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Building and Sustaining Interventions for Children: Task-sharing Mental Health Care in Low-resource Settings (BASIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03243396
Recruitment Status : Enrolling by invitation
First Posted : August 9, 2017
Last Update Posted : September 23, 2021
Sponsor:
Collaborators:
University of Washington
Johns Hopkins University
Ace Africa
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Duke University

Brief Summary:
The BASIC study will take place in Kanduyi/Bungoma South Sub-County, in western Kenya, and focuses on children orphaned by one or two parents. Growing evidence demonstrates that orphaned children in low- and middle-income countries are at higher risk of mental health problems, but mental health professionals are largely unavailable in this area. Research suggests that some mental health treatments can be delivered effectively in low- and middle-income countries using a task-shifting approach, in which lay counselors with little or no prior mental health experience are trained to provide treatment, and deliver with supervision. However, very little is known about how to support local systems and organizations in delivering mental health care via task-shifting, particularly in a way that could scale-able and sustainable in the low-resource context. The BASIC team's prior work suggests that partnering with two government sectors, education and health, could be a low-cost and sustainable strategy to implement task-shifted mental health services. By training teachers (via the Education sector) and community health volunteers (via the Health sector) to provide mental health care, a larger population could potentially be reached. Before attempting any country or system-wide implementation, it is important to know what is needed to enable successful implementation in either or both sectors, client outcomes for those receiving mental health care when delivered via Education or Health, and cost of delivery in both sectors. The team aims to collect outcomes that are relevant to policy makers, and that can be considered along with cost and experiences in both sectors.

Condition or disease Intervention/treatment Phase
Grief Post Traumatic Stress Disorder Depression Behavioral: Trauma-Focused Cognitive Behavioral Therapy Not Applicable

Detailed Description:

Building and Sustaining Interventions for Children (BASIC): Task-sharing mental health care in low-resource settings builds on our 15-year history of collaborations with research partners in Kenya, prior NIH-funded work that identified mental health needs of orphaned children in low- and middle-income countries, and iterative and collaborative intervention adaptation and testing using a task-sharing approach, to address these needs.Our goal is to identify locally sustainable implementation policies and practices (IPPs) that lead to effective implementation of task-shared evidence-based treatment (EBT) delivery (a locally adapted version of Trauma-focused Cognitive Behavioral Therapy (TF-CBT), Pamoja Tunaweza in this study) in 2 governmental sectors in Kenya. Both sectors were identified by our Kenyan partners as potential platforms for scale- up-Education via teacher delivery and Health via community health volunteer (CHV) delivery. Both Education and Health may be viable sectors for mental health care delivery, but the IPPs that predict implementation success and intervention effectiveness in either/ both sectors are unknown. This study identifies con-textually relevant, practical, and actionable IPPs that can inform implementation planning, while also assessing child outcomes and intervention costs in both sectors.

The recent devolvement of the Kenyan government (leading to more local decision-making), the launch of a National Mental Health Policy, and our Kenyan partners' empowerment work building enthusiasm for TF-CBT are converging to create a local climate in which BASIC could become part of the county plan, if evidence-based guidance for implementation, using mostly existing resources, existed. The trial design is an incomplete stepped wedge cluster randomized controlled trial (SW-CRT) including 40 schools and the 40 surrounding villages. The school and the surrounding community are considered a "village cluster." Each of the 40 "village clusters" has 1 team of teachers and 1 team of CHVs delivering Pamoja Tunaweza, resulting in 120 trained lay counselors in each sector, who provide TF-CBT to 1,280 youth and one of their guardians, across seven sequences of the SW-CRT. Site leaders are enrolled for data collection (up to 80), but do not provide services. The study uses a novel method, qualitative comparative analyses (QCA), that holds potential for substantially advancing the field of implementation science. QCA leverages the rigor of quantitative approaches and the detail of qualitative approaches, and allows for complex causality and equifinality (i.e., an outcome can be reached by multiple means).

