A Unique, Co-Designed Family-Based Therapy
21 июля 2026 г. обновлено: 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.
Обзор исследования
Статус
Рекрутинг
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
120
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Sandy Solove
- Номер телефона: 614-247-8366
- Электронная почта: solove.3@osu.edu
Места учебы
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Ohio
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Columbus, Ohio, Соединенные Штаты, 43210
- Рекрутинг
- The Ohio State University
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Контакт:
- Sandy Solove
- Номер телефона: 614-247-8366
- Электронная почта: solove.3@osu.edu
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Главный следователь:
- Aaron Murnan, PhD
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Активный компаратор: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Intervention Feasibility
Временное ограничение: 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.
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up to 3 months post-intervention
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Client Satisfaction Questionnaire 8
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Family Assessment Device (FAD-12)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Beck Depression Inventory (BDI)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Aaron W Murnan, PhD, Ohio State University
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
14 июня 2026 г.
Первичное завершение (Оцененный)
28 апреля 2028 г.
Завершение исследования (Оцененный)
28 апреля 2028 г.
Даты регистрации исследования
Первый отправленный
1 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
8 мая 2026 г.
Первый опубликованный (Действительный)
14 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
22 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
21 июля 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 20251206
- K23DA058053 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .