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A Unique, Co-Designed Family-Based Therapy

8 maja 2026 zaktualizowane przez: 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:

  1. Will the inclusion of the adapted MDFT intervention be feasible among the target population?
  2. 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

120

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Stany Zjednoczone
    • Ohio
      • Columbus, Ohio, Stany Zjednoczone, 43210
        • The Ohio State University
        • Kontakt:
        • Główny śledczy:
          • Aaron Murnan, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: 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.
Behawioralne: 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.
Aktywny komparator: 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.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Intervention Feasibility
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Family Assessment Device (FAD-12)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Beck Depression Inventory (BDI)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Ohio State University

Współpracownicy

National Institute on Drug Abuse (NIDA)

Śledczy

  • Główny śledczy: Aaron W Murnan, PhD, Ohio State University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 czerwca 2026

Zakończenie podstawowe (Szacowany)

28 kwietnia 2028

Ukończenie studiów (Szacowany)

28 kwietnia 2028

Daty rejestracji na studia

Pierwszy przesłany

1 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 maja 2026

Pierwszy wysłany (Rzeczywisty)

14 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

14 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 20251206
  • K23DA058053 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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