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Идёт набор NCT07587359

A Unique, Co-Designed Family-Based Therapy

Без фазы С лечением Opioid Abuse (Disorder)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Adapted Multi-Dimensional Family Therapy, Specialty Treatment Court Program Services.
Кому может быть актуально
Состояния в реестре: Opioid Abuse (Disorder). Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое 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 dam
  • Поведенческое 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.

Первичные конечные точки

  • Intervention Feasibility [Срок оценки: up to 3 months post-intervention]
  • Client Satisfaction Questionnaire 8 [Срок оценки: up to 3 months post-intervention]
Вторичные конечные точки (4)
  • Family Assessment Device (FAD-12) [Срок оценки: 1) Baseline and 2) up to 3 months post-intervention]
  • Family Environment Scale [Срок оценки: 1) Baseline and 2) up to 3 months post-intervention]
  • Perceived Social Support - Family Assessment (PSS-FA) [Срок оценки: 1) Baseline and 2) up to 3 months post-intervention.]
  • Addiction Severity Index (ASI) [Срок оценки: 1) Baseline and 2) up to 3 months post intervention.]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • The Ohio State University — Columbus

Идентификаторы

NCT: NCT07587359 · 20251206 · K23DA058053

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