NCT01822366

Randomized Controlled Trial of Trauma-focused CBT in Tanzania and Kenya

Improving Health Outcomes by Preventing HIV/STD Risk

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,280 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 7 Years – 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Childhood Traumatic Grief
• Post Traumatic Stress
• Post Traumatic Stress Disorder
• Depressive Symptoms
• Behavioral Problems
• Child Overall Daily Functioning
• Child and Guardian Relationship

Interventions

Type	Name	Description
BEHAVIORAL	Trauma-focused Cognitive Behavioral Therapy

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2013-04-