Advancing successful implementation of task-shifted mental health care in low-resource settings (BASIC): protocol for a stepped wedge cluster randomized trial

Shannon Dorsey, Christine L Gray, Augustine I Wasonga, Cyrilla Amanya, Bryan J Weiner, C Micha Belden, Prerna Martin, Rosemary D Meza, Andrew K Weinhold, Caroline Soi, Laura K Murray, Leah Lucid, Elizabeth L Turner, Robyn Mildon, Kathryn Whetten, Shannon Dorsey, Christine L Gray, Augustine I Wasonga, Cyrilla Amanya, Bryan J Weiner, C Micha Belden, Prerna Martin, Rosemary D Meza, Andrew K Weinhold, Caroline Soi, Laura K Murray, Leah Lucid, Elizabeth L Turner, Robyn Mildon, Kathryn Whetten

Abstract

Background: The mental health treatment gap-the difference between those with mental health need and those who receive treatment-is high in low- and middle-income countries. Task-shifting has been used to address the shortage of mental health professionals, with a growing body of research demonstrating the effectiveness of mental health interventions delivered through task-shifting. However, very little research has focused on how to embed, support, and sustain task-shifting in government-funded systems with potential for scale up. The goal of the Building and Sustaining Interventions for Children (BASIC) study is to examine implementation policies and practices that predict adoption, fidelity, and sustainment of a mental health intervention in the education sector via teacher delivery and the health sector via community health volunteer delivery.

Methods: BASIC is a Hybrid Type II Implementation-Effectiveness trial. The study design is a stepped wedge, cluster randomized trial involving 7 sequences of 40 schools and 40 communities surrounding the schools. Enrollment consists of 120 teachers, 120 community health volunteers, up to 80 site leaders, and up to 1280 youth and one of their primary guardians. The evidence-based mental health intervention is a locally adapted version of Trauma-focused Cognitive Behavioral Therapy, called Pamoja Tunaweza. Lay counselors are trained and supervised in Pamoja Tunaweza by local trainers who are experienced in delivering the intervention and who participated in a Train-the-Trainer model of skills transfer. After the first sequence completes implementation, in-depth interviews are conducted with initial implementing sites' counselors and leaders. Findings are used to inform delivery of implementation facilitation for subsequent sequences' sites. We use a mixed methods approach including qualitative comparative analysis to identify necessary and sufficient implementation policies and practices that predict 3 implementation outcomes of interest: adoption, fidelity, and sustainment. We also examine child mental health outcomes and cost of the intervention in both the education and health sectors.

Discussion: The BASIC study will provide knowledge about how implementation of task-shifted mental health care can be supported in government systems that already serve children and adolescents. Knowledge about implementation policies and practices from BASIC can advance the science of implementation in low-resource contexts.

Trial registration: Trial Registration: ClinicalTrials.gov Identifier: NCT03243396. Registered 9th August 2017, https://ichgcp.net/clinical-trials-registry/NCT03243396.

Keywords: Adolescents; Children; Evidence-based treatment; Global mental health; Implementation climate; Implementation science; Organizational theory; School-based mental health care; Task-sharing; Task-shifting.

Conflict of interest statement

Dorsey and Murray have received honoraria for providing TF-CBT training and have received grant funding to test TF-CBT. Whetten also has received grant funding to test TF-CBT. Other authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Determinants of Implementation Effectiveness* Legend: *Adapted from Weiner et al., 2009
Fig. 2
Fig. 2
BASIC Stepped Wedge Design and Timeline Legend: Figure 2 depicts the overall study design of the incomplete stepped wedge cluster-randomized trial, including measurement time points for each sequence. A sequence is a group of clusters that initiate the intervention in the same time period. A step is the specific time point that participants receive the intervention and cross over from being treatment-naïve to having received treatment
Fig. 3
Fig. 3
Bungoma South Sub-County Legend: Figure created using material from two sources: Boundaries: Updated November 2017 by Field Information and Coordination Support Section (FICSS), Division of Programme Support and Management (DPSM), UNHCR. https://data.humdata.org/dataset/ken-administrative-boundaries Water bodies: Added December 2007 by World Resources Institute (WRI), Nature’s Benefits in Kenya. https://www.wri.org/resources/data-sets/kenya-gis-data

