CClinicalTrials.gg
Not yet recruitingNCT07775677Updated Aug 20, 2026

IPV Prevention Among FDP

An interventional study of EA$E-US and ongoing standard of care in PTSD Symptoms, Violence Prevention and Depression and Anxiety Symptoms, sponsored by George Mason University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by George Mason University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
107
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Forcibly displaced women and their male partners experience compounding social and structural vulnerabilities to intimate partner violence (IPV) and mental health challenges, yet rigorous studies or examples of evidence-based interventions that seek to prevent and reduce IPV and mental health problems among forcibly displaced populations (FDPs) who seek asylum and rebuild their lives in the United States (US) are scarce. Guided by the the Assessment, Decision, Adaptation, Production, Topical experts-integration, Training, and Testing (ADAPT-ITT) framework, Cascade Implementation Framework, and NIMH experimental therapeutics approach, we propose to address this gap in research and practice by (1) adapting the Economic and Social Empowerment (EA$E) curriculum for US-based FD Congolese couples, (2) using a hybrid type 2 pilot study design to explore preliminary effects of EA$E-US on IPV, mental health outcomes and intermediary outcomes, and (3) examining implementation processes and outcomes

Read the detailed description

Exposure to war, persecution, and forced migration put FDPs at disproportionately high risk for IPV and mental health problems. Many FD women arrive from countries where IPV is prevalent, and face increased risk before, during, and after displacement. Foreign-born women who experience IPV are more likely to be severely injured or killed, and report worse mental health than US-born women. Financial and social stressors, and persistent sex-based inequities in the US can exacerbate both IPV and poor mental health outcomes among FDPs. Yet, US-based programs primarily focus on connecting survivors to services once IPV occurs, overlooking strategic opportunities to prevent IPV and poor mental health among FDPs. In contrast to the US context, there is a rapidly evolving evidence-base of interventions developed globally that show promise in reducing IPV among FDPs. The EA$E intervention (developed by IRC and MPI Wachter) has been shown to reduce IPV and post-traumatic stress disorder (PTSD) symptoms in a randomized controlled trial (RCT) conducted in West Africa led by MPI Gupta. The International Rescue Committee (IRC), a global humanitarian organization, developed EA$E to address two underlying drivers of IPV in crisis settings--household financial strain and sex-based inequity in decision-making--innovatively diminishing risk factors associated with IPV. EA$E addresses IPV at the individual and interpersonal levels by leading couples engaged in economic activities through an 8-session discussion series on household financial wellbeing, budgeting, spousal communication, and alternatives to violence. US-based programs for FDPs are in need of evidence-based curricula to address IPV and mental health. Our overall objective is to advance the nascent science of IPV prevention among FDPs in the US. Our interdisciplinary team (public health, social work, and clinical psychology) is uniquely positioned to conduct the proposed study based on our combined expertise in IPV and mental health research and practice with FDPs across settings and longstanding partnership with the IRC. Guided by the ADAPT-ITT framework, Cascade Implementation Framework, and the NIMH experimental therapeutics approach, we will develop EA$E-US, examine preliminary effectiveness on intervention and intermediary outcomes, and assess implementation outcomes via a hybrid type 2 pilot study design.

02

Conditions studied

  • PTSD Symptoms
  • Violence Prevention
  • Depression and Anxiety Symptoms

Keywords

  • violence prevention
  • implementation research
  • mental health
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • couples who are:

    • 18 years or older
    • Married or in a relationship and currently living with your spouse / partner
    • Came to the U.S. within the past 5 years
    • Originally from the Democratic Republic of Congo
    • Fluent in Kinyarwanda, Kinyamulenge, and/or Kinyabwisha
    • Current or past client of the International Rescue Committee

Exclusion criteria

Exclusion Criteria:

  • 1) not fluent in Kinyarwanda, Kinyamulenge or Kinyabwisha, 2) people who are currently seeking legal protection against an abusive partner and/or are engaged in IRC provided case management services for IPV.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
107 participants (estimated)

Study arms

  • Other
    Standard of care (ongoing economic programming)

    Standard of care, receive ongoing IRC provided services, including economic empowerment services (job training, financial coaching, etc).

    Other: ongoing standard of care

  • Experimental
    EA$E-US

    Couples randomized to this arm will receive the EA$E-US intervention. This is an 8-session curriculum focusing on communication, healthy communication, conflict resolution, joint decision-making, and coping.

    Behavioral: EA$E-US

Interventions

  • BehavioralEA$E-US

    Couples randomized to this arm will receive the EA$E-US intervention. This is an 8-session curriculum focusing on communication, healthy communication, conflict resolution, joint decision-making, and coping.

  • Otherongoing standard of care

    Ongoing services offered by IRC including job training, financial coaching and budgeting, and assistance.

05

What researchers measure

Primary outcomes

  1. Change in past month anxiety symptoms assessed by GAD-7 at 5 months

    Generalized Anxiety Disorder 7; 7 items. Scores range from 0 to 21, with higher values indicating greater symptom severity.

