Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

A Unique, Co-Designed Family-Based Therapy

8 de maio de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Abuso de opioides (distúrbio)

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

120

Estágio

Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Sandy Solove
Número de telefone: 614-247-8366
E-mail: solove.3@osu.edu

Locais de estudo

Estados Unidos
- Ohio
  - Columbus, Ohio, Estados Unidos, 43210
    - The Ohio State University
    - Contato:
      
      Sandy Solove
      
      Número de telefone: 614-247-8366
      
      E-mail: solove.3@osu.edu
    - Investigador principal:
      
      Aaron Murnan, PhD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Adulto
Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Finalidade Principal: Tratamento
Alocação: Randomizado
Modelo Intervencional: Atribuição Paralela
Mascaramento: Nenhum (rótulo aberto)

Número de braços

Armas e Intervenções

Grupo de Participantes / Braço	Intervenção / Tratamento
Experimental: 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.	Comportamental: 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. Comportamental: 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.
Comparador Ativo: 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.	Comportamental: 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.

Grupo de Participantes / Braço

Intervenção / Tratamento

Experimental: 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.

Comportamental: 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.

Comportamental: 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.

Comparador Ativo: 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.

Comportamental: Specialty Treatment Court Program Services

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Intervention Feasibility Prazo: 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 Prazo: 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

Medidas de resultados secundários

Medida de resultado	Descrição da medida	Prazo
Family Assessment Device (FAD-12) Prazo: 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 Prazo: 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) Prazo: 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) Prazo: 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.

Outras medidas de resultado

Medida de resultado	Descrição da medida	Prazo
Beck Depression Inventory (BDI) Prazo: 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) Prazo: 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 Prazo: 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) Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Ohio State University

Colaboradores

National Institute on Drug Abuse (NIDA)

Investigadores

Investigador principal: Aaron W Murnan, PhD, Ohio State University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

15 de junho de 2026

Conclusão Primária (Estimado)

28 de abril de 2028

Conclusão do estudo (Estimado)

28 de abril de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

1 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

8 de maio de 2026

Primeira postagem (Real)

14 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

8 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

20251206
K23DA058053 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Tipo de informação de suporte de compartilhamento de IPD

PROTOCOLO DE ESTUDO
SEIVA
CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Abuso de opioides (distúrbio)

Fondazione Policlinico Universitario Agostino Gemelli...

Ainda não está recrutando

Ultrassonografia Multiparamétrica para o Diagnóstico Não Invasivo da Doença Vascular Hepática Porto-sinusoidal (CEUS-PSVD)

Cirrose hepática | Hipertensão Portal Não Cirrótica | Hipertensão portal relacionada à cirrose | Elastografia Ultrassônica | Ultrassom com contraste | Porto-sinusoidal Vascular Liver Disorder

Itália

A Unique, Co-Designed Family-Based Therapy