References

    1. Vigo D, Thornicroft G, Atun R. Estimating the true global burden of mental illness. Lancet Psychiatry. 2019;3(2):171–178. doi: 10.1016/S2215-0366(15)00505-2.
    1. Thornicroft G, Alem A, Dos Santos RA, et al. WPA guidance on steps, obstacles and mistakes to avoid in the implementation of community mental health care. World Psychiatry. 2010;9(2):67–77. doi: 10.1002/j.2051-5545.2010.tb00276.x.
    1. Eaton J, McCay L, Semrau M, et al. Scale up of services for mental health in low-income and middle-income countries. Lancet (London, England) 2011;378(9802):1592–1603. doi: 10.1016/S0140-6736(11)60891-X.
    1. Betancourt TS, Chambers DA. Optimizing an era of global mental health implementation science. JAMA Psychiatry. 2016;73(2):99–100. doi: 10.1001/jamapsychiatry.2015.2705.
    1. Patel V, Araya R, Chatterjee S, et al. Treatment and prevention of mental disorders in low-income and middle-income countries. Lancet (London, England) 2007;370(9591):991–1005. doi: 10.1016/S0140-6736(07)61240-9.
    1. Patel V. The future of psychiatry in low and middle income countries. Psychol Med. 2009;39(11):1759–1762. doi: 10.1017/S0033291709005224.
    1. Van Ginneken N, Tharyan P, Lewin S, et al. Non-specialist health worker interventions for the care of mental, neurological and substance-abuse disorders in low- and middle-income countries. Cochrane Database Syst Rev. 2013;11:CD009149. doi: 10.1002/14651858.CD009149.pub2.
    1. Murray Laura K., Skavenski Stephanie, Kane Jeremy C., Mayeya John, Dorsey Shannon, Cohen Judy A., Michalopoulos Lynn T. M., Imasiku Mwiya, Bolton Paul A. Effectiveness of Trauma-Focused Cognitive Behavioral Therapy Among Trauma-Affected Children in Lusaka, Zambia. JAMA Pediatrics. 2015;169(8):761. doi: 10.1001/jamapediatrics.2015.0580.
    1. Bolton P, Bass J, Betancourt T, et al. Interventions for depression symptoms among adolescent survivors of war and displacement in northern Uganda: a randomized controlled trial. J Am Med Assoc. 2007;298(5):519–527. doi: 10.1001/jama.298.5.519.
    1. Bolton P, Bass J, Neugebauer R, et al. Group interpersonal psychotherapy for depression in rural Uganda: a randomized controlled trial. JAMA. 2003;289(23):3117. doi: 10.1001/jama.289.23.3117.
    1. Patel V, Weiss HA, Chowdhary N, et al. Effectiveness of an intervention led by lay health counsellors for depressive and anxiety disorders in primary care in Goa, India (MANAS): a cluster randomised controlled trial. Lancet. 2010;376(9758):2086–2095. doi: 10.1016/S0140-6736(10)61508-5.
    1. Weiss WM, Murray LK, Zangana GAS, et al. Community-based mental health treatments for survivors of torture and militant attacks in southern Iraq: a randomized control trial. BMC Psychiatry. 2015;15(1):249. doi: 10.1186/s12888-015-0622-7.
    1. Rahman A, Malik A, Sikander S, Roberts C, Creed F. Cognitive behaviour therapy-based intervention by community health workers for mothers with depression and their infants in rural Pakistan: a cluster-randomised controlled trial. Lancet. 2008;372(9642):902–909. doi: 10.1016/S0140-6736(08)61400-2.
    1. Bass J, Neugebauer R, Clougherty KF, et al. Group interpersonal psychotherapy for depression in rural Uganda: 6-month outcomes. Randomised controlled trial. Br J Psychiatry. 2006;188:567–573. doi: 10.1192/bjp.188.6.567.
    1. Murray LK, Skavenski S, Michalopoulos LM, et al. Counselor and client perspectives of trauma-focused cognitive behavioral therapy for children in Zambia: a qualitative study. J Clin Child Adolesc Psychol. 2014;43(6):1–13. doi: 10.1080/15374416.2013.859079.
    1. Padmanathan P, De Silva MJ. The acceptability and feasibility of task-sharing for mental healthcare in low and middle income countries: a systematic review. Soc Sci Med. 2013;97:82–86. doi: 10.1016/j.socscimed.2013.08.004.
    1. Eustache E, Gerbasi ME, Smith Fawzi MC, et al. Mental health training for secondary school teachers in Haiti: a mixed methods, prospective, formative research study of feasibility, acceptability, and effectiveness in knowledge acquisition. Glob Ment Heal. 2017;4. 10.1017/gmh.2016.29.
