Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
608

Summary

Conditions
  • Anxiety
  • Depression
  • Post Traumatic Stress Disorder
  • Substance Abuse
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Adolescents and young adults (AYA) with indicated mental health or behavioral health problems will be randomized to either the in-person CETA (n = 150), T-CETA (n=150), or treatment as usual condition (n = 100), for a total of 400 AYA participants. Each counselor will be trained in both CETA and T-CETA delivery methods.Masking: Single (Outcomes Assessor)Masking Description: Due to the nature of the trainings, masking of AYA participants is not possible. Outcomes assessors who evaluate counselor competency will be masked to the randomization scheme. Data analysts will be masked.Primary Purpose: Treatment

Participation Requirements

Age
Between 15 years and 125 years
Gender
Both males and females

Description

The overall objective of this study is to evaluate implementation and service delivery strategies that can reduce the science-to-practice gap of evidence-based treatments (EBT) for mental health. Although evidence suggests that mental health treatments are acceptable and efficacious in low-and-middl...

The overall objective of this study is to evaluate implementation and service delivery strategies that can reduce the science-to-practice gap of evidence-based treatments (EBT) for mental health. Although evidence suggests that mental health treatments are acceptable and efficacious in low-and-middle income countries (LMIC) for the treatment of common mental disorders, there remains a gap in our understanding of how to bring these interventions to scale. Significant challenges include the high cost of in-person training, sustaining counselors in EBT, and limited client access to effective care. The aim of this study is to test whether delivery of telephone CETA (T-CETA) can produce non-inferior, or similar, results to the standard in-person CETA for reducing mental and behavioral health problems among AYA and whether CETA and T-CETA are superior to treatment as usual (TAU) in reducing these problems. The study design is a randomized, non-inferiority trial. CETA trainers (up to n=6) will be identified from an existing cadre of Zambian trainers-in-training (TTT), who will facilitate technology-delivered trainings for prospective counselors (up to n = 50) from several partner organizations in Zambia. Counselors who participate in the training will be trained in both in-person CETA and T-CETA. Once trained, counselors will provide treatment to AYA clients randomized to the CETA or T-CETA condition. Following completion of the study, TAU control participants will be offered CETA. The transdiagnostic treatment being scaled up, CETA, was effective in several previous randomized clinical trials in LMIC settings with lay providers, including in Zambia. CETA provides the basis for feasible scale-up through the use a single therapy to treat multiple common mental disorders with varying severities, an approach that is more cost-effective than implementing multiple single-disorder focused psychotherapy treatments in LMIC. Primary outcomes will be AYA client mental health and behavioral health outcomes. Secondary outcomes include trainer and counselor CETA competency and knowledge, and qualitative interviews of the acceptability, appropriateness, feasibility, and scale-up potential of technology-based CETA training and treatment delivery. The cost-effectiveness of the technology training strategy and the two treatment delivery methods will also be evaluated. The project will specifically strengthen the capacity of: 1) study staff to conduct mental health clinical science research, 2) counselor and trainers in CETA training, supervision and delivery, and 3) policy and decision makers to interpret and appropriately utilize the scientific evidence to improve mental health policies and programs. This proposal leverages previous studies and strong collaborations in Zambia with the Ministry of Health and numerous local organizations. Results from this trial will produce effectiveness and costing data on treatment delivery strategies that could inform the scale-up potential of diverse EBT in LMIC across and beyond mental health. This research study ultimately addresses both the treatment and implementation gaps in lower-resource settings globally.

Tracking Information

NCT #
NCT03458039
Collaborators
  • Johns Hopkins University
  • University of Alabama at Birmingham
  • Education Development Center, Inc.
  • Columbia University
Investigators
Principal Investigator: Izukanji Sikazwe, MBChB Chief Executive Officer