Pre-Pilot (R61) WINGS+++: mHealth to Improve MOUD Uptake in Women Experiencing Intimate Partner Violence and PTSD
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:
- Does WINGS+++ lower non-prescription opioid and other drug use in women?
- 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
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
New York
-
New York, New York, Yhdysvallat, 10027
- Columbia University School of Social Work
-
Newburgh, New York, Yhdysvallat, 12550
- Cornerstone
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- 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.
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Seulonta
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Mean Score on the WINGS+++ Satisfaction Scale - Pre-Pilot Phase
Aikaikkuna: 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
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Percentage of Participants Who Complete All 3 WINGS+++ Sessions - Pre-Pilot Phase
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 1 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.
|
1 months
|
|
Mean Stakeholder Rating of WINGS+++ Acceptability and Feasibility Pre-Pilot
Aikaikkuna: 1 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.
|
1 months
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Opintojen puheenjohtaja: Louisa Gilbert, PhD, Columbia University
- Opintojen puheenjohtaja: Nabila El-Bassel, PhD, Columbia University
- Päätutkija: Dawn A Goddard-Eckrich, EdD, Columbia University
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- AAAV9733
- 1R61DA061375-01A1 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .