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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
956
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).
ACE Africa
Bungoma, Bungoma County, Kenya
Change in Posttraumatic Stress Symptoms (Child Report)
Severity of posttraumatic stress symptoms, as assessed by the Child and Adolescent Trauma Screen (child report), including additional items validated locally. Higher scores represent more severe symptoms. The range of scores is 0 to 66. Scores are the sum of 22 items asking about how often specific things have bothered someone in the past 4 weeks. Each item is measured on a scale of 0 to 3, where 0=never happens and 3=almost always.
Time frame: 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 adherence to TF-CBT. Adherence is measured on a scale of 0 to 6. Scores reported are observations of Child groups.
Time frame: End of first year of site implementation (2 groups, 8 sessions each)
Number of Sites That Adopted the Intervention
Adoption is a binary yes/no outcome defined as initiating and delivering the 8-session TF-CBT groups by a 3-counselor team and is measured by counselor self-report (and confirmed by supervisors who observed groups). Assessed for each "trimester" end for schools and communities, summarized over the year. We report the number of sites out of 40 total that adopted the intervention.
Time frame: End of first year of site implementation (2 groups, 8 sessions each)
Number of Sites That Sustained the Intervention
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). At times the number of youth that would be 80% enrolled required rounding down to the nearest whole person. We report the number of sites out of 40 total that sustained the intervention.
Time frame: Two years after the first TF-CBT groups for each site
Change in Posttraumatic Stress Symptoms (Caregiver Report)
Severity of posttraumatic stress symptoms, as assessed by the Child and Adolescent Trauma Screen (caregiver report), including additional items validated locally. Higher scores represent more severe symptoms. The range of scores is 0 to 66. Scores are the sum of 22 items asking about how often specific things have bothered someone in the past 4 weeks. Each item is measured on a scale of 0 to 3, where 0=never happens and 3=almost always.
Time frame: 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) and additional items validated locally. Higher scores represent more severe symptoms. The range of scores is 0 to 36. Scores are the sum of 12 item asking how often items have bothered someone in the past 2 weeks. Each item is measured on a scale of 0 to 3, where 0=not at all happens and 3=nearly every day.
Time frame: 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. The range of scores is 0 to 112. Scores are the sum of 28 items asking about how often they have experienced each item past month. Each item is measured on a scale of 0 to 4, where 0=almost never (less than once a month) and 4=always (several times a day).
Time frame: Baseline, End of 8-session Treatment (assessed up to 18 weeks)
TF-CBT Knowledge Score
Test of the level of knowledge of the lay counselors about TF-CBT, as assessed by the TF-CBT Knowledge Assessment. Higher scores represent greater group leader knowledge of TF-CBT. Scores could range from 0 to 32.5. The knowledge test was administered to all lay counselors at the end of their TF-CBT training to confirm their readiness to deliver the intervention. For each sequence, training occurred just before implementation of the intervention.
Time frame: Immediately Post-Training (on final day of training for the sequence, up to 6 days)
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Change in Prosocial Behavior (Child Report)
Change in behavioral strengths of the child, as assessed by the Prosocial Behavior subscale of the Strengths and Difficulties Questionnaire before and after the intervention. There are 5 items asking about the degree to which the child reports prosocial behavior. Each item has 3 possible responses on a scale of 0 to 2, where 0=not at all true and 2=certainly true. The total score summing across the 5 items could range from 0 to 10. Higher scores are more favorable, representing more prosocial behavior.
Time frame: Baseline, End of 8-session Treatment (assessed up to 18 weeks)
Change in Behavioral Problems (Guardian Report)
Change in behavioral problems of the child, as assessed by the Conduct Problems subscale of the Strengths and Difficulties Questionnaire, including additional items validated locally. There are 9 items asking about the degree to which the guardian reports conduct problems observed in the child. Each item has 3 possible responses on a scale of 0 to 2, where 0=not at all true and 2=certainly true. The total score summing across the 5 items could range from 0 to 18. Lower scores are more favorable, representing decreased behavioral problems.
Time frame: Baseline, 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.
Time frame: Baseline
Change in Proportion of Children Engaged in Excessive Child Labor for Pay
Change in proportion of children engaged in excessive child labor for pay in the past week, as assessed by the Child Work and Labor Questionnaire and reported by the child. 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. This is constructed as a binary variable, and we present a difference in the proportion of children who worked 14 or more hours in the past week for income-generating activities (work without pay was not assessed). Lower proportion is more favorable, representing fewer children engaged in excessive child labor for pay.
Time frame: Baseline to third annual follow-up
Change in Proportion of Children Engages in Excessive Household Assistance Without Pay
Change in proportion of children engaged in chores (non-income generating work around the home) in the past week, as reported by the child. This is constructed as a binary variable, and we present a difference in the proportion of children who did chores for 14 or more hours in the past week. Lower proportion is more favorable, representing fewer children engaged in excessive household assistance without pay.
Time frame: Baseline to third annual follow-up
Safer Sex Peer Norms Score
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. This measure is only administered if the child is 16 or older, so for this outcome, we report specifically on the Safer Sex Peer Norms assessment collected at the 3rd annual follow-up timepoint. Scores are the sum of 7-item asking about agreement with the item. Each item is measured on a scale of 1 to 4, where 1=strongly disagree and 4=strongly agree. The range of total scores is 0 to 28. Higher scores are more favorable, representing stronger agreement with positive peer norms.
Time frame: Third annual follow-up
Change in Proportion of Children Reporting Any Current Substance Use
Change in proportion of children reporting any current alcohol, tobacco, or other drug use, as assessed by the Safer Sex Peer Norms and Substance Use Questionnaire and reported by the child. This is reported as a binary variable representing the proportion of children who report current drug use or drinking alcohol in the past 7 days or using tobacco in the past 7 days. Lower proportion is more favorable.
Time frame: Baseline to third annual follow-up