    Time frame: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)

  2. Change in depressive symptoms assessed by PHQ-9 at 5 months

    Patient health questionnaire-9; 9 items; values range from 0 to 27 with higher values indicating greater depressive symptom severity

    Time frame: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)

  3. Change in past month PTSD Symptoms assessed by PTSD checklist at 5 months

    Post traumatic disorder checklist -5. This is a 20 item scale with values ranging from 0 to 80. With higher values indicating greater symptom severity

    Time frame: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)

  4. Change in Past month experiences of physical intimate partner violence assessed by WHO Physical violence subscale at 5 months.

    World Health Organization's Physical Violence subscale. The 6-item subscale assesses participants' experiences of six specific acts of physical violence perpetrated by an intimate partner. Scores range from 0 (zero acts) to 6 (multiple acts), representing the number of different physical IPV acts experienced, with higher scores indicating greater exposure to physical IPV.

    Time frame: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)

  5. Change in past month experiences of emotional intimate partner violence assessed by WHO's emotional violence subscale at 5 months.

    World Health Organization's Emotional Violence subscale. The 4--item subscale assesses participants' experiences of four specific acts of emotional violence perpetrated by an intimate partner. Scores range from 0 (zero acts) to 4 (multiple acts), representing the number of different emotional IPV acts experienced, with higher scores indicating greater exposure to emotional IPV.

    Time frame: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)

  6. Change in past month experiences of Economic intimate partner violence assessed by an economic subscale initially created for the original EA$E RCT in Côte d'Ivoire at 5 months.

    The economic subscale was initially created for the original EA$E RCT in Côte d'Ivoire. The 4-item subscale assesses participants' experiences of four specific acts of economic violence perpetrated by an intimate partner. Scores range from 0 (zero act) to 4 (multiple acts), representing the number of different economic IPV acts experienced, with higher scores indicating greater exposure to economic IPV.

    Time frame: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)

  7. Change in past month economic coercion assessed by ECS-20 at 5 months.

    Economic Coercion Scale-20 (ECS-20). The ECS-20 is a short form version of the economic coercion scale-36). The 20 item scale assesses 1) participants' experiences of 20 specific acts of economic coercion by an intimate partner in their lifetime; and 2) the frequency of each act during the past month for those acts reported as having occurred at least once during the participant's lifetime. Scores range from 0 (zero acts) to 20 (multiple acts) with higher scores indicating greater economic coercion.

    Time frame: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)

  8. Change in past month experiences of controlling behaviors assessed by DHS controlling behaviors subscale in 5 months.

    Demographic and Health Surveys (DHS) Controlling Behaviors scale. The 6-item scale assesses participants' experiences of six specific acts of controlling behaviors perpetrated by an intimate partner. Scores range from 0 (zero acts) to 6 (multiple acts), representing the number of different acts of controlling behavior experienced, with higher scores indicating greater exposure to controlling behaviors.

    Time frame: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)

Secondary outcomes

  1. Change in past month Intimate partner violence acceptance assessed by DHS attitudes towards wife-beating scale at 5 months.

    Demographic and Health Surveys (DHS) Attitudes Towards Wife-Beating Scale. The 6-item scale assesses participants' beliefs of five specific attitudes toward intimate partner violence against wives perpetrated by an intimate partner. Scores range from 0 (zero beliefs) to 6 (multiple beliefs), representing the number of beliefs held, with higher scores indicating greater acceptance toward intimate partner violence against wives.

    Time frame: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)

  2. Change in gender equitable attitudes assessed by GEM scale at 5 months.

    A modified version of the Gender equitable attitudes (GEM) scale. This modified version is a 13 item scale that assesses participants' gender equitable attitudes across three domains: 1) Domestic Chores \& Daily Life; 2) Reproductive Health and Disease; and 3) Prevention Domain Violence. The Sexual relationship domain items were removed for this population. Response options include agree = 1; partially agree = 2; and disagree = 3. Scores range from 13 to 39, with higher scores indicating greater inequitable gender attitudes.

    Time frame: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)

  3. Change in coping behaviors assessed by Brief COPE, Religion subscale at 5 months.

    Brief COPE, Religion Subscale. This is a two item scale used to assess engagement in religious and spiritual coping. Scores range from 0-3, with higher scores indicating greater engagement in religious and/or spiritual coping mechanisms.

    Time frame: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)

  4. Change in coping Self-efficacy assessed by the coping self-efficacy scale at 5 months.

    The coping self-efficacy scale is a 13 item scale used to assess coping self-efficacy. Scores range from 0 to 10, with higher scores indicating greater self-efficacy.

    Time frame: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)

  5. Change in level of Social Support assessed by ESSI at 5 months.

    The ENRICHD Social Support Inventory (ESSI). The ESSI is a 5 item used to assess level of social support. Scores range from 5 to 15 with higher scores indicated greater social support.

    Time frame: (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)

  6. Change in Household Decision Making involvement assessed by DHS women's autonomy in household decision making scale at 5 months.

