Randomized Controlled Trial of Trauma-focused CBT in Tanzania and Kenya
Condition: Childhood Traumatic Grief; Post Traumatic Stress; Post Traumatic Stress Disorder; Depressive Symptoms; Behavioral Problems; Child Overall Daily Functioning; Child and Guardian Relationship
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Depression; Problem Behavior
Study type: Interventional

Summary: 
      The primary goal is to study the effectiveness of Trauma-focused Cognitive Behavioral Therapy
      (TF-CBT) in treating traumatic grief and traumatic stress for orphaned children and young
      adolescents in two East African sites with high prevalence HIV, Moshi, Tanzania (TZ) and
      Bungoma, Kenya (KE), through a randomized controlled trial (RCT). In a previous feasibility
      study of TF-CBT with orphans in Tanzania, the investigators have found a group-based TF-CBT
      intervention to be feasible and acceptable, with promising clinical outcomes. In the
      feasibility study, lay counselors with no prior mental health experience delivered the
      intervention with training and supervision by our team of mental health and TF-CBT experts.

      Building on this initial study, the investigators are conducting a RCT to test the
      effectiveness of TF-CBT for traumatic grief and traumatic stress compared to receipt of usual
      care orphan services in TZ and KE. The study involves collaboration with HIV/AIDS grassroots
      organizations and local Co-Investigators in TZ and KE, both of whom are longstanding
      collaborators with the investigators' US team and are located in mixed urban and rural areas,
      allowing examination of effectiveness in two countries and two settings (urban/rural). Using
      a task-shifting approach, in which lay individuals are trained as counselors, the
      investigators will train six counselors in each country, who deliver 20 groups in each site
      (8 rural, 12 urban), resulting in 320 children and adolescents (ages 7-13) who receive TF-CBT
      and 320 who receive usual care. Outcomes for children are assessed at 12-14 weeks (i.e.,
      corresponding with the end of TF-CBT), 6-months post-treatment, and 12-months post-treatment.
      TF-CBT experts from the investigators' team partner with the lay counselors from the
      feasibility study (e.g., local trainers) to train the TZ and KE counselors, and these local
      trainers provide the TF-CBT supervision, while supervised themselves by the US-based TF-CBT
      and mental health experts. The investigators expect this trial to yield recommendations
      regarding an effective intervention for orphans that is acceptable, feasible, and includes
      local responsibility as a means to enhance potential sustainability in Low- and Middle-Income
      Countries (LMICs). Findings will inform other efforts to scale up mental health interventions
      to address the substantial mental health gap.
    


Intervention name(s): Trauma-focused Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Children; Adolescents; Trauma-focused Cognitive Behavioral Therapy (TF-CBT); Low- and Middle-Income Countries (LMIC); Randomized Controlled Trial (RCT); Evidence-Based Practice (EBP); Childhood Traumatic Grief (CTG); Post-Traumatic Stress Disorder (PTSD); Kenya; Tanzania; East Africa; Mental Health