    1. Fairall L, Zwarenstein M, Thornicroft G. The applicability of trials of complex mental health interventions. In: Thornicroft G, Patel V, eds. Glob Ment Health Trials. Oxford, UK: Oxford University Press; 2014.
    1. Cohen JA, Mannarino AP, Deblinger E. Treating trauma and traumatic grief in children and adolescents. New York City, NY: Guilford Press; 2006.
    1. O’Donnell K, Dorsey S, Gong W, et al. Treating maladaptive grief and posttraumatic stress symptoms in orphaned children in Tanzania: group-based trauma-focused cognitive–behavioral therapy. J Trauma Stress. 2014;27(6):664–671. doi: 10.1002/jts.21970.
    1. Dorsey S, Lucid L, Martin P, et al Task-Shifted Trauma-focused Cognitive Behavioral Therapy for Children who Experienced Parental Death in Kenya and Tanzania: A Randomized Clinical Trial. JAMA Psychiatry (under review).
    1. Blume BD, Ford JK, Baldwin TT, Huang JL. Transfer of training: a meta-analytic review. J Manage. 2010;36(4):1065–1105.
    1. Baldwin TT, Ford JK. Transfer of training: a review and directions for future research. Pers Psychol. 1988;41(1):63–105. doi: 10.1111/j.1744-6570.1988.tb00632.x.
    1. Ford JK, Weissbein DA. Transfer of training: an updated review and analysis. Perform Improv Q. 1997;10(2):22–41. doi: 10.1111/j.1937-8327.1997.tb00047.x.
    1. Whetten K, Ostermann J, Whetten R, et al. More than the loss of a parent: potentially traumatic events among orphaned and abandoned children. J Trauma Stress. 2011;24(2):174–182. doi: 10.1002/jts.20625.
    1. Weiner BJ, Lewis MA, Linnan LA. Using organization theory to understand the determinants of effective implementation of worksite health promotion programs. Health Educ Res. 2009;24(2):292–305. doi: 10.1093/her/cyn019.
    1. Hemming K, Taljaard M, McKenzie JE, et al. Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration. BMJ. 2018;363. 10.1136/bmj.k1614.
    1. Chan A, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158:200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs. Med Care. 2012;50(3):217–226. doi: 10.1097/MLR.0b013e3182408812.
    1. Saldana L, Chamberlain P. Supporting implementation: the role of community development teams to build infrastructure. Am J Community Psychol. 2012;50(3):334–346. doi: 10.1007/s10464-012-9503-0.
    1. Hurlburt M, Aarons G, Fettes D, Willging C, Gunderson L, Chaffin M. Interagency collaborative team model for capacity building to scale-up evidence-based practice. Child Youth Serv Rev. 2014;39:160–168. doi: 10.1016/j.childyouth2013.10.005.
    1. National Council for Law Reporting (Kenya Law). Kenya Law: Laws on Devolution. Kenya Law. . Accessed 21 Nov 2019.
    1. Republic of Kenya. National Assembly Bills. The Mental Health Bill, 2014. Kenya Gazette Supplement No. 61 (National Assembly Bills No. 22). Nairobi, 22 April 2014.
    1. Ministry of Medical Services Republic of Kenya. The Mental Health Report. 2nd Draft. Nairobi, Kenya; 2012.
    1. Muraya J Kenya turns attention to mental health with new policy. AllAfrica. May 2016.
    1. Silverman WK, Ortiz CD, Viswesvaran C, et al. Evidence-based psychosocial treatments for children and adolescents exposed to traumatic events. J Clin Child Adolesc Psychol. 2008;37(1):156–183. doi: 10.1080/15374410701818293.
    1. Dorsey Shannon, McLaughlin Katie A., Kerns Suzanne E. U., Harrison Julie P., Lambert Hilary K., Briggs Ernestine C., Revillion Cox Julia, Amaya-Jackson Lisa. Evidence Base Update for Psychosocial Treatments for Children and Adolescents Exposed to Traumatic Events. Journal of Clinical Child & Adolescent Psychology. 2016;46(3):303–330. doi: 10.1080/15374416.2016.1220309.
    1. Deblinger E, Pollio E, Dorsey S. Applying trauma-focused cognitive–behavioral therapy in group format. Child Maltreat. 2016;21(1):59–73. doi: 10.1177/1077559515620668.
    1. Glasgow RE, Fisher L, Strycker LA, et al. Minimal intervention needed for change: definition, use, and value for improving health and health research. Transl Behav Med. 2014;4(1):26–33. doi: 10.1007/s13142-013-0232-1.
    1. UNICEF. Orphans. . Published 2017. Accessed 21 Nov 2019.
    1. Iwelunmor J, Blackstone S, Veira D, et al. Toward the sustainability of health interventions implemented in sub-Saharan Africa: a systematic review and conceptual framework. Implement Sci. 2016;11:43. doi: 10.1186/s13012-016-0392-8.
