Evaluating the Effectiveness of the Common Elements Treatment Approach (CETA) in Peru: Mechanisms of Individual and Intergenerational Change
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
研究概览
简要总结
Recent advances in intervention research have revealed the promise of transdiagnostic, modular approaches implemented by lay paraprofessionals for the treatment of the most prevalent mental health concerns in settings affected by adversity (e.g., anxiety, depression, posttraumatic stress), but to date, few effectiveness trials have examined the indirect effects of treatment on intergenerational and economic outcomes or moderators of treatment effectiveness. There is thus a critical need not only for the continued expansion of the evidence-basis for care in low-resource settings, but also for the evaluation of factors contributing to effectiveness across multiple dimensions to gain a better understanding of the sustainability, long-term benefits, and cost-effectiveness of these approaches. The current study will conduct a rigorous evaluation of an existing program, the Common Elements Treatment Approach (CETA) with women (N=300) who are mothers of young children (ages 4-6). The trial will take place in the context of an integrated community care setting in Lima, Peru's most populous and impoverished district, San Juan de Lurigancho. The primary aims are to (1) evaluate the primary and indirect effects of CETA (2) examine moderators of treatment effectiveness, including implementation quality and neighborhood factors and (3) examine CETA's cost effectiveness. The central hypotheses are that (H1a) CETA will improve women's mental health, intimate partner violence, and parenting and that (H1b) CETA will have indirect benefits for women's economic outcomes and for their children's adjustment. It is also hypothesized (H2) that effectiveness will be enhanced by strong implementation quality and the presence of neighborhood promotive factors, and weakened by neighborhood disadvantage. Hypotheses will be evaluated using an RCT employing a longitudinal design with assessments at baseline (T1), post-test (T2), 6-month follow-up (T3) and 12-month follow-up (T4). Women will be randomized into the intervention condition (CETA + Enhanced Case Management [ECM]) or the comparison condition (ECM). Robust, multi-source (i.e., participant, therapist, supervisor, census data) and multi-method data (i.e., interview, observational assessment, google street view coding) will be gathered. The contribution will be significant by advancing research on both direct and long-term benefits of maternal mental health care for family systems, and is likely to provide important insights into the sustainability and cost effectiveness of these approaches. The expected outcome is an evidence-based, cost-effective, integrated approach to maternal mental health care that can be readily implemented by local organizations. Further, it is anticipated that learnings from this project will respond to broader global public health concerns and provide opportunity for cross-context reciprocal innovation. Expanding the evaluation of CETA delivered in Spanish not only has advantages for the specific context under study, but provides an important foundation for addressing health disparities in Spanish-language mental health services in the US as well.
详细描述
The study will occur in the San Juan de Lurigancho district of Lima, Peru. Women who are mothers of children between the ages of 4 and 6 (N=300) will be recruited. Every effort will be made to recruit a diverse sample that reflects the demographics of the local community. Implementation of the project will be done through the Instituto de Pastoral de La Familia (INFAM), a community care organization offering a range of social services to families living in San Juan de Lurigancho district. Participants will be recruited from the community using direct referrals, self-referrals, and via informational flyers at local organizations.
Interested and potentially eligible women will contact the project coordinator, who will conduct an eligibility screen. In order to participate, women must: (1) live in San Juan de Lurigancho, Lima, Peru, (2) be at least 18 years of age, (3) have a child between the ages of 4 and 6, and (4) have the ability to travel to INFAM for study assessments and treatment sessions. Exclusion criteria include: (1) living outside of San Juan de Lurigancho, (2) those who are unable or unwilling to attend in-person sessions, or (3) the presence of severe intellectual disabilities or mental illness (these individuals will be referred to other local services). After confirming eligibility and interest, the most effective means of contacting the participant will also be established, including days and times in which calls can be accepted. Interested women will then be scheduled for a baseline interview, which will be conducted by trained research staff.
Enrollment will continue for approximately 1.75 years. The expected duration of the study for each participant will be approximately 14.5 months.
The primary aims of the of the proposed project are to: (1) evaluate the primary and indirect effects of CETA, (2) examine moderators of treatment effectiveness, including implementation quality and neighborhood factors, and (3) examine cost-effectiveness.
This objective will be evaluated in a randomized clinical trial with women (N=300) assigned to one of two conditions: Common Elements Treatment Approach + Enhanced Case Management (CETA + ECM) or ECM alone. Enhanced case management is considered the standard of care in this context. Women will be individually randomized at a 1:1 ratio across conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •live in San Juan de Lurigancho, Lima, Peru,
- •be at least 18 years of age,
- •have a child between the ages of 4 and 6, and
- •have the ability to travel to INFAM for study assessments and treatment sessions
排除标准
- •living outside of San Juan de Lurigancho,
- •those who are unable or unwilling to attend in-person sessions, or
- •the presence of severe intellectual disabilities or mental illness (these individuals will be referred to other local services)
