All study procedures will take place in Lusaka, Zambia. Participants will be recruited from community-based organizations that provide health, education, and social services to AYA in Lusaka. Organizations with access to AYA populations and with existing counseling/mental health services were selected, as they will serve as prime CETA and T-CETA service delivery points, should the study demonstrate feasibility and effectiveness in this population. Selected organizations include a combination of local and international non-governmental organizations (NGOs) and government health clinics. Heterogeneity in implementing sites is desirable to generate robust clinical and implementation evidence.
Overview of Study Design
This study will use a Hybrid Type 1 three-arm parallel group randomized controlled design  to compare the effectiveness of CETA delivered either in-person or via telephone (T-CETA), compared with a treatment as usual (TAU) control group. CETA trainers (up to N = 6) will be identified from an existing cadre of Zambian counselors and will be trained to be CETA trainers via a technology platform. They will be trained to facilitate technology-delivered CETA trainings to new prospective counselors (up to N = 50) recruited from our partnering organizations, who will be trained to deliver both in-person CETA and T-CETA. We will recruit and randomize AYA clients (N = 400) with mental and behavioral health problems from our partnering organizations to one of three conditions: a) CETA, b) T-CETA, or c) TAU. We will evaluate mental and behavioral health outcomes among AYA at baseline, post-treatment (approximately 3–4 months post-baseline), and 6 months post-treatment (approximately 9 months post-baseline) (Fig. 1). Data will also be collected on CETA trainer and counselor competency, fidelity, and knowledge, and implementation constructs (e.g., acceptability, feasibility, cost) associated with training and intervention delivery.
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AYA participants will be between the ages of 15–29 with mental and behavioral health problems as measured by validated screening tools (see Screening). Trainer and counselor participants will be lay providers interested in mental health training. Full eligibility criteria are summarized in Table 1.
Participant Eligibility and Screening
1. 15–29 years of age
2. Attend or be referred to study site
3. Live in the area served by a study site (i.e., not staying temporarily)
4. Ability to speak one of the study languages (English, Bemba, or Nyanja)
5. Screening: Present with one or more common mental/behavioral health problems based on validated screening tools included in the audio computer assisted self-interviewing (ACASI) system. Specifically, the following screening tools and cut-off values:
a. Youth Self Report Internalizing Scale (≥ 14)
b. Youth Self Report Externalizing Scale (≥ 8)
c. Child PTSD Symptom Scale (≥ 12)
a. Currently on unstable psychiatric drug regimen (e.g., altered in past two months)
b. Suicide attempt or active and severe self-harm in past month
c. Psychotic disorder or severe mental illness
Trainers and Counselors
1. 18 years of age or older
2. Interest in providing CETA
3. Time/availability to participate in the study
4. Minimal education level is comparable to a high school education
5. Ability to speak English fluently and speak at least 1 local language (Nyanja or Bemba)
6. Completion of an in-person interview with study team investigators demonstrating strong communication skills
7. Planning to stay in study area (Lusaka) to provide treatment to clients and/or training to new counselors
Trainers: in addition to all of the above:
8. Interest in teaching CETA
9. Completion of the CETA training
10. Completion of a minimum of 3 CETA cases under supervision
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For the recruitment of AYA clients, the research team will conduct half-day training sessions explaining CETA, and for whom and what problems it is appropriate, to all staff at collaborating partner organizations. In addition, a separate 2-hour CETA information meeting will be conducted for home-based care workers that help link individuals to services. Recruitment by home-based care workers connected to partner sites is a process used previously by the research group to help identify, connect, and assure that those in need get services, and mirrors how the program could recruit clients in a real-world setting [72, 73]. Initial contact will be made by partner organization staff or home-based care workers who will explain the study with a recruitment script to AYA, and their primary caregiver for those under age 18, with whom they have previously or currently work. Snowball recruitment methods may also be used to identify additional AYA participants. Recruitment will be conducted in private locations such as a private room in a community location (e.g., church, school) or a private room within the partner organization facilities. AYA that express interest in receiving more information on the study will be connected to the research team.
