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.
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
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)
Parallel
Common Elements Treatment Approach
BehavioralCETA 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
Enhanced Case Managment
BehavioralWomen 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.
Posttraumatic Stress
PTSD Checklist for DSM-5: Scores range from 0 to 80, where lower scores indicate better outcomes.
Anxiety
Generalized Anxiety Disorder - 7: Scores range from 0-21, with lower scores indicating better outcomes.
Wellbeing
WHO-5 Wellbeing Index: Scores range from 0-25 with higher scores indicating better outcomes.
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.
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.
Days out of work
Days spent out of work in the past month - range of 0 to 30
Investment in children
Amount of money (in soles) invested in children in the past month. Floor of range is zero; no set ceiling.
Click on the lead sponsor to view all of their trials.
University of Notre Dame
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
