IMPORTANCE Approximately 140 million children worldwide have experienced the death of one or both parents. These children, mostly in low-and middle-income countries, have higher rates of mental health problems than those who have not experienced parental death. Cognitive behavioral therapy (CBT) may improve the well-being of these children, but to our knowledge there have been no randomized clinical trials specifically focused on this population.OBJECTIVES To test the effectiveness of trauma-focused CBT (TF-CBT) for improving posttraumatic stress (PTS) in children in Kenya and Tanzania who have experienced parental death, to test the effects of TF-CBT on other mental health symptoms, and to examine the feasibility of task-shifting with greater reliance on experienced, local lay counselors as trainers and supervisors. DESIGN, SETTING, AND PARTICIPANTSA randomized clinical trial conducted in urban and rural areas of Tanzania and Kenya compared TF-CBT and usual care (UC) for 640 children aged 7 to 13 years who were recruited from February 13, 2013, to July 24, 2015. All children had experienced the death of one or both parents and had elevated PTS and/or prolonged grief. Interviewers were masked to study condition. Participants were followed up for 12 months after the randomized clinical trial. Statistical analysis was performed from February 3, 2017, to August 26, 2019. All analyses were on an intent-to-treat basis. INTERVENTIONSIn the intervention condition, 320 children received 12 weeks of group TF-CBT delivered by lay counselors who were supervised weekly. In the UC condition, 320 children received community services typically offered to this population. MAIN OUTCOMES AND MEASURESThe primary outcome was PTS, evaluated using a continuous, standardized measure. Other mental health symptoms and child-guardian relationship were also measured. RESULTS A total of 640 children (320 girls and 320 boys; mean [SD] age, 10.6 [1.6] years) were included in the study. Trauma-focused CBT was more effective than UC for PTS in 3 of 4 sites after treatment (end of 3-month randomized clinical trial): rural Kenya (Cohen d = 1.04 [95% CI, 0.72-1.36]), urban Kenya (Cohen d = 0.56 [95% CI, 0.29-0.83]), and urban Tanzania (Cohen d = 0.45 [95% CI, 0.10-0.80]). At 12-month follow-up, TF-CBT remained more effective than UC in both rural (Cohen d = 0.86 [95% CI, 0.64-1.07]) and urban (Cohen d = 0.99 [95% CI, 0.75-1.23]) Kenya. At 12-month follow-up in Tanzania, children who received TF-CBT and UC had comparable rates of improvement (rural Tanzania, Cohen d = 0.09 [95% CI, −0.08 to 0.26]; urban Tanzania, Cohen d = 0.11 [95% CI, −0.09 to 0.31]).A similar pattern was seen for secondary outcomes, with stronger effects observed in Kenya, where children experienced greater stress and adversity (eg, more food scarcity, poorer guardian health, and greater exposure to traumatic events).CONCLUSIONS AND RELEVANCE This study found that TF-CBT was more effective than UC in reducing PTS among children who experienced parental death in 3 of 4 sites in K...

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 Traumafocused 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.

Background First-level leadership is uniquely positioned to support evidence-based practice (EBP) implementation for behavioral health due to first-level leaders’ access to and relationship with service providers. First-level leaders are individuals who directly supervise and manage frontline employees who do not manage others. However, first-level leadership is underrepresented in existing reviews of the impact of leadership on EBP implementation. This review describes the relationship between first-level leadership and implementation determinants and outcomes. Methods A scoping review was performed to synthesize the literature on the relationship between first-level leadership and inner-context and implementation outcomes. A literature search was conducted in PubMed, Eric, PsycINFO, CINAHL, Scopus, and Web of Science. To be eligible, studies had to examine first-level leadership, be conducted in settings providing behavioral health services, and examine the relationship between first-level leadership and an implementation or inner-context outcome. Data extraction and synthesis were performed to describe study characteristics, leader-outcome relationships, and overlap in leadership frameworks. Results Twenty-one records met our inclusion criteria. Studies primarily relied on observational designs and were often cross-sectional. Studies more often examined general leadership rather than leadership strategically focused on EBP implementation (i.e., strategic implementation leadership). Our findings suggest that several forms of first-level leadership are inconsistently related to a broad set of implementation determinants, with infrequent examination of specific implementation outcomes. The broad set of implementation determinants studied, limited number of replications, and inconsistent findings have resulted in sparse evidence for any specific leadership-outcome relationship. The greatest accumulation of evidence exists for general leadership’s positive relationship with providers’ EBP attitudes, most notably in the form of transformational leadership. This was followed by evidence for strategic implementation leadership facilitating general implementation. Our synthesis revealed moderate conceptual overlap of strategic implementation leadership behaviors described in the theory of implementation leadership and theory of middle managers’ role in implementation. Conclusions Our findings suggest that first-level leadership may play an important role in shaping implementation determinants and outcomes, but consistent empirical support is sparse and confidence dampened by methodological issues. To advance the field, we need studies that adopt stronger methodological rigor, address the conceptual overlap in leadership frameworks, examine a broader set of implementation outcomes, and examine conditions under which leadership impacts implementation. Trial registration This review was not registered.