Trainer and counselor-level participants will be recruited from our collaborating partners and through contacts of local stakeholders like the Ministry of Health to increase the likelihood that provision of CETA continues after the end of the study period. Our collaborating partners and contacts will recommend current staff who they think would be appropriate CETA counselors and have time to provide this service. Potential counselors will also need to submit a resume to the study team, a letter expressing their motivation to be a counselor, and letter of support from their organization. Study staff will interview applicants, and ensure they meet inclusion criteria. Final agreement will be by consensus of study team and collaborating partners.
Consent activities with all participants involves discussing relevant study details including the purpose, treatment details, privacy, and risks and benefits. Informed consent will be obtained from AYA clients (and caregivers, if applicable) in English, Bemba, or Nyanja by trained research assistants. Consent is obtained for participation in all study activities at the screening phase. AYA will be informed that study participation is voluntary and will not impact any ongoing or future services they may receive. Research assistants will be trained in human subjects and responsible conduct of research and receive appropriate certification. For clients under age 18, research assistants will also obtain informed consent and permission from the AYA’s primary caregiver to obtain assent from the AYA participant.
Screening and Baseline Assessment
The screening portion of the baseline assessment consists of demographic information, internalizing and externalizing symptoms, and posttraumatic stress. Screening instruments will be administered using the audio computer assisted self-interviewing (ACASI) system. Participants can navigate through the questionnaires themselves using a laptop computer while listening to the questions through headphones and seeing the question and response options on the screen. A research assistant will be positioned nearby in case the participant has any difficulty. We have used ACASI extensively with AYA populations in Zambia and found it to be an acceptable and feasible approach for measuring mental and behavioral health outcomes. All measures included in the ACASI have previously been used by our team with similar study populations and are available in English, Bemba, and Nyanja [35, 68, 70–72].
Broadband Mental Health Functioning (Youth Self Report (YSR); ). The YSR is a 112-item measure of broadband mental health symptoms on a 3-point Likert scale (0 = Not True, 1 = Somewhat True, 2 = Very True or Often True). The measure produces 8 subscales and two broad internalizing and externalizing symptom scores. Eligibility cutoffs of ≥14 and ≥8 will be used for the internalizing and externalizing subscale scores, respectively, based on our previous validity study .
Posttraumatic Stress Symptoms (Child PTSD Symptom Scale (CPSS); ). The CPSS is a 17-item scale that corresponds to DSM-5 criteria for PTSD on a 4-point Likert scale (0 = Not at all or only one time, 1 = Once a week or less/once in a while, 2 = 2 to 4 times a week/half the time, 3 = 5 or more times a week/almost always). Items produce a total Symptom Severity scale. Based on our previous validity study in Zambia, an eligibility cutoff of ≥12 will be used .
Participants who do not meet eligibility cutoffs on screening measures will exit the study and be provided resources for mental health and other social services in their area. Eligible AYA participants will continue to complete the second portion of the baseline assessment via the ACASI system, which includes measures of substance use, aggression/violence, functioning, and COVID-19 vaccine hesitancy (see Outcomes).
Randomization and blinding
Each participant will be assigned a unique ID number by the research assistant during the screening/baseline assessment. Randomization will occur at the individual AYA level and be stratified by site. Following determination of eligibility and completion of the baseline assessment, the research assistant will communicate the ID number to a study staff based at research headquarters who will not interact with study participants. This study staff will maintain a randomization sequence that will be developed a priori by a U.S.-based research staff. This list will not be available or viewable to data collectors in Zambia. The list will have a sequence of treatment assignments (CETA or T-CETA or TAU) in random order, stratified by site, produced via a random number generator in Microsoft Excel. Randomization will be imbalanced (1.5 CETA: 1.5 T-CETA: 1 TAU) due to different sample size requirements in the TAU control arm (see Data Analysis). Eligible AYA participants will be assigned a condition based on the next available slot on the randomization list and inform field staff of the assignment. At this point, field staff will not be blinded to condition assignment for participants they assess. Eligible AYA clients will be informed immediately of the result of the randomization and appropriate next steps: CETA and T-CETA participants will be told that a counselor will be contacting them within 48 hours to setup the first session; TAU participants will be told that the study team will contact them in approximately 3 months to schedule their first post-assessment. The use of ACASI will result in the outcomes assessments being blinded; data analysts will also be blind to intervention status when conducting analyses. Due to the nature of the intervention, neither counselors nor AYA clients will be blinded.
