Evaluating Implementation Strategies to Scale-up Transdiagnostic Evidence-based Mental Health Care in Zambia

NCT03458039 | Completed DMC

• 1 other identifier: R01MH115495
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

Brief Summary

This study utilizes a Hybrid Type 1 multi-arm parallel group randomized control design to compare the effectiveness of an evidence-based treatment (CETA) delivered either in-person or via telephone, compared with a treatment as usual (TAU) control group, on improving adolescent and young adult (AYA) mental and behavioral health outcomes. The study will also gather information on counselor treatment knowledge, fidelity and competency following a technology-delivered training. Lastly, the cost associated with these strategies will be explored to inform future scale-up of training and services. This study will be conducted in Lusaka, Zambia and participants will be enrolled at four different levels: prospective CETA trainers, prospective CETA counselors, AYA clients, and research/organizational staff. AYA clients are the primary participant type.

Conditions

Depression; Post-traumatic Stress Disorder; Anxiety; Substance Abuse

Keywords

mental health capacity building; low and middle-income country; train the trainer strategy; technology-based training; implementation science; adolescents and young adults (AYA)

Outcome Measures

Primary Outcomes (2)

• Change in adolescent and young adult (AYA) internalizing and externalizing symptoms as measured by the Youth Self Report

  Baseline; within one month following CETA treatment (~3-4 months post-baseline for TAU participants); 6-month follow-up after treatment (~9 months post-baseline for TAU).

• Change in adolescent and young adult (AYA) trauma symptoms as measured by the Child PTSD Symptom Scale

  Baseline; within one month following CETA treatment (~3-4 months post-baseline for TAU participants); 6-month follow-up after treatment (~9 months post-baseline for TAU).

Secondary Outcomes (7)

• Change in adolescent and young adult (AYA) substance use as measured by the ASSIST

  Baseline; within one month following CETA treatment (~3-4 months post-baseline for TAU participants); 6-month follow-up after treatment (~9 months post-baseline for TAU).

• Change in adolescent and young adult (AYA) physical health and functioning as measured by the EQ-5D-Y

  Baseline; within one month following CETA treatment (~3-4 months post-baseline for TAU participants); 6-month follow-up after treatment (~9 months post-baseline for TAU).

• Trainer competency & knowledge of Common Elements Treatment Approach (CETA).

  Outcomes at the trainer level will be assessed at three time points: 1) after CETA counselor training (baseline), 2) three months into active cases (3 months post-baseline), and 3) at posttreatment (~9 months post-baseline).

• Counselor competency & knowledge of Common Elements Treatment Approach (CETA).

  Outcomes at the counselor level will be assessed at three time points: 1) after baseline CETA counselor training, 2) three months into active cases (3 months from baseline), and 3) following provision of CETA treatment (~9 months post-baseline).

• Cost effectiveness of adapting training for technology delivery, and in-person and telephone delivery of CETA.

  Costs assessed throughout course of the study up to 48 months.

Study Arms (3)

In-person CETA

EXPERIMENTAL

This is the in-person delivery method of the Common Elements Treatment Approach (CETA).

Behavioral: In-person CETA

Telephone CETA (T-CETA)

EXPERIMENTAL

This is the technology-based delivery method for the Common Elements Treatment Approach (CETA).

Behavioral: Telephone CETA

Treatment As Usual

ACTIVE COMPARATOR

This is the treatment as usual control condition who will engage with their usual care in the community and will receive CETA, if desired, following completion of the study.

Behavioral: Treatment as Usual (TAU)

Interventions

In-person CETA BEHAVIORAL

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.

Also known as: CETA

In-person CETA

Telephone CETA BEHAVIORAL

For adaptation of the CETA manual for telephone delivery, the Applied Mental Health Research (AMHR) Group at Johns Hopkins University (JHU) reviewed evidence-based telehealth strategies and recommendations, telehealth ethical and legal guidelines, and clinical recommendations from telehealth providers. In addition, local TTTs 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.

Also known as: T-CETA

Telephone CETA (T-CETA)

Treatment as Usual (TAU) BEHAVIORAL

The control condition is defined as 'treatment as usual'. In Zambia, there are no formal services or standard of care treatments for mental and behavioral health problems among AYA. There are, however, organizations (such as non-governmental organizations) operating in Lusaka that provide intermittent services for these types of problems. Some AYA receive informal counseling from parish priests or other leaders in their communities. In this study we are therefore defining these types of informal services as 'treatment-as-usual.' We will closely track the type, number, and degree of these kinds of services that all participants receive and access. Following the conclusion of the study, we will offer the CETA intervention to control participants if it has been found to be safe and effective

Also known as: TAU

Treatment As Usual

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Interest in providing CETA
• Time/availability to participate in the study
• Minimal education level is comparable to a high school education
• Ability to speak English fluently and speak at least 1 local language (Nyanja or Bemba)
• Completion of an in-person interview with study team investigators demonstrating strong communication skills
• Planning to stay in study area (Lusaka) to provide treatment to clients