    A modified version of the Demographic and Health Surveys (DHS) Women's autonomy in household decision making scale. The questions were slightly adapted for the study population and an additional question was added. This is a 4 item scale used to assess the number of decisions a women is involved in regarding household decision making. Scores range from 0-3 with higher scores indicating a greater number of decisions the wife/partner is involved in.

    Time frame: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)

  7. Change in Family Functioning assessed by the feminist grounded family functioning scale at 5 months.

    Feminist Grounded Family Functioning Scale. This is a 26 item scale used to assess family functioning. Scores range from 1-4 with higher scores indicating greater family functioning.

    Time frame: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)

  8. Change in Spousal relationship communication assessed by CFAT communication subscale at 5 months.

    Couple functionality assessment tool (CFAT) communication subscale. This is a 7 item scale used to assess spousal relationship communication. Scores range from 7-21 with higher scores indicating greater relationship communication between spouses.

    Time frame: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)

Other outcomes

  1. Facilitator's perception of intervention session feasibility assessed by Weiner feasibility subscale after each session (weekly for 2 months).

    feasibility will be measured via the Weiner feasibility scale. This 4 item scale will assess the extent to which a facilitator perceives that it is feasible that they can facilitate each individual EA$E-US session. Scores range from 4 to 20, with higher scores indicating greater levels of perceived feasibility.

    Time frame: T2 (8 weeks from baseline) for each session (weekly for two months).

  2. Facilitator perception of intervention session Acceptability assessed by Weiner Acceptability scale after each session (weekly for 2 months).

    Acceptability will be measured via the Weiner acceptability scale. This 4 item scale will assess the extent to which a facilitator perceives that each individual EA$E-US session is acceptable for IRC and their community. Scores range from 4 to 20, with higher scores indicating greater levels of perceived acceptability.

    Time frame: T2 (8 weeks from baseline) for each session (weekly for two months).

  3. Facilitators perceptions of intervention session Appropriateness assessed by Weiner appropriateness scale after each session (weekly for 2 months).

    Appropriateness will be measured via the Weiner Appropriateness scale. This 4 item scale will assess the extent to which a facilitator perceives that each individual EA$E-US session is Appropriateness for IRC and their community. Scores range from 4 to 20, with higher scores indicating greater levels of perceived Appropriateness.

    Time frame: T2 (8 weeks from baseline) for each session (weekly for two months).

  4. Microadaptations made during each intervention session (weekly for two months)

    microadaptations will be assessed by documenting the type, frequency, and reasons for planned and spontaneous modifications through field notes and facilitator feedback sessions.

    Time frame: T2 (8 weeks from baseline) for each session (weekly for two months).

  5. Couple's Attendance for each session (weekly for two months)

    Attendance will be documented with an attendance tracking sheet that assess whether participants attended each session, late arrival time, and time left early. Attendance will be assessed by the Proportion of enrolled couples who attended at least 75% of EA$E-US sessions (6 sessions out of 8)

    Time frame: T2 (8 weeks from baseline) for each session (weekly for two months).

  6. Change in Perceived Safety assessed by Researcher-created items and open-ended questions weekly for two months and at 5 months.

    Perceived safety will be measured via Researcher-created items and open-ended questions to probe perceptions of participant and facilitator safety. And the Perception of threats to personal safety associated with participating in the intervention, 1-item (Female participants)

    Time frame: Baseline (T1), T2 (immediately after intervention, 8 weeks from baseline), and T3 (5 months after baseline)

  7. Intervention Fidelity (overall and by session) assessed by a fidelity checklist at each session (weekly for two months)

    A fidelity checklist will be created based on instructions in the adapted EA$E-US facilitator's manual and scored on a 3-point scale (No/Partially/Yes) and used to assess fidelity. Scoring will range from 1 to 3, with higher scores indicating greater fidelity.

    Time frame: T2 (8 weeks from baseline) for each session (weekly for two months).

  8. EA$E US participant Homework Completion for each session (weekly for two months).

    Homework completion will be documented with a homework completion tracking sheet. Facilitators will verbally ask participants as they check in for each session. Homework attendance will be assess by the proportion of enrolled couples who complete at least 75% of all assigned home practice (6 out of 8).

    Time frame: T2 (8 weeks from baseline) for each session (weekly for two months).

06

Study locations

No study locations are listed for this record.

07

References and documents

Related links

Study documents

  • Protocol and statistical analysis plan · Aug 1, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Due to the sensitive nature of the data being collected, we will share aggregate data, not individual

08

Registry details

Key details

Study ID
NCT07775677
Lead sponsor
George Mason University
Collaborators
National Institute of Mental Health (NIMH), International Rescue Committee, Arizona State University
Responsible party
Sponsor
First posted
Aug 20, 2026
Start date
Nov 2026 (estimated)
Primary completion
May 30, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Aug 20, 2026

Study contacts

Jhumka Gupta, ScD, MPH
Contact
jgupta4@gmu.edu
7039931985
Jhumka Gupta, ScD, MPH
principal investigator · George Mason University College of Public Health
Karin Wachter, PhD
principal investigator · Arizona State University School of Social Work

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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