Pre-Pilot (R61) WINGS+++: mHealth to Improve MOUD Uptake in Women Experiencing Intimate Partner Violence and PTSD

Официальное название

Pre-Pilot WINGS +++ An Effectiveness Trial of Syndemic Mhealth Intervention to Increase MOUD Uptake Among Women Impacted by Intimate Partner Violence and PTSD.

Обзор

The goal of this pre-pilot for the clinical trial is to develop a mobile health (mHealth) program called WINGS+++ can help women with opioid use disorder or other substance use disorders who have experienced intimate partner violence. The pre-pilot study will take place in Orange County, New York with n=7 women. . The main questions it aims to answer are: 1. Does WINGS+++ lower non-prescription opioid and other drug use in women? 2. Does WINGS+++ help connect women to treatment for substance use, intimate partner violence, and post-traumatic stress disorder (PTSD)? Researchers will compare WINGS+++ to standard care to see if WINGS+++ works better to lower drug use and link women to helpful services. WINGS+++ is a 3-session program on a mobile device that: * Screens for intimate partner violence, PTSD, and substance use * Offers brief support and referrals based on each woman's needs and preferences * Connects women to a peer navigator who helps link them to services Participants will: * Take part in only the WINGS+++ program for the pre-pilot * Answer survey questions about drug use, intimate partner violence, and PTSD symptoms * Provide biological samples (such as urine or hair) to check for drug use * Share information about the services they have used

Подробное описание

The goal of this pre-pilot for the clinical trial is to develop a mobile health (mHealth) program called WINGS+++ that can help women with opioid use disorder or other substance use disorders who have experienced intimate partner violence. The pre-pilot study will take place in Orange County, New York with n=7 women.

WINGS+++ is delivered across 3 sessions on a mobile device and combines three components into a single program: a tool that screens for physical, sexual, and emotional abuse and provides brief support and safety planning; a tool that identifies trauma-related (PTSD) symptoms and offers brief education and coping strategies; and a tool that screens for substance use concerns and helps connect women to appropriate treatment. The program also includes peer navigators, trained individuals with lived experience of substance use, intimate partner violence, or both who help connect participants to services based on their screening results and preferences.

This pre-pilot is a single-arm study in which all participants receive WINGS+++. The main goals are to assess whether the program and study procedures are feasible, acceptable to participants, and safe. Feasibility will be measured through factors such as recruitment, retention, session completion, and successful connection to referred services. Acceptability will be assessed through participant feedback, including interviews about their experience. Safety will be monitored by tracking any adverse events. Findings will be used to refine the program before later phases of the study.

Вмешательства

• Поведенческое Pre-Pilot WINGS++++
  Pre-Pilot WINGS+++ Intervention (3 sessions) After completing the baseline survey, they will participate in the three-session WINGS+++ program using a tablet, computer, or smartphone. The sessions include educational videos, interactive exercises, safety planning tools, and activities designed to address intimate partner violence, trauma symptoms, and substance use. Work with a Community Health Advocate (Peer Navigator) who will help set goals and connect you to services such as MOUD treatment,

Первичные конечные точки

• Mean Score on the WINGS+++ Satisfaction Scale - Pre-Pilot Phase [Срок оценки: 1 month post-intervention]

Критерии участия

Критерии включения

• Identify as a woman (cisgender or transgender)
• Aged 18 or older
• Report use of non-prescribed opioids in the past 30 days
• Score positive for risk of opioid use disorder or other substance use disorder on the Drug Abuse Screening Test (DAST) with a cut-off score of 6 or higher
• Report experiencing any severe psychological abuse or any physical or sexual abuse by a female or male intimate partner in the past year.

Критерии исключения

• Evidence of significant psychiatric or cognitive impairment that would limit effective participation, as confirmed during informed consent;
• Inability to speak and understand English sufficiently to participate in assessments or intervention sessions.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 2 центра

• Columbia University School of Social Work — New York
• Cornerstone — Newburgh

Идентификаторы

NCT: NCT07665502 · AAAV9733 · 1R61DA061375-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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