A Unique, Co-Designed Family-Based Therapy
8 de mayo de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
120
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Sandy Solove
- Número de teléfono: 614-247-8366
- Correo electrónico: solove.3@osu.edu
Ubicaciones de estudio
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- The Ohio State University
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Contacto:
- Sandy Solove
- Número de teléfono: 614-247-8366
- Correo electrónico: solove.3@osu.edu
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Investigador principal:
- Aaron Murnan, PhD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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.
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.
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Comparador activo: 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.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intervention Feasibility
Periodo de tiempo: up to 3 months post-intervention
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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.
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up to 3 months post-intervention
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Client Satisfaction Questionnaire 8
Periodo de tiempo: up to 3 months post-intervention
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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.
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up to 3 months post-intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Family Assessment Device (FAD-12)
Periodo de tiempo: 1) Baseline and 2) up to 3 months post-intervention
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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.
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1) Baseline and 2) up to 3 months post-intervention
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Family Environment Scale
Periodo de tiempo: 1) Baseline and 2) up to 3 months post-intervention
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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.
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1) Baseline and 2) up to 3 months post-intervention
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Perceived Social Support - Family Assessment (PSS-FA)
Periodo de tiempo: 1) Baseline and 2) up to 3 months post-intervention.
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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.
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1) Baseline and 2) up to 3 months post-intervention.
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Addiction Severity Index (ASI)
Periodo de tiempo: 1) Baseline and 2) up to 3 months post intervention.
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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.
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1) Baseline and 2) up to 3 months post intervention.
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Beck Depression Inventory (BDI)
Periodo de tiempo: 1) Baseline and 2) up to 3 months post-intervention.
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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.
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1) Baseline and 2) up to 3 months post-intervention.
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Beck Anxiety Inventory (BAI)
Periodo de tiempo: 1) Baseline and 2) up to 3 months post-intervention.
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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.
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1) Baseline and 2) up to 3 months post-intervention.
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Specialty Treatment Court Program Engagement
Periodo de tiempo: Up to 3 months post-intervention.
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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.
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Up to 3 months post-intervention.
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Substance Use Stigma Mechanism Scale (SU-SMS)
Periodo de tiempo: 1) Baseline and 2) up to 3 months post-intervention.
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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.
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1) Baseline and 2) up to 3 months post-intervention.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Aaron W Murnan, PhD, Ohio State University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de junio de 2026
Finalización primaria (Estimado)
28 de abril de 2028
Finalización del estudio (Estimado)
28 de abril de 2028
Fechas de registro del estudio
Enviado por primera vez
1 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de mayo de 2026
Publicado por primera vez (Actual)
14 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20251206
- K23DA058053 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .