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Evaluating the Effectiveness of the Common Elements Treatment Approach (CETA) in Peru: Mechanisms of Individual and Intergenerational Change

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…

ClinicalTrials.gov IDNCT07667738
PhasePHASE2
Enrollment600
SponsorUniversity of Notre Dame
Age18 Years
SexFEMALE
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Conditions studied

Violence, Parenting, Poverty, Depression, Mental Health, Posttraumatic Stress, Economic Factors, Child Psychology

About this study

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…

Interventions

Primary outcomes

Eligibility information

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.