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Набор скоро начнётся NCT07579299

Engaging Family Members During Early SUD Treatment: A Hybrid Trial

Без фазы С лечением Substance Use Disorder (SUD)

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: Engagement Strategy 1, Engagement Strategy 2, Engagement Strategy 3, Engagement Strategy 4.
Кому может быть актуально
Состояния в реестре: Substance Use Disorder (SUD). Базовые параметры: от 18 лет · Все.
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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Обзор

The goal of this study is a fractional factorial optimization trial to optimize engagement in a CRAFT program for family members with loved ones in outpatient treatment for a substance use disorder. This study aims to identify family engagement strategies that are feasible, acceptable, and appropriate and effective in increasing family member initiation with CRAFT. Participants will complete an iterative, online process where they will evaluate and rank different engagement strategies to identify the most optimal in increasing engagement and then participate in an optimization trial to identify which strategies were most effective in increasing family member engagement.

Подробное описание

Family members (FMs) of people with substance use disorder (SUD)-including biological, extended, or chosen family-face chronic stress and are at high risk for mental and physical health problems. The impact is worsened by stigma, guilt, shame, and self-blame that often accompany a loved one's substance use, leading to social isolation and uncertainty about how to support recovery. Although FMs are motivated to help with treatment navigation, many do not seek support for themselves. Programs like Community Reinforcement and Family Training (CRAFT) can support FMs and provide tools to improve their own lives while assisting their loved one's recovery. While CRAFT is well-established in community settings for increasing a family member's initiation into treatment, its applicability in clinical SUD settings is less clear. It remains unknown whether CRAFT can enhance patient treatment retention in clinical settings and whether FMs who might not seek care would participate.

To advance the science of engaging and supporting families impacted by SUD, investigators will (1) Conduct an iterative online process with FMs and clinic staff to identify potential family engagement strategies that community health centers (CHCs) can deliver that are effective, feasible, acceptable, and appropriate, and (2) Test those strategies using a fractional factorial trial.

Вмешательства

  • Поведенческое Engagement Strategy 1
    Engagement Strategy
  • Поведенческое Engagement Strategy 2
    Engagement Strategy
  • Поведенческое Engagement Strategy 3
    Engagement Strategy
  • Поведенческое Engagement Strategy 4
    Engagement Strategy
  • Поведенческое Placebo
    No engagement strategies

Первичные конечные точки

  • Attendance [Срок оценки: 2 months after baseline]
Вторичные конечные точки (3)
  • Feasibility of Engagement Strategies [Срок оценки: 6 months from enrollment]
  • Acceptability of Engagement Strategies [Срок оценки: 6 months from enrollment]
  • Appropriateness of Engagement Strategies [Срок оценки: 6 months from enrollment]

Критерии участия

FAMILY MEMBERS:

Критерии включения

  • 18 years old or older
  • A parent, child, sibling, spouse/romantic partner, or other adult supporting a loved one who initiated SUD treatment in past 3 months
  • Cohabitating with their loved one
  • In frequent contact (in-person or virtual) with their loved one (at least 3x/week)
  • Not worried about potential physical harm from their loved one
  • Report no illicit drug use in the past year

PATIENTS:

Критерии включения

  • 18 years old or older
  • In frequent contact with a family member (at least 3x/week) that they cohabitate with
  • Have initiated substance use treatment in past 3 months

CLINIC PROVIDERS:

Критерии включения

  • Counselor/Clinician providing care at our partner clinic for SUD

Exclusion Criteria (ALL):

  • Does not have capacity to consent (e.g., severe cognitive impairment, in active psychosis, or developmental disabilities)
  • Does not understand English fluently

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Family Health Centers of San Diego — San Diego

Идентификаторы

NCT: NCT07579299 · IRB-86357 · 1R61DA064789-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