NCT07775677

Brief 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

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Nov 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 20, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

August 20, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 21, 2026

Last Update Submit

August 18, 2026

Conditions

Keywords

violence preventionimplementation researchmental health

Outcome Measures

Primary Outcomes (8)

  • 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.

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

  • 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

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

  • 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

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

Secondary Outcomes (8)

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

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

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

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

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

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

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

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

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

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

  • +3 more secondary outcomes

Other Outcomes (8)

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

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

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

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

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

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

  • +5 more other outcomes

Study Arms (2)

Standard of care (ongoing economic programming)

OTHER

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

Other: ongoing standard of care

EA$E-US

EXPERIMENTAL

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

EA$E-USBEHAVIORAL

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.

EA$E-US

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

Standard of care (ongoing economic programming)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • couples who are:
  • 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

You may not qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

DepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPersonal Satisfaction

Study Officials

  • Jhumka Gupta, ScD, MPH

    George Mason University College of Public Health

    PRINCIPAL INVESTIGATOR
  • Karin Wachter, PhD

    Arizona State University School of Social Work

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jhumka Gupta, ScD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2026

First Posted

August 20, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

August 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Due to the sensitive nature of the data being collected, we will share aggregate data, not individual