Study aims are: 1) Identify actionable IPPs that predict adoption (delivery) and fidelity (high- quality delivery) after 10 sites in each sector implement TF-CBT (sequence 1). Use identified IPPs to (Aim 1a) guide implementation planning support for subsequent sites and to (Aim 1b) generate testable hypotheses about IPPs as causal mechanisms; 2) Test mechanisms of implementation success in both sectors across all 7 sequences; and 3) Test TF-CBT effectiveness (i.e., mental health outcomes; functioning) and cost in both sectors. This research has important implications for implementing an evidence-based treatment in low-resource settings, including the US.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2880 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Child mental health outcomes are assessed using an incomplete stepped wedge, cluster randomized controlled trial with 7 sequences. Child participants & one guardian each are randomized to receive the treatment (therapy sessions) from lay counselors in the Health (Community Health Volunteer) or Education (teacher) sector, with timing based on the sequence to which their village cluster was randomly assigned. These participants are the focus of the Interventional Study Design in Aim 3. Also included are lay counselors & site leaders (Head Teachers, Deputy Teachers, & Community Health Extension Workers), given that it is a hybrid effectiveness-implementation trial. These participants, the focus of implementation questions in Aims 1 & 2, provide TF-CBT & do not receive therapy sessions themselves. The village clusters are randomized to sequences in the SW-CRT, & if randomized to sequences 2-7, they receive coaching support informed by sequence 1 on how to effectively implement TF-CBT.
Masking: None (Open Label)
Masking Description: No masking--Child/Adolescent participants and their participating guardian will be able to tell to which arm they were allocated or randomized, given that they know from whom they receive treatment (from teachers, indicating Education or from Community Health Volunteers, indicating Health). There are other participant types in addition to children/adolescents and guardians who are enrolled in BASIC (per above description) to answer implementation questions (Aims 1 and 2 of BASIC). As noted above, these other participants include the lay counselors (teachers and Community Health Volunteers, their site leaders [Education: Head Teachers and Deputy Teachers; Health: Community Health Extension Workers]).
Primary Purpose: Treatment
Official Title: Building and Sustaining Interventions for Children (BASIC): Task-sharing Mental Health Care in Low-resource Settings
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Health-Sector Delivered CBT
These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers.
Behavioral: Trauma-Focused Cognitive Behavioral Therapy
Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).
Other Name: Pamoja Tunaweza

Experimental: Education-Sector Delivered CBT
These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school.
Behavioral: Trauma-Focused Cognitive Behavioral Therapy
Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).
Other Name: Pamoja Tunaweza




Primary Outcome Measures :
  1. Change in Posttraumatic Stress Symptoms (child report) [ Time Frame: Baseline, End of 8-session Treatment (assessed up to 18 weeks) ]
    Severity of posttraumatic stress symptoms, as assessed by the Child and Adolescent Trauma Screen (child report). Higher scores represent more severe symptoms.

  2. Fidelity [ Time Frame: End of first year of site implementation (2 groups, 8 sessions each) ]
    Ability of the group leader to adhere to established Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) protocols and guidelines, as assessed by the Fidelity and Adherence Rating Scales developed by the study team. Assessed in each observed TF-CBT session by supervisors. Higher scores represent higher fidelity and adherence to TF-CBT.

  3. Adoption [ Time Frame: End of first year of site implementation (2 groups, 8 sessions each) ]
    Adoption is is a binary yes/no outcome defined as delivery of 2 on-site 8-session TF-CBT groups by a 3-counselor team and is measured by counselor self-report (and confirmed by supervisors). Assessed for each "trimester" end for schools and communities, summarized over the year.

  4. Sustainment [ Time Frame: Two years after the first TF-CBT groups for each site ]
    Sustainment is a binary yes/no outcome defined as maintained delivery 2 years after the study intervention period (2 groups delivered within a calendar year, with at least 80% capacity as compared to their group enrollment during initial implementation). It is measured by counselor self-report (and confirmed by supervisors).


Secondary Outcome Measures :
  1. Change in Posttraumatic Stress Symptoms (caregiver report) [ Time Frame: Baseline, End of 8-session Treatment (assessed up to 18 weeks) ]
    Severity of posttraumatic stress symptoms, as assessed by the Child and Adolescent Trauma Screen (caregiver report). Higher scores represent more severe symptoms.

  2. Change in Depressive Symptoms (child report) [ Time Frame: Baseline, End of 8-session Treatment (assessed up to 18 weeks) ]
    Level of experienced depressive symptoms, as assessed by the Adolescent version of the Patient Health Questionnaire (8-question version). Higher scores represent more severe symptoms.

  3. Change in Grief (child report) [ Time Frame: Baseline, End of 8-session Treatment (assessed up to 18 weeks) ]
    Level of grief related to a traumatic event experienced by the child, as assessed by the Inventory of Complex Grief. Higher scores represent more severe symptoms.

