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

NCT07667738 | Recruiting Phase 2 DMC

• 2 other identifiers: 25-09-9575R01HD116815
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• Depression

  Center for Epidemiological Studies Depression Scale: Scores from from 0 to 60, where low scores indicate better outcomes.

  Baseline, 12-week post-test, 6-month follow-up, 12-month follow-up

• Posttraumatic Stress

  PTSD Checklist for DSM-5: Scores range from 0 to 80, where lower scores indicate better outcomes.

  Baseline, 12-week post-test, 6-month follow-up, 12-month follow-up

• Anxiety

  Generalized Anxiety Disorder - 7: Scores range from 0-21, with lower scores indicating better outcomes.

  Baseline, 12-week post-test, 6-month follow-up, 12-month follow-up

• Wellbeing

  WHO-5 Wellbeing Index: Scores range from 0-25 with higher scores indicating better outcomes.

  Baseline, 12-week post-test, 6-month follow-up, 12-month follow-up

• Intimate Partner Violence

  Escala de Violencia; Scores range from 0-3, with lower scores indicating lower frequency of violence.

  Baseline, 12-week post-test, 6-month follow-up, 12-month follow-up

• Parenting - observed

  Dyadic Parent Child Interaction Coding System: Scoring is a tally based system based on number of specific behaviors present; low scores indicate lower frequency of behavior and higher scores indicate higher frequency of behavior. Range floor is zero, with no set ceiling.

  Baseline, 12-week post-test, 6-month follow-up, 12-month follow-up

• Parenting - Self-reported

  Alabama Parenting Scale - Preschool Version: Positive parenting ranges from 0-48, inconsistent parenting from 0-28 and punitive parenting from 0-20. Higher scores indicate higher frequency of parenting behavior.

  Baseline, 12 week post-test, 6-month follow-up, 12-month follow-up

Secondary Outcomes (7)

• Child Adjustment

  Baseline, 12 week post-test, 6-month follow-up, 12-month follow-up

• Emotion regulation & prosocial skills

  Baseline, 12 week post-test, 6-month follow-up, 12-month follow-up

• Days out of work

  Baseline, 6-month follow-up, 12-month follow-up

• Investment in children

  Baseline, 6-month follow-up, 12-month follow-up

• Time investment in children

  Baseline, 12 week post-test, 6-month follow-up, 12-month follow-up

Study Arms (2)

CETA + Enhanced Case Management

EXPERIMENTAL

Participants receiving CETA will receive a modular CBT 1-on-1 therapeutic program for approximately 12 weeks. They will also receive access to the standard of care provided by the partner agency (enhanced case management).

Behavioral: Common Elements Treatment Approach; Behavioral: Enhanced Case Managment

Enhanced Case Management

ACTIVE COMPARATOR

ECM will include a needs assessment and referral to needed resources, with a follow-up interview after approximately 12 weeks to see which resources were accessed.

Behavioral: Enhanced Case Managment

Interventions

Common Elements Treatment Approach BEHAVIORAL

CETA was designed for implementation with lay paraprofessionals working in LMICs. It has shown evidence of effectiveness in addressing posttraumatic stress, depression, anxiety, IPV, substance use, and suicide/safety issues. CETA employs a precision science approach using a modular framework. That is, all participants receive a common core of elements (i.e., Engagement, Cognitive Coping/Restructuring, \[and for this study\] Caregiver Skills) with additional specific elements guided by individual symptom presentation, thus balancing standardization and personalization. Elements of CETA include: Engagement, Psychoeducation, Anxiety Management Strategies, Behavioral Activation, Cognitive Coping/Restructuring, Imaginal \& Live Gradual Exposure, Suicide/Homicide/Danger Assessment and Planning, and Substance Use CBT/MI for Alcohol and Drug Use. The Caregiver Skills module includes information about effective parenting skills for preschool-aged children such as praise, selective

Also known as: CETA

CETA + Enhanced Case Management

Enhanced Case Managment BEHAVIORAL

Women assigned to both conditions will receive ECM, which is a standardized (already existing) service at INFAM that includes four stages: intake, referral, guided support, and follow-up. At intake, women will participate in a structured interview that includes a brief assessment of multisystem risk and protective factors (i.e., social, economic, daily living, basic needs, and physical and mental health). Depending on assessed needs, women will be referred to relevant services. As needed, the social worker will provide guided support for accessing services (e.g., helping with paperwork for insurance applications). The ECM process is concluded by a follow-up interview to ascertain progress in accessing referrals and documents women's progress toward identified social service referral goals across domains.

CETA + Enhanced Case Management; Enhanced Case Management

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Notre Dame: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Centro Patrizio Peyton

Lima, Peru

RECRUITING

MeSH Terms

Conditions

Depression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Central Study Contacts

Laura Miller-Graff, PhD

CONTACT

574-631-3245; lmiller8@nd.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 25, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Code an analytic plan will be made available as a part of publications; study protocol will be published open access during the study
• Access Criteria: All study data will be open access with the exception of raw data, which is available by reasonable request.

Locations

PE (1)