Clinical trial NCT03243396: Building and Sustaining Interventions for Children: Task-sharing Mental Health Care in Low-resource Settings
Official title: Building and Sustaining Interventions for Children (BASIC): Task-sharing Mental Health Care in Low-resource Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Grief
Post Traumatic Stress Disorder
Depression
Keywords: 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
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Johns Hopkins University
name: Ace Africa
name: National Institute of Mental Health (NIMH)
First posted: 2017-08-09
Enrollment: 956
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Posttraumatic Stress Symptoms (Child Report)
timeFrame: Baseline, End of 8-session Treatment (assessed up to 18 weeks)
measure: Fidelity
timeFrame: End of first year of site implementation (2 groups, 8 sessions each)
measure: Number of Sites That Adopted the Intervention
timeFrame: End of first year of site implementation (2 groups, 8 sessions each)
measure: Number of Sites That Sustained the Intervention
timeFrame: Two years after the first TF-CBT groups for each site
Secondary outcomes:
measure: Change in Posttraumatic Stress Symptoms (Caregiver Report)
timeFrame: Baseline, End of 8-session Treatment (assessed up to 18 weeks)
measure: Change in Depressive Symptoms (Child Report)
timeFrame: Baseline, End of 8-session Treatment (assessed up to 18 weeks)
measure: Change in Grief (Child Report)
timeFrame: Baseline, End of 8-session Treatment (assessed up to 18 weeks)
measure: TF-CBT Knowledge Score
timeFrame: Immediately Post-Training (on final day of training for the sequence, up to 6 days)
measure: Change in Prosocial Behavior (Child Report)
timeFrame: Baseline, End of 8-session Treatment (assessed up to 18 weeks)
measure: Change in Behavioral Problems (Guardian Report)
timeFrame: Baseline, End of 8-session Treatment (assessed up to 18 weeks)
measure: School Attendance
timeFrame: Baseline
measure: Change in Proportion of Children Engaged in Excessive Child Labor for Pay
timeFrame: Baseline to third annual follow-up
measure: Change in Proportion of Children Engages in Excessive Household Assistance Without Pay
timeFrame: Baseline to third annual follow-up
measure: Safer Sex Peer Norms Score
timeFrame: Third annual follow-up
measure: Change in Proportion of Children Reporting Any Current Substance Use
timeFrame: Baseline to third annual follow-up
Other outcomes:
measure: Relationship Closeness
timeFrame: End of 8-session Treatment (assessed up to 18 weeks)
measure: Relationship Conflict
timeFrame: End of 8-session Treatment (assessed up to 18 weeks)
measure: Guardian-provided Social Support
timeFrame: End of 8-session Treatment (assessed up to 18 weeks)
measure: Intervention Acceptability
timeFrame: End of first year of site implementation (2 groups, 8 sessions each)
measure: Intervention Feasibility
timeFrame: End of first year of site implementation (2 groups, 8 sessions each)
measure: Intervention Appropriateness
timeFrame: End of first year of site implementation (2 groups, 8 sessions each)
Locations:
city: Bungoma
country: Kenya
facility: ACE Africa
state: Bungoma County
Study officials:
affiliation: Center for Health Policy and Inequalities Research at Duke University
name: Kathryn Whetten, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington Department of Psychology
name: Shannon Dorsey, PhD
role: PRINCIPAL_INVESTIGATOR
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