AzTrials
AzTrials

PTSD SymptomsNCT07775677

IPV Prevention Among FDP

A study testing EA$E-US in people with PTSD Symptoms and Violence Prevention, run by George Mason University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
EA$E-US
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
No sites listed yet
Study dates
Nov 2026to 30 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jhumka Gupta, ScD, MPH contact

7039931985

jgupta4@gmu.edu

About this study

Official title: Adaptation and Pilot Trial of an Intervention to Reduce Intimate Partner Violence and Mental Health Symptoms Among Forcibly Displaced Resettled Congolese Populations in the United States

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.

Being tested
EA$E-US, ongoing standard of care
Keywords
violence prevention, implementation research, mental health
Medical subject headings
Depression, Anxiety Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EA$E-USBehavioural

    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.

  • ongoing standard of careOther

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

Study groups in NCT07775677
Study groupRoleWhat they receive
Standard of care (ongoing economic programming)OtherStandard of care, receive ongoing IRC provided services, including economic empowerment services (job training, financial coaching, etc).
Receives: Other: ongoing standard of care
EA$E-USExperimentalCouples randomized to this arm will receive the EA$E-US intervention. This is an 8-session curriculum focusing on communication, healthy communication, conflict resolution, joint decision-making, and coping.
Receives: Behavioral: EA$E-US

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Secondary outcomes (8)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: (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.

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2026
  2. Study startNov 2026 (estimated)
  3. Primary completion30 May 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07775677
Sponsor's protocol ID
AWD00001811
Other IDs
1R34MH139762-01
Status last verified
Jul 2026
First submitted
21 Jul 2026
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Due to the sensitive nature of the data being collected, we will share aggregate data, not individual

Questions about this trial

What is this clinical trial studying?

A study testing EA$E-US in people with PTSD Symptoms and Violence Prevention, run by George Mason University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jhumka Gupta, ScD, MPH (7039931985, jgupta4@gmu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in past month anxiety symptoms assessed by GAD-7 at 5 months (time frame: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in