  4. TF-CBT Knowledge [ Time Frame: Immediately Post-Training (on final day of training) ]
    Test of the level of knowledge of the group leader about TF-CBT, as assessed by the TF-CBT Knowledge Assessment. Higher scores represent greater group leader knowledge of TF-CBT.

  5. Prosocial Behavior (child report) [ Time Frame: End of 8-session Treatment (assessed up to 18 weeks) ]
    Behavioral strengths of the child, as assessed by the Prosocial Behavior subscale of the Strengths and Difficulties Questionnaire. Higher scores represent more prosocial behavior.

  6. Behavioral Difficulties (guardian report) [ Time Frame: End of 8-session Treatment (assessed up to 18 weeks) ]
    Behavioral difficulties of the child, as assessed by the Conduct Problems subscale of the Strengths and Difficulties Questionnaire. Higher scores represent more abnormal symptoms.

  7. School Attendance [ Time Frame: At study completion, average 1.5 years ]
    School attendance measured by the number of school days missed in the past two weeks, as reported by the guardian.

  8. Child Labor [ Time Frame: At study completion, average 1.5 years ]
    Hours of paid labor required of the child in the past week, as assessed by the Child Work and Labor Questionnaire. UNICEF's definition of excessive labor for children aged 12 and older is 14 hours per week for pay and 28 hours per week with or without pay.

  9. Household Assistance [ Time Frame: At study completion, average 1.5 years ]
    Hours of chores (non-income generating work around the home) required of the child in the past week, as reported by the child.

  10. Safer Sex Peer Norms [ Time Frame: At study completion, average 1.5 years ]
    Agreement exhibited by the child with positive peer norms regarding sexual behavior, as assessed by the Safer Sex Peer Norms subscale on the Safer Sex Peer Norms and Substance Use Questionnaire. Higher scores represent stronger agreement with positive peer norms. This measure is only administered at any follow up (usually the 2nd or 3rd-year) if the participant is 16 or older.

  11. Substance Use [ Time Frame: At study completion, average 1.5 years ]
    Substance use is a binary yes/no outcome defined as any alcohol, tobacco, or other drug use reported by the child, as assessed by the Substance Use subscale on the Safer Sex Peer Norms and Substance Use Questionnaire.


Other Outcome Measures:
  1. Relationship Closeness [ Time Frame: End of 8-session Treatment (assessed up to 18 weeks) ]
    Closeness of the child's relationship with their caregiver, as assessed by caregiver report in the Closeness subscale of the Child-Parent Relationship Scale. Higher scores represent greater closeness.

  2. Relationship Conflict [ Time Frame: End of 8-session Treatment (assessed up to 18 weeks) ]
    Conflict in the child's relationship with their caregiver, as assessed by caregiver report in the Conflict subscale of the Child-Parent Relationship Scale. Higher scores represent more conflict.

  3. Guardian-provided Social Support [ Time Frame: End of 8-session Treatment (assessed up to 18 weeks) ]
    Social support provided to the child by their parent or guardian, as assessed by child report in the Child and Adolescent Social Support Scale. Higher scores represent more support.

  4. Intervention Acceptability [ Time Frame: End of first year of site implementation (2 groups, 8 sessions each) ]
    Assessed using both reflective and formative measures at the group leader level. The reflective measure is the Acceptability of Intervention Measure (AIM), with scores ranging from 1 (least acceptable) to 5 (most acceptable) calculated as a mean score to reflect the acceptability of the TF-CBT intervention in a given setting. The formative measure is the Johns Hopkins University (JHU) Implementation science case for Acceptability (using only 5 items that mapped directly onto Proctor's definition of acceptability and did not overlap with items on the AIM measure). This is not treated as a scale, and items are analyzed independently of each other.

  5. Intervention Feasibility [ Time Frame: End of first year of site implementation (2 groups, 8 sessions each) ]
    Assessed using both reflective and formative measures at the group leader level. The reflective measure is the Feasibility of Intervention Measure (FIM), with scores ranging from 1 (least feasible) to 5 (most feasible) calculated as a mean score to reflect the feasibility of implementing TF-CBT in a given setting. The formative measure is the Johns Hopkins University Implementation science scale for Feasibility (using 12 items). This is not treated as a scale, and items are analyzed independently of each other. 2 additional items were included that inquired about the estimated hours per week that respondents felt Pamoja Tunaweza/TF-CBT would require, given the importance of this information for understanding added workload and feasibility for providers in the two contexts ("On average, how many hours per week do you spend on Pamoja Tunaweza/TF-CBT [e.g., preparing for sessions, delivering sessions, and supervision]?").

