A Phase 2 interventional study of Common Elements Treatment Approach and Enhanced Case Managment in Violence, Parenting and Poverty, sponsored by University of Notre Dame. Recruiting at 1 site in Peru. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by University of Notre Dame · Phase 2, Interventional, and Treatment
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.
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 600 is above the median of 81 across 7,063 interventional studies indexed under Depression.
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Exclusion Criteria:
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
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
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
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.
Depression
Center for Epidemiological Studies Depression Scale: Scores from from 0 to 60, where low scores indicate better outcomes.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12 week post-test, 6-month follow-up, 12-month follow-up
Child Adjustment
Strengths and Difficulties Questionnaire; Total adjustment problems range from 0 to 40, with lower scores indicating lower levels of adjustment problems. Prosocial skills scores range from 0 to 10, with higher scores indicating better prosocial skills.
Time frame: Baseline, 12 week post-test, 6-month follow-up, 12-month follow-up
Emotion regulation & prosocial skills
Social Competence Scale: Emotion regulation scores range from 0 to 24, with higher scores indicating better emotion regulation; prosocial skills range from 0 to 24, with higher scores indicating better prosocial skills.
Time frame: Baseline, 12 week post-test, 6-month follow-up, 12-month follow-up
Days out of work
Days spent out of work in the past month - range of 0 to 30
Time frame: Baseline, 6-month follow-up, 12-month follow-up
Investment in children
Amount of money (in soles) invested in children in the past month. Floor of range is zero; no set ceiling.
Time frame: Baseline, 6-month follow-up, 12-month follow-up
Time investment in children
Amount of time spent doing activities with children: Range from 0 to 6, with higher values indicating more time spent with children.
Time frame: Baseline, 12 week post-test, 6-month follow-up, 12-month follow-up
WHO Disability Index (selected items)
6 items evaluating difficulties with concentration, work and health impacts: Range 0-24 with lower scores indicating better outcomes.
Time frame: Baseline, 6-month follow-up, 12-month follow-up
Decisions in the home
6 items maternal role in decision making on a variety of topics; responses are categorical by decision maker (i.e., you, your partner, you and your partner together, someone else, you with someone else, N/A)
Time frame: Baseline, 6-month follow-up, 12-month follow-up
Plan to share: Yes — De-identified data will be shared at the conclusion of the study.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, 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.
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Apr 2030, 47 months after the start.
Of 143 non-industry phase 2 interventional studies under Depression, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 57. This study's planned 47 months is above that.
Counting every sponsor, half of 196 studies reached it within 31 months; a quarter within 18 and three quarters within 47.
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