treatment engagement. Participants who receive 4 or more sessions will be considered to have engaged in the intervention.	up to 3 months post-intervention
Client Satisfaction Questionnaire 8 기간: up to 3 months post-intervention	The CSQ-8 consists of 8 questions that assess intervention recipient's satisfaction with the intervention they received. The questions are scored on 4-point Likert scales, range of scores is 1-32 with higher scores reflecting higher satisfaction with the intervention.	up to 3 months post-intervention

2차 결과 측정

결과 측정	측정값 설명	기간
Family Assessment Device (FAD-12) 기간: 1) Baseline and 2) up to 3 months post-intervention	The Family Assessment Device will be administered to all participants and will yield data on various domains of family functioning across the family system. The FAD-12, is a 12 self-report item measure that yields psychometrically validated subscale scores for: Involvement; responsiveness; behavioral control; communication; problem solving; and roles, which generates a psychometrically supported composite score for family functioning. Questions are scored on a Likert Scale (1-4) with lower scores reflecting better family functioning and better outcomes. Range of scores is 12-48.	1) Baseline and 2) up to 3 months post-intervention
Family Environment Scale 기간: 1) Baseline and 2) up to 3 months post-intervention	The Family Environment Scale will yield scores for family conflict, cohesion, expressiveness, and quality of family relationships. It will be administered to all participants as part of the pre and post-intervention assessment battery. This measure uses True/False questions about participant's family environment to generate psychometrically validated scores for family conflict, cohesion, and quality of family relationships. Raw total scores range from 0-90. Results are interpreted by comparing individual raw scores to established normative reference ranges, typically expressed as standard T-scores with a mean of 50 and a standard deviation of 10. Scores above or below 1 standard deviation from the mean suggest significant deviation in family dimensions. Therefore higher scores suggest worse family environments and worse outcomes.	1) Baseline and 2) up to 3 months post-intervention
Perceived Social Support - Family Assessment (PSS-FA) 기간: 1) Baseline and 2) up to 3 months post-intervention.	The Perceived Social Support - Family Assessment (PSS-FA) will be administered to assess family support at each time point. The PSS-FA includes 20 self-report items (Yes[1]/No[0]) that yield a psychometrically validated subscale score for Family Support (range: 0-20), with higher scores reflecting higher levels of perceived support and better outcomes.	1) Baseline and 2) up to 3 months post-intervention.
Addiction Severity Index (ASI) 기간: 1) Baseline and 2) up to 3 months post intervention.	Addiction Severity Index will be used to assess substance use among participants at both timepoints. ASI is a clinical/research instrument. Participants will be asked to answer questions related to the last 30 days including: days in treatment and days using various substances. Increased number of days (0-30) of reported substance use will reflect worse substance use.	1) Baseline and 2) up to 3 months post intervention.

기타 결과 측정

결과 측정	측정값 설명	기간
Beck Depression Inventory (BDI) 기간: 1) Baseline and 2) up to 3 months post-intervention.	Beck Depression Inventory will be used to assess depressive symptoms among women and their family supports at both timepoints. The BDI is a 21 question, self-report measure containing 21 Likert scale response questions (0-3), with higher scores reflecting worse depressive symptoms and outcomes. Range of scores is 0-63.	1) Baseline and 2) up to 3 months post-intervention.
Beck Anxiety Inventory (BAI) 기간: 1) Baseline and 2) up to 3 months post-intervention.	Beck Anxiety Inventory will be used to assess anxiety symptoms among women and their family supports at both timepoints. The BAI includes 21 self-report items measured on a Likert scale (0-3), with higher scores reflecting worse anxiety symptoms and outcomes. Range of scores is 0-63.	1) Baseline and 2) up to 3 months post-intervention.
Specialty Treatment Court Program Engagement 기간: Up to 3 months post-intervention.	Details related to substance use treatment services received, mental health services received, and continuation of specialty court treatment programming will be monitored. Engagement in specialty treatment court program will be assessed via lower rates of specialty court drop-out and higher service utilization. Specifically, participants who utilize more services and who do not drop out of the program will be considered to being engaging more in their existing specialty treatment court programming.	Up to 3 months post-intervention.
Substance Use Stigma Mechanism Scale (SU-SMS) 기간: 1) Baseline and 2) up to 3 months post-intervention.	The Substance Use Stigma Mechanism Scale (SU-SMS) will yield scores for perceived and experienced stigma related to substance use and substance use treatment. It will be administered to participants as post of the pre and post-intervention assessment battery. The measure uses 5-point Likert Scale questions to generate psychometrically validated scores for perceived stigma experienced. Scores range from 0-90 with higher scores reflecting more perceived stigma experienced.	1) Baseline and 2) up to 3 months post-intervention.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Ohio State University

협력자

National Institute on Drug Abuse (NIDA)

수사관

수석 연구원: Aaron W Murnan, PhD, Ohio State 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 (추정된)

2026년 6월 15일

기본 완료 (추정된)

2028년 4월 28일

연구 완료 (추정된)

2028년 4월 28일

연구 등록 날짜

최초 제출

2026년 5월 1일

QC 기준을 충족하는 최초 제출

2026년 5월 8일

처음 게시됨 (실제)

2026년 5월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 8일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

20251206
K23DA058053 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 공유 지원 정보 유형

연구_프로토콜
수액
ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

Adapted Multi-Dimensional Family Therapy에 대한 임상 시험

Training and Implementation Associates

모병

FTTIP(Family Therapy Training and Implementation Platform): 장기 진료 개선을 위한 혁신적인 웹 기반 도구

전통적인 대면 교육 | FTTIP(가족 치료 교육 및 구현 플랫폼)

미국

A Unique, Co-Designed Family-Based Therapy