  6. Intervention Appropriateness [ Time Frame: End of first year of site implementation (2 groups, 8 sessions each) ]
    A formative measure is used to assess perceived appropriateness of the TF-CBT intervention at the group leader level, with scores ranging from 1 (least appropriate) to 5 (most appropriate). This is not treated as a scale, and items are analyzed independently of each other. Six items were adapted from the Johns Hopkins University implementation measures that aligned with Proctor and colleagues' (20) definition of appropriateness. Minor changes were made to fit wording to the local context. Two additional items were developed to measure appropriateness domain content for which Johns Hopkins University items did not exist. Given challenges in creating new items, Hujig's Theoretical Domains Framework was used when possible to guide item creation (42). In the resulting 8-item measure, 4 items assessed the perceived fit of delivering TF-CBT with one's role. The additional 4 items assessed the perceived fit of delivering TF-CBT within the specific setting.



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child or young adolescent between the ages of 11 and 14 at the time of enrollment
  • Child lost one or both parents to death at least 6 months ago or later, and when the child was 4 years old or older
  • Child lives in the community with at least one adult guardian (18 years old or older)
  • Child is experiencing borderline or clinically significant levels of post-traumatic stress or childhood traumatic grief (as indicated by a score of 18 or higher on the Child Posttraumatic Stress Scale, or a score of 35 or higher on the Inventory of Complicated Grief)

Exclusion Criteria:

  • Child has a known developmental or cognitive disability
  • Child attends private school
  • Child and family are about to move
  • Children who lost a parent less than 6 months ago (since they may be experiencing a normal grief reaction and may not necessarily be in need of the treatment for CTG)
  • Caregiver of the child refuses to participate
  • Lay counselor is not literate
  • Lay counselor does not have a mobile phone
  • Lay counselor refuses to serve as a counselor
  • Site leader refuses to allow their site to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243396


Locations
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Kenya
ACE Africa
Bungoma, Bungoma County, Kenya
Sponsors and Collaborators
Duke University
University of Washington
Johns Hopkins University
Ace Africa
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Kathryn Whetten, PhD Center for Health Policy and Inequalities Research at Duke University
Principal Investigator: Shannon Dorsey, PhD University of Washington Department of Psychology
  Study Documents (Full-Text)