    1. Beidas RS, Kendall PC. Training therapists in evidence-based practice: a critical review of studies from a systems-contextual perspective. Clin Psychol Sci Pract. 2010;17(1):1–30. doi: 10.1111/j.1468-2850.2009.01187.x.
    1. Herschell AD, Kolko DJ, Baumann BL, Davis AC. The role of therapist training in the implementation of psychosocial treatments: a review and critique with recommendations. Clin Psychol Rev. 2010;30(4):448–466. doi: 10.1016/j.cpr.2010.02.005.
    1. Murray LK, Dorsey S, Bolton P, et al. Building capacity in mental health interventions in low resource countries: an apprenticeship model for training local providers. Int J Ment Health Syst. 2011;5(1):30. doi: 10.1186/1752-4458-5-30.
    1. Wiltsey Stirman S, Kimberly J, Cook N, et al. The sustainability of new programs and innovations: a review of the empirical literature and recommendations for future research. Implement Sci. 2012;7(1):17. doi: 10.1186/1748-5908-7-17.
    1. Whelan J, Love P, Pettman T, et al. Cochrane update: predicting sustainability of intervention effects in public health evidence: identifying key elements to provide guidance. J Public Health (Bangkok) 2014;36(2):347–351. doi: 10.1093/pubmed/fdu027.
    1. Shea CM, Jacobs SR, Esserman DA, Bruce K, Weiner BJ. Organizational readiness for implementing change: a psychometric assessment of a new measure. Implement Sci. 2014;9. 10.1186/1748-5908-9-7.
    1. Jacobs SR, Weiner BJ, Bunger AC. Context matters: measuring implementation climate among individuals and groups. Implement Sci. 2014;9. 10.1186/1748-5908-9-46.
    1. Bass B, Avolio B. MLQ: Multifactor leadership questionnaire (technical report). Binghamton: Binghamton University, Center for Leadership Studies; 1995.
    1. Aarons GA, Ehrhart MG, Farahnak LR. The implementation leadership scale (ILS): development of a brief measure of unit level implementation leadership. Implement Sci. 2014;9. 10.1186/1748-5908-9-45.
    1. Haroz EE, Bolton P, Nguyen AJ, et al. Measuring implementation in global mental health: validation of a pragmatic implementation science measure in eastern Ukraine using an experimental vignette design. BMC Health Serv Res. 2019;19(1):1–11. doi: 10.1186/s12913-019-4097-y.
    1. Weiner BJ, Lewis CC, Stanick C, et al. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017;12(1):1–12. doi: 10.1186/s13012-017-0635-3.
    1. Huijg JM, Gebhardt WA, Crone MR, Dusseldorp E, Presseau J. Discriminant content validity of a theoretical domains framework questionnaire for use in implementation research. Implement Sci. 2014;9(1):1–16. doi: 10.1186/1748-5908-9-11.
    1. Huijg JM, Gebhardt WA, Dusseldorp E, et al. Measuring determinants of implementation behavior: psychometric properties of a questionnaire based on the theoretical domains framework. Implement Sci. 2014;9(1):1–15. doi: 10.1186/1748-5908-9-33.
    1. Palinkas LA. Qualitative and mixed methods in mental health services and implementation research. J Clin Child Adolesc Psychol. 2014;43(6):851–861. doi: 10.1080/15374416.2014.910791.
    1. Klein KJ, Sorra JS. The challenge of innovation implementation. Acad Manag Rev. 1996;21(4):1055–1080. doi: 10.5465/AMR.1996.9704071863.
    1. Thiem A. Unifying Configurational comparative methods: generalized-set qualitative comparative analysis. Sociol Methods Res. 2014;43(2):313–337. doi: 10.1177/0049124113500481.
    1. Ragin CC. Redesigning Soc Inq: University of Chicago Press Chicago; 2008.
    1. Rihoux B, Ragin CC, eds. Configurational Comparative Methods: Qualitative Comparative Analysis (QCA) and Related Techniques. Sage; 2009.
    1. McAlearney AS, Walker D, Moss AD, Bickell NA. Using qualitative comparative analysis (QCA) of key informant interviews in health services research: enhancing a study of adjuvant therapy use in breast cancer care. Med Care. 2016;54(4):400–405. doi: 10.1097/MLR.0000000000000503.
    1. Kane H, Lewis M, Williams P, Kahwati L. Using qualitative comparative analysis to understand and quantify translation and implementation. Transl Behav Med. 2014;4(2):201–208. doi: 10.1007/s13142-014-0251-6.