The Common Elements Treatment Approach (CETA) is a transdiagnostic, multi-problem intervention designed to address adult and youth trauma, depression, anxiety, safety, and substance use . It is comprised of a small set of common elements found to be efficacious and prevalent across a range of EBTs to treat common mental health problems. CETA was designed to be flexible in the elements utilized, their order, and their dose (number of sessions) to allow counselors to address heterogeneity, comorbidity, and symptom fluctuations in and across clients. Treatment typically consists of 6 to 12 weekly, approximately 60-minute sessions delivered by lay workers.
For adaptation of the CETA manual for telephone delivery, we reviewed evidence-based telehealth strategies and recommendations, telehealth ethical and legal guidelines, and clinical recommendations from telehealth providers. In addition, local trainers-in-training in multiple contexts reviewed telehealth modifications and provided input that was incorporated into the final T-CETA manual used in this study. No changes were made to the structure, duration, and dose of CETA sessions, treatment components, or measurement-based clinical decision-making processes. Telehealth modifications, additions, and strategies were incorporated throughout the manual in delineated “telehealth boxes.” This way, the original manual was maintained outside of the telehealth boxes, allowing for clear identification and training of telehealth modifications for both new and existing CETA counselors. A pilot phase was conducted in Zambia to explore the feasibility and acceptability of T-CETA and to obtain feedback for modifying the telehealth additions or implementation strategies. Qualitative results highlighted barriers to T-CETA treatment (i.e., poor connection; client phones off or not having phones; lack of private spaces) and solutions to these barriers (i.e., using community staff’s phone for sessions; obtaining multiple contacts for participants; home visits). For those with access to a telephone, T-CETA was deemed by participants as acceptable and effective.
Treatment as usual control
Participants randomized to the TAU condition will be encouraged to continue engaging with support services normally offered in their community, such as those provided by the partnering organization, and the types and utilization of these services will be tracked. Counselors will check-in with TAU participants monthly to assess safety; any participant with a safety risk will be contacted by a counselor to complete a safety plan and be monitored. All TAU participants will receive a full course of CETA, if desired, after completion of the active study aims.
CETA training and supervision activities in this study build on the existing apprenticeship model for lay providers to become mental health counselors . In this model, the trainer initially assumes responsibility for teaching core skills and guiding the prospective counselor. After the initial training, supervisors, who may be identified beforehand or from the cohort of new counselors, are responsible for acting as the link between counselors and trainers. Before counselors begin delivering the intervention to clients, supervisors run practice groups with prospective counselors, which are then followed by supervision groups. Practice groups involve role-plays of a particular intervention component or skill, while supervision groups involve each prospective counselor going through one or two pilot cases with a supervisor who has previously piloted the case themselves with a trainer. When supervisors are providing guidance during practice and supervision groups to counselors, supervisors also engage in weekly calls with a trainer to receive consultation and support. At every level, each individual grows in their role over time and develops the necessary skills so that those who deliver coaching and support eventually provide minimal guidance. For this study, trainers-in-training (N= up to 6) will learn how to train new counselors and supervisors via the technology platform.
The technology-based TTT developed for this study consists of 10 days of trainers-in-training reviewing CETA components on the tech platform, expert CETA trainers modeling training components live via video chat, and live and pre-recorded video observation of trainers-in-training role-plays by expert CETA trainers. Role-plays by trainers-in-training will be rated using a structured rating system, with feedback provided during live video sessions.
Following the TTT, groups of CETA trainers-in-training (pairs, or triplet groups) will each facilitate separate technology-delivered CETA training to the new prospective CETA counselors from our partnering organizations. Trainers-in-training will facilitate technology-delivered trainings to prospective counselors, which include training on standard CETA and T-CETA delivery. Each training will be conducted with approximately 25 counselors (N = up to 50).
The primary outcomes in the trial will be AYA trauma symptoms (as measured by the CPSS), internalizing symptoms, and externalizing behaviors (both measured by the YSR) administered via ACASI as described in the Screening section. Secondary outcomes among AYA, also administered via ACASI, include substance use, which will be measured with the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) [72, 81] and aggression/violence as measured by the Youth Victimization Scale . Outcomes are assessed at baseline, post-treatment completion (approximately 3-4 months post-baseline for TAU participants), and 6 months post-treatment completion (approximately 9 months post-baseline for TAU participants). The primary timepoint is post-treatment.