You may not qualify if:

• \. If previously trained in CETA
• CETA Trainers
• All eligibility criteria for CETA counselors
• Interest in teaching CETA
• Completion of the CETA training
• Completion of a minimum of 3 CETA cases under supervision
• Adolescent/Young Adult (AYA) Clients
• years of age
• Attend or be referred to study site
• Live in the area served by a study site (i.e., not staying temporarily)
• Ability to speak one of the study languages (English, Bemba, or Nyanja)
• 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:
• Youth Self Report Internalizing Scale (≥14)
• Youth Self Report Externalizing Scale (≥8)
• Child PTSD Symptom Scale (≥11.5)

Sponsors & Collaborators

• Centre for Infectious Disease Research in Zambia: lead
• Johns Hopkins University: collaborator
• University of Alabama at Birmingham: collaborator
• Education Development Center, Inc.: collaborator
• Columbia University: collaborator

Study Sites (1)

Centre for Infectious Disease Research in Zambia

Lusaka, Zambia

Location

Related Publications (8)

• Kieling C, Baker-Henningham H, Belfer M, Conti G, Ertem I, Omigbodun O, Rohde LA, Srinath S, Ulkuer N, Rahman A. Child and adolescent mental health worldwide: evidence for action. Lancet. 2011 Oct 22;378(9801):1515-25. doi: 10.1016/S0140-6736(11)60827-1. Epub 2011 Oct 16.

  PMID: 22008427 BACKGROUND

• Benjet C. Childhood adversities of populations living in low-income countries: prevalence, characteristics, and mental health consequences. Curr Opin Psychiatry. 2010 Jul;23(4):356-62. doi: 10.1097/YCO.0b013e32833ad79b.

  PMID: 20520546 BACKGROUND

• Saxena S, Thornicroft G, Knapp M, Whiteford H. Resources for mental health: scarcity, inequity, and inefficiency. Lancet. 2007 Sep 8;370(9590):878-89. doi: 10.1016/S0140-6736(07)61239-2.

  PMID: 17804062 BACKGROUND

• Kakuma R, Minas H, van Ginneken N, Dal Poz MR, Desiraju K, Morris JE, Saxena S, Scheffler RM. Human resources for mental health care: current situation and strategies for action. Lancet. 2011 Nov 5;378(9803):1654-63. doi: 10.1016/S0140-6736(11)61093-3. Epub 2011 Oct 16.

  PMID: 22008420 BACKGROUND

• Ray ML, Wilson MM, Wandersman A, Meyers DC, Katz J. Using a training-of-trainers approach and proactive technical assistance to bring evidence based programs to scale: an operationalization of the interactive systems framework's support system. Am J Community Psychol. 2012 Dec;50(3-4):415-27. doi: 10.1007/s10464-012-9526-6.

  PMID: 22711269 BACKGROUND

• Pearce J, Mann MK, Jones C, van Buschbach S, Olff M, Bisson JI. The most effective way of delivering a train-the-trainers program: a systematic review. J Contin Educ Health Prof. 2012 Summer;32(3):215-226. doi: 10.1002/chp.21148.

  PMID: 23173243 BACKGROUND

• Murray LK, Skavenski S, Kane JC, Mayeya J, Dorsey S, Cohen JA, Michalopoulos LT, Imasiku M, Bolton PA. Effectiveness of Trauma-Focused Cognitive Behavioral Therapy Among Trauma-Affected Children in Lusaka, Zambia: A Randomized Clinical Trial. JAMA Pediatr. 2015 Aug;169(8):761-9. doi: 10.1001/jamapediatrics.2015.0580.

  PMID: 26111066 BACKGROUND

• Figge CJ, Kane JC, Skavenski S, Haroz E, Mwenge M, Mulemba S, Aldridge LR, Vinikoor MJ, Sharma A, Inoue S, Paul R, Simenda F, Metz K, Bolton C, Kemp C, Bosomprah S, Sikazwe I, Murray LK. Comparative effectiveness of in-person vs. remote delivery of the Common Elements Treatment Approach for addressing mental and behavioral health problems among adolescents and young adults in Zambia: protocol of a three-arm randomized controlled trial. Trials. 2022 May 19;23(1):417. doi: 10.1186/s13063-022-06319-4.

  PMID: 35590348 DERIVED

MeSH Terms

Conditions

Depression; Stress Disorders, Post-Traumatic; Anxiety Disorders; Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders

Study Officials

• Izukanji Sikazwe, MBChB

  Chief Executive Officer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: March 8, 2018
• Study Start: February 25, 2020
• Primary Completion: October 31, 2023
• Study Completion: February 29, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Pending
• Access Criteria: Pending

Locations

ZA (1)