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

18. juni 2026 opdateret af: Dawn A. Goddard-Eckrich

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

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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

7

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Dawn A Goddard-Eckrich, EdD
  • Telefonnummer: 3-6601 212-853-6601
  • E-mail: dg2121@columbia.edu

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • New York
      • New York, New York, Forenede Stater, 10027
        • Columbia University School of Social Work
        • Kontakt:
      • Newburgh, New York, Forenede Stater, 12550

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Identify as a woman (cis-gender 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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Pre-Pilot WINGS+++ Intervention
Participants will receive the WINGS+++ 3-session mHealth intervention with peer navigation delivered over a 30-day period. Session 1 focuses on OUD/SUD screening, brief intervention, and referral to treatment (SBIRT) and includes a 40-minute mHealth tool plus a 20-minute peer navigator check-in. Session 2 focuses on IPV SBIRT and includes a 60-minute mHealth tool plus 20 minutes of peer navigation. Session 3 focuses on PTSD SBIRT and closing activities and includes a 60-minute mHealth tool plus 20 minutes of peer navigation. WINGS+++ mHealth sessions may be delivered using tablets at study sites or participant smartphones. Participants will also receive peer navigation from Community Health Advocates with lived experience of substance use disorder and/or intimate partner violence.
Adfærdsmæssigt: 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, harm reduction services, mental health services, and intimate partner violence services.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Score on the WINGS+++ Satisfaction Scale - Pre-Pilot Phase
Tidsramme: 1 month post-intervention
Acceptability will be measured using a study-specific 12-item satisfaction scale administered after the intervention. Each item is rated on a 4-point Likert scale from 1 (very unsatisfied) to 4 (very satisfied). A mean score is calculated across the 12 items, ranging from 1 to 4. Higher scores indicate greater acceptability.
1 month post-intervention

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Who Complete All 3 WINGS+++ Sessions - Pre-Pilot Phase
Tidsramme: 30 days per participant
Feasibility of intervention delivery will be assessed as the percentage of participants who complete all 3 WINGS+++ sessions. Higher percentages indicate greater feasibility.
30 days per participant
Number of Participants Who Complete the Post-Intervention Focus Group - Pre-Pilot Phase
Tidsramme: 1 month post intervention
Participant feedback to refine the intervention will be gathered through a post-intervention focus group workshop. Reported as the number of participants who complete the focus group.
1 month post intervention
Number of Key Stakeholders Who Complete the Survey and Interview - Group Pre-Pilot Phase
Tidsramme: 12 months
Key stakeholder input to inform pre-pilot refinement and pilot phase design will be gathered using the WINGS+++ Coalition and Key Stakeholder Survey (adapted from the HEALing Communities Study Community Coalition and Key Stakeholder Survey) and a qualitative interview. Reported as the number of stakeholders who complete both the survey and interview.
12 months
Mean Stakeholder Rating of WINGS+++ Acceptability and Feasibility Pre-Pilot
Tidsramme: 12 months
Key stakeholder and coalition input to inform pilot phase design will be assessed using the WINGS+++ Coalition and Key Stakeholder Survey, adapted from the HEALing Communities Study Community Coalition and Key Stakeholder Survey. Stakeholders rate items on 5-point Likert scales (e.g., 1 = Strongly Disagree to 5 = Strongly Agree; 1 = Very Dissatisfied to 5 = Very Satisfied), with mean scores ranging from 1 to 5. Higher scores indicate greater readiness, satisfaction, and support for implementing WINGS+++. Findings will be used to refine the intervention and study protocols for the subsequent pilot phase.
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dawn A. Goddard-Eckrich

Samarbejdspartnere

National Institute on Drug Abuse (NIDA)
University of Pennsylvania
City University of New York

Efterforskere

  • Studiestol: Louisa Gilbert, PhD, Columbia University
  • Studiestol: Nabila El-Bassel, PhD, Columbia University
  • Ledende efterforsker: Dawn A Goddard-Eckrich, EdD, Columbia University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juni 2026

Primær færdiggørelse (Anslået)

30. juli 2027

Studieafslutning (Anslået)

31. august 2027

Datoer for studieregistrering

Først indsendt

14. maj 2026

Først indsendt, der opfyldte QC-kriterier

18. juni 2026

Først opslået (Faktiske)

24. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AAAV9733
  • 1R61DA061375-01A1 (U.S. NIH-bevilling/kontrakt)

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Kliniske forsøg med Stof-relaterede lidelser

Kliniske forsøg med Pre-Pilot WINGS++++

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Sponsorer og samarbejdspartnere

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Betingelser

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Placeringer

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