In addition to AYA outcomes, we will collect preliminary data on counselor and trainer competency, fidelity, and knowledge. This will be collected at various points throughout the study through standardized role plays and CETA knowledge tests. Mixed methods interviews will be conducted among clients, counselors, and trainers to explore acceptability and feasibility of CETA training and delivery. We will also collect data on health utility among AYA using the EuroQol 5-Dimensions for Youth (EQ-5D-Y) [83, 84] to inform the cost-effectiveness analyses. In all, AYA participants will be engaged in the study for approximately 9-12 months.
All data collected on paper forms will include only the participant’s ID number. Paper forms will be transferred securely in study vehicles to the storage site where they will be kept in locked filing cabinets within locked offices. Electronic data capture using the ACASI program will also only include participant ID numbers and be stored on encrypted drives.
Analysis will be done using an intent-to-treat approach. Mixed effects regression models will be estimated for each mental/behavioral health outcome. Models will include fixed effects of treatment group, time, and a group X time interaction term. Random effects will include client ID and counselor ID. There will be two sets of analyses. First, we will conduct a superiority analysis, in which each of the CETA arms (CETA and T-CETA) is separately compared to TAU. Second, we will conduct a non-inferiority analysis in which we will compare outcomes between the CETA and T-CETA groups.
The total number of AYA participants will be N=400. We conducted power calculations for each of the three primary outcomes for which AYA will be enrolled into the study (trauma symptoms, internalizing symptoms, externalizing behaviors). All three required similar sample sizes; trauma symptoms required the largest sample size and is presented here. Based on a previous study with AYA using the same trauma symptom scale as this study (CPSS) , we hypothesize a baseline mean value of approximately 19.0 and standard deviation of 13. For the superiority analyses, in which we will separately compare each CETA condition (in-person CETA and T-CETA) to the TAU control, we will assume an alpha=0.025 to account for two comparisons. Further assuming power=.80 and an expected minimum effect size of each CETA condition compared to TAU of 0.5, we would require 78 persons per arm. For the non-inferiority analysis, in which we will compare the two CETA conditions to each other, we assume an alpha=0.05, power=80%, and a non-inferiority margin of 4.7, which is equivalent to one-third of the anticipated standard deviation. Previous studies have indicated that differences in outcomes that are less than one third of the standard deviation are considered not practically meaningful. Based on these assumptions we would require 114 in each CETA arm for the non-inferiority comparison. Using the more conservative estimate for the CETA conditions (N=114 each) and the estimate for the TAU (N=78) yields a total sample size of N=306. Assuming 20-25% attrition based on previous studies, we have inflated the final sample size to N=400 (N=100 TAU, N=150 CETA, N=150 T-CETA).
Incremental cost-effectiveness analysis will compare the cost-effectiveness of CETA and T-CETA relative to TAU. We will first derive quality adjusted life years (QALYs) from health utility reported at each follow up time point by AYA, and then estimate differences in mean QALYs gained per treatment condition over study follow up using the mixed effects models detailed above. We will then divide incremental QALYs gained under CETA and T-CETA by the incremental cost of each relative to TAU from the economic perspective of the healthcare provider (i.e., payer’s perspective) to estimate the primary cost-effectiveness outcome: incremental cost per QALY gained. Sensitivity analyses will be undertaken to examine uncertainty around the cost-effectiveness estimates, and further interpreted using cost-effectiveness acceptability curves that reveal to decision-makers the probability of the intervention being cost-effective compared to the alternative, given different (implicit monetary) values placed on incremental improvements in the outcome measurement and QALYs. cost-effectiveness acceptability curves will be based on bootstrapped regressions (to account for non-normally distributed data) of study group upon net benefits, controlling for clusters.
Data and safety monitoring
In addition to ethical review boards, there will be a data and safety monitoring board (DSMB) with researchers from both Zambia and the United States in relevant areas of expertise. Before study initiation, the DSMB will review and approve all study protocols detailing formal procedures for reporting and tracking all adverse reactions, following study progress, and identifying any need for premature termination of the protocol. No interim analyses will be conducted by the DSMB since the intervention is not considered harmful and to avoid erroneous conclusions by running multiple analyses during the study. All major study protocol changes will undergo ethical review and will be updated in the clinical trials registry.