    1. Ragin CC. Fuzzy-Set Soc Sci: University of Chicago Press; 2000.
    1. Longest KC, Thoits PA. Gender, the stress process, and health: a configurational approach. Soc Ment Health. 2012;2(3):187–206. doi: 10.1177/2156869312451151.
    1. Baumgartner M. Detecting causal chains in small-n data. Field Methods. 2013;25(1):3–24. doi: 10.1177/1525822X12462527.
    1. Goertz G, Mahoney J. Two-level theories and fuzzy-set analysis. Sociol Methods Res. 2005;33(4):497–538. doi: 10.1177/0049124104266128.
    1. Wagemann C, Schneider C. Qualitative comparative analysis (QCA) and fuzzy-sets: agenda for a research approach and a data analysis technique. Comp Sociol. 2010;9(3):376–396. doi: 10.1163/156913210X12493538729838.
    1. Edwards F. The Principles of Switching Circuits. Cambridge: Massachusetts Institute of Technology Press; 1973.
    1. Thiem A. Conducting Configurational comparative research with qualitative comparative analysis: a hands-on tutorial for applied evaluation scholars and practitioners. Am J Eval. 2017;38(3):420–433. doi: 10.1177/1098214016673902.
    1. Schneider CQ, Wagemann C. Set-Theor Methods Soc Sci. Cambridge, United Kingdom: Cambridge University Press; 2012. doi:10.1017/cbo9781139004244.
    1. Baumgartner Michael, Thiem Alrik. Model Ambiguities in Configurational Comparative Research. Sociological Methods & Research. 2015;46(4):954–987. doi: 10.1177/0049124115610351.
    1. Thiem A. Navigating the complexities of qualitative comparative analysis: case numbers, necessity relations, and model ambiguities. Eval Rev. 2014;38(6):487–513. doi: 10.1177/0193841X14550863.
    1. Baumgartner M, Thiem A. Often trusted but never (properly) tested: evaluating qualitative comparative analysis. Sociol Methods Res. 2017:1–33. 10.1177/0049124117701487.
    1. Hussey MA, Hughes JP. Design and analysis of stepped wedge cluster randomized trials. Contemp Clin Trials. 2007;28(2):182–191. doi: 10.1016/j.cct.2006.05.007.
    1. Kasza Jessica, Forbes Andrew B. Inference for the treatment effect in multiple-period cluster randomised trials when random effect correlation structure is misspecified. Statistical Methods in Medical Research. 2018;28(10-11):3112–3122. doi: 10.1177/0962280218797151.
    1. Thompson JA, Fielding KL, Davey C, Aiken AM, Hargreaves JR, Hayes RJ. Bias and inference from misspecified mixed-effect models in stepped wedge trial analysis. Stat Med. 2017;36(23):3670–3682. doi: 10.1002/sim.7348.
    1. Fiero MH, Hsu C, Bell ML. A pattern-mixture model approach for handling missing continuous outcome data in longitudinal cluster randomized trials. Stat Med. 2018;36(26):4094–4105. doi: 10.1002/sim.7418.A.
    1. Hemming K, Girling A. The efficiency of stepped wedge vs. cluster randomized trials: stepped wedge studies do not always require a smaller sample size. J Clin Epidemiol. 2013;66(12):1427–1428. doi: 10.1016/j.jclinepi.2013.07.007.
    1. Woertman W, De Hoop E, Moerbeek M, Zuidema SU, Gerritsen DL, Teerenstra S. Stepped wedge designs could reduce the required sample size in cluster randomized trials. J Clin Epidemiol. 2013;66(7):752–758. doi: 10.1016/j.jclinepi.2013.01.009.
    1. The Shiny CRT Calculator: Power and Sample size for Cluster Randomised Trial. . Accessed 6 Oct 2019.
    1. Hemming K, Lilford R, Girling AJ. Stepped-wedge cluster randomised controlled trials: a generic framework including parallel and multiple-level designs. Stat Med. 2015;34(2):181–196. doi: 10.1002/sim.6325.
    1. Girling AJ, Hemming K. Statistical efficiency and optimal design for stepped cluster studies under linear mixed effects models. Stat Med. 2016;35(13):2149–2166. doi: 10.1002/sim.6850.
    1. Hooper R., Bourke L. Cluster randomised trials with repeated cross sections: alternatives to parallel group designs. BMJ. 2015;350(jun08 8):h2925–h2925. doi: 10.1136/bmj.h2925.
    1. Kasza J, Hemming K, Hooper R, Matthews JNS, Forbes AB. Impact of non-uniform correlation structure on sample size and power in multiple-period cluster randomised trials. Stat Methods Med Res. 2019;28(3):703–716. doi: 10.1177/0962280217734981.

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