Documents provided by Duke University:
Publications:
Dranove D. Measuring cost. In: Sloan F, ed. Valuing Health Care: Costs, Benefits and Effectiveness. Cambridge University Press; 1995.
Haddix AC, Teutsch SM, Corso PS, eds. Prevention Effectiveness: A Guide to Decision Analysis and Economic Evaluation. 2nd ed. Oxford University Press; 2002.
Little R, Rubin D. Statistical Analysis with Missing Data. New York: Wiley; 2002.
World Health Organization. Beginning with the end in mind: planning pilot projects and other programmatic research for successful scaling up. http://www.who.int/reproductivehealth/publications/strategic_approach/9789241502320/en/. Accessed May 24, 2016.
Yin RK. Case Study Research: Design and Methods. Vol 5. Thousand Oaks, CA: SAGE Publications, Inc.; 2009.
Trochim WMK. Research Methods Knowledge Base. 2nd ed. Mason, OH: Atomic Dog Publishing; 2001.
Miles MB, Huberman AM. Qualitative Data Analysis: An Expanded Sourcebook. SAGE; 1994.
Yin RK. Changing Urban Bureaucracies: How New Practices Become Routinized. Lexington, MA: Lexington Books; 1979.
Brownson RC, Colditz GA, Proctor EK, eds. Dissemination and Implementation Research in Health: Translating Science to Practice. 1st ed. Oxford, UK: Oxford University Press; 2012.
Beebe J. Rapid Qualitative Inquiry: A Field Guide to Team-Based Assessment. 2nd ed. Lanham, Maryland: Rowman & Littlefield; 2014.
Belden CM, Weiner BJ. A fuzzy set analysis of implementation strategies promoting minority participation in cancer clinical trials. under review.
Ferlie E, Fitzgerald L, Wood M, Hawkins C. The Nonspread of Innovations: The Mediating Role of Professionals. The Academy of Management Journal. 2005;48(1):117-134. doi:10.2307/20159644.
Van de Ven AH, Polley DE, Garud R, Venkataraman S. The Innovation Journey.; 1999. http://library.wur.nl/WebQuery/clc/1882056. Accessed May 9, 2016.
Goertz G, Mahoney J. Two-level theories and fuzzy-set analysis. Sociological Methods & Research. 2005;33(4):497-538. doi:10.1177/0049124104266128.
Longest KC, Thoits PA. Gender, the stress process, and health: A configurational approach. Society and Mental Health. 2012;2(3):187-206. doi:10.1177/2156869312451151.
Ragin CC. Fuzzy-Set Social Science. University of Chicago Press; 2000.
Ragin CC. Redesigning Social Inquiry: Fuzzy Sets and Beyond. University of Chicago Press Chicago; 2008.
Avdagic S. When are concerted reforms feasible? Explaining the emergence of social pacts in Western Europe. Comparative Political Studies. 2010;42:628-657.
Weiner DA, Schneider A, Lyons JS. Evidence-based treatments for trauma among culturally diverse foster care youth: Treatment retention and outcomes. Children and Youth Services Review. 2009;31:1199- 1205.
Ford JK, Weissbein DA. Transfer of training: An updated review and analysis. Performance Improvement Quarterly. 1997;10(2):22-41.
Blume BD, Ford JK, Baldwin TT, Huang JL. Transfer of training: A meta-analytic Review. Journal of Management. 2010;36(4):1065-1105.
Baldwin TT, Ford JK. Transfer of training: A review and directions for future research. Personnel Psychology. 1988;41(1):63-105.
UNICEF. Primary School Years: The Children - Kenya. http://www.unicef.org/kenya/children_3795.htm. Accessed May 25, 2016.
World Bank. Data: Population, ages 0-14 (% of total). http://data.worldbank.org/indicator/SP.POP.0014.TO.ZS. Accessed May 25, 2016.
Index Mundi. Kenya Demographics Profile 2014. http://www.indexmundi.com/kenya/demographics_profile.html. Accessed May 26, 2016.
Ministry of Medical Services, Republic of Kenya. The Mental Health Report. 2nd Draft. Nairobi, Kenya; 2012.
Kenyan National Assembly. Mental Health Bill.; 2014.
World Bank. Kenya's Devolution. http://www.worldbank.org/en/country/kenya/brief/kenyas-devolution. Accessed May 25, 2016.
National Council for Law Reporting (Kenya Law). Kenya Law: Laws on Devolution. Kenya Law. http://kenyalaw.org/kl/index.php?id=3979. Accessed May 25, 2016.
UNICEF. Kenya Statistics. http://www.unicef.org/infobycountry/kenya_statistics.html. Accessed April 24, 2016.
UNICEF. State of the World's Children: Statistical Tables.; 2015.
UNICEF. Africa's Orphaned and Vulnerable Generations: Children Affected by AIDS. Author; 2006. 5/25/2016.
Orphans. UNICEF. http://www.unicef.org/media/media_45279.html. Accessed May 25, 2016.
Institute of Medicines of the National Academies. Evaluation of PEPFAR. Washington, D.C.: National Academies Press; 2013. http://www.nap.edu/catalog/18256. Accessed May 25, 2016.
Muraya J. Kenya Turns Attention to Mental Health With New Policy. AllAfrica. http://allafrica.com/stories/201605181158.html. Published May 18, 2016. Accessed May 30, 2016.
World Health Organization. Mental Health Action Plan: 2013-2020. Geneva, Switzerland: Author; 2013.
Fairall L, Zwarenstein M, Thornicroft G. The applicability of trials of complex mental health interventions. In: Thornicroft G, Patel V, eds. Global Mental Health Trials. Oxford, UK: Oxford University Press; 2014.
World Health Organization. Mental Health Atlas 2011. 2011. http://www.who.int/mental_health/publications/mental_health_atlas_2011/en/.
World Health Organization. Global Burden of Disease Report: 2004 Update. Geneva, Switzerland: Author; 2008.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03243396    
Other Study ID Numbers: Pro00081913
1R01MH112633 ( U.S. NIH Grant/Contract )
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: September 23, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Mental health
Cognitive behavioral therapy
Task-shifting
Global health
Teacher
Community health volunteer
Children
Orphans
Abandoned children
TF-CBT
Mental health policy
Ministry of Education
Ministry of Health
Delivery
Implementation science
Qualitative comparative analysis
Implementation practices and policies
Youth
Adoption
Fidelity
Kenya
Bungoma
Kanduyi
West Africa
Posttraumatic stress
Childhood traumatic grief
Grief
Trauma
Task-sharing
Global mental health
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders