IPV Prevention Among FDP

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeorge Mason University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • EA$E-US

    Behavioral

    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 care

    Other intervention

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

Treatment groups

107 Participants
are divided into 2 treatment groups
Group A: Standard of care (ongoing economic programming)Other 1 intervention
Group B: EA$E-USExperimental treatment 1 intervention

Trial outcomes

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)

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)

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).

Locations

This trial has no locations.

Sponsors and contacts

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George Mason University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

International Rescue Committee

Collaborator

Arizona State University

Collaborator

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