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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 107
- 主要终点
- Change in past month anxiety symptoms assessed by GAD-7 at 5 months
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Standard of care (ongoing economic programming)
Standard of care, receive ongoing IRC provided services, including economic empowerment services (job training, financial coaching, etc).
干预措施: ongoing standard of care (Other)
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.
干预措施: EA$E-US (Behavioral)
结局指标
主要结局
Change in past month anxiety symptoms assessed by GAD-7 at 5 months
时间窗: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)
Generalized Anxiety Disorder 7; 7 items. Scores range from 0 to 21, with higher values indicating greater symptom severity.
Change in depressive symptoms assessed by PHQ-9 at 5 months
时间窗: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)
Patient health questionnaire-9; 9 items; values range from 0 to 27 with higher values indicating greater depressive symptom severity
Change in past month PTSD Symptoms assessed by PTSD checklist at 5 months
时间窗: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)
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
Change in Past month experiences of physical intimate partner violence assessed by WHO Physical violence subscale at 5 months.
时间窗: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)
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.
Change in past month experiences of emotional intimate partner violence assessed by WHO's emotional violence subscale at 5 months.
时间窗: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)
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.
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.
时间窗: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)
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.
Change in past month economic coercion assessed by ECS-20 at 5 months.
时间窗: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)
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.
Change in past month experiences of controlling behaviors assessed by DHS controlling behaviors subscale in 5 months.
时间窗: Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline)
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.
次要结局
- 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))
- Change in Household Decision Making involvement assessed by DHS women's autonomy in household decision making scale at 5 months.(Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline))
- Change in Family Functioning assessed by the feminist grounded family functioning scale at 5 months.(Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline))
- Change in Spousal relationship communication assessed by CFAT communication subscale at 5 months.(Baseline (T1), T2 (immediately after intervention: 8 weeks from baseline), and T3 (5 months after baseline))