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| ID | Type | Description | Link |
|---|---|---|---|
| 1R61DA061375-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| City University of New York | OTHER |
| University of Pennsylvania | OTHER |
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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:
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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Pilot WINGS+++ Intervention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-Pilot WINGS++++ | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Score on the WINGS+++ Satisfaction Scale - Pre-Pilot Phase | 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Complete All 3 WINGS+++ Sessions - Pre-Pilot Phase | 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 |
Inclusion Criteria:
Exclusion Criteria:
Identify as female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dawn A Goddard-Eckrich, EdD | Contact | 212-853-6601 | 3-6601 | dg2121@columbia.edu |
| Cathy Pak, MPH | Contact | 212-853-6601 | 3-6601 | chp2102@columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Louisa Gilbert, PhD | Columbia University | Study Chair |
| Nabila El-Bassel, PhD | Columbia University | Study Chair |
| Dawn A Goddard-Eckrich, EdD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University School of Social Work | New York | New York | 10027 | United States |
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The R61 pre-pilot phase is a single-arm pilot trial evaluating the feasibility, acceptability, and safety of WINGS+++ and assessing pre- to post-intervention changes in primary and secondary outcomes. 7 women with opioid use disorder or other substance use disorder who have experienced intimate partner violence in the past year will be enrolled from two harm reduction programs in Orange County, New York. All participants receive WINGS+++, a 3-session mHealth intervention integrating an IPV screening, brief intervention, and referral (SBIRT) tool, a novel PTSD SBIRT tool, and an OUD/SUD SBIRT with a service linkage platform (NYMatters), delivered alongside peer navigation. Assessments occur at baseline and 1-months post-intervention. Findings will inform refinement of WINGS+++ and the implementation infrastructure for the R61 pilot phase and the subsequent R33 effectiveness trial.
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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 | 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 | 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 |
| Columbia University |
| Principal Investigator |
| Cornerstone | Newburgh | New York | 12550 | United States |
|
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D019966 | Substance-Related Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D003130 | Combat Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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