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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Grief, Post Traumatic Stress Disorder, Depression

Intervention / Treatment
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* Behavioral: Trauma-Focused Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Health-Sector Delivered CBT<br>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<br>* 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).<br>* Other names: Pamoja Tunaweza;|
| Experimental: Education-Sector Delivered CBT<br>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<br>* 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).<br>* Other names: Pamoja Tunaweza;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Posttraumatic Stress Symptoms (child report) | Severity of posttraumatic stress symptoms, as assessed by the Child and Adolescent Trauma Screen (child report). Higher scores represent more severe symptoms. | Baseline, End of 8-session Treatment (assessed up to 18 weeks) | 
| Fidelity | 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. | End of first year of site implementation (2 groups, 8 sessions each) | 
| Adoption | 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. | End of first year of site implementation (2 groups, 8 sessions each) | 
| Sustainment | 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). | Two years after the first TF-CBT groups for each site | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Posttraumatic Stress Symptoms (caregiver report) | Severity of posttraumatic stress symptoms, as assessed by the Child and Adolescent Trauma Screen (caregiver report). Higher scores represent more severe symptoms. | Baseline, End of 8-session Treatment (assessed up to 18 weeks) | 
| Change in Depressive Symptoms (child report) | 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. | Baseline, End of 8-session Treatment (assessed up to 18 weeks) | 
| Change in Grief (child report) | 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. | Baseline, End of 8-session Treatment (assessed up to 18 weeks) | 
| TF-CBT Knowledge | 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. | Immediately Post-Training (on final day of training) | 
| Prosocial Behavior (child report) | Behavioral strengths of the child, as assessed by the Prosocial Behavior subscale of the Strengths and Difficulties Questionnaire. Higher scores represent more prosocial behavior. | End of 8-session Treatment (assessed up to 18 weeks) | 
| Behavioral Difficulties (guardian report) | Behavioral difficulties of the child, as assessed by the Conduct Problems subscale of the Strengths and Difficulties Questionnaire. Higher scores represent more abnormal symptoms. | End of 8-session Treatment (assessed up to 18 weeks) | 
| School Attendance | School attendance measured by the number of school days missed in the past two weeks, as reported by the guardian. | At study completion, average 1.5 years | 
| Child Labor | 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. | At study completion, average 1.5 years | 
| Household Assistance | Hours of chores (non-income generating work around the home) required of the child in the past week, as reported by the child. | At study completion, average 1.5 years | 
| Safer Sex Peer Norms | 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. | At study completion, average 1.5 years | 
| Substance Use | 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. | At study completion, average 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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