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

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.

CETA was specifically designed for implementation with lay paraprofessionals working in LMICs. It focuses on transdiagnostic approaches to addressing anxiety, posttraumatic stress, and depression. It also includes intervention elements related to IPV and caregiving CETA employs a flexible approach that is guided by the specific symptom presentation of the individual, thus balancing standardization and personalization - a key priority in global mental health. Components of CETA include the following modules: Engagement, Psychoeducation, Anxiety Management Strategies, Behavioral Activation, Cognitive Coping/Restructuring, Imaginal Gradual Exposure, In Vivo Exposure, Suicide/Homicide/Danger Assessment and Planning, and Screening/Brief Intervention for Alcohol. Recent work on CETA has also included a Caregiver Skills component, which aims to teach caregivers effective parenting skills, such as praise, selective attention, special time/positive attention, and behavior management. Depending upon client presentation, as informed by both baseline assessments and clinical presentation, CETA may range in length from 8-12, 1.5 hour sessions.

ECM will be provided to women in both conditions. ECM will include four stages: intake, referral, guided support, and follow-up. At intake, women will participate in a structured interview that includes a brief assessment of risk and protective factors in the following domains: social, economic, daily living, basic needs, and physical and mental health. Depending on assessed needs, women will be referred for relevant services either at INFAM or in the local community. As needed, the social worker will provide guided support for accessing services (e.g., coordinating with local clinics, helping with paperwork for insurance applications). Following this referral and support process, the social worker completes the social services support by conducting a follow-up interview to ascertain progress in accessing referrals and documents women's progress toward identified social service referral goals.

Baseline and post-test/follow-up questionnaires will each take approximately 2-2.5 hours, and will be administered at INFAM. Prior to beginning the baseline interviews, informed consent will be obtained in accord with current regulations enforced by local law and the institutional review board. During the informed consent process, participants will be informed of the purpose and general content of the program, and confidentiality guidelines and procedures will be reviewed. Interviewers will be trained employees of INFAM, all of whom will receive extensive training on clinical interview methods. They will be supervised by the project coordinator and by a local psychologist. Interviewers will complete a training co-designed by the PI, Co-Is and Consultants; standards of (1) the Notre Dame IRB, (2) standards for scientifically survey evaluation research, and (3) standards for clinical care at in the context of work with high-risk populations to gather sensitive information.

Primary outcome measures for the effectiveness evaluation will be Maternal Mental Health (Anxiety, Depression Posttraumatic Stress), IPV, and Parenting.

• Child Adjustment [Time frame: Baseline, 12 week post-test, 6-month follow-up, 12-month follow-up]
• Emotion regulation & prosocial skills [Time frame: Baseline, 12 week post-test, 6-month follow-up, 12-month follow-up]
• Days out of work [Time frame: Baseline, 6-month follow-up, 12-month follow-up]
• Investment in children [Time frame: Baseline, 6-month follow-up, 12-month follow-up]
• Time investment in children [Time frame: Baseline, 12 week post-test, 6-month follow-up, 12-month follow-up]
• WHO Disability Index (selected items) [Time frame: Baseline, 6-month follow-up, 12-month follow-up]
• Decisions in the home [Time frame: Baseline, 6-month follow-up, 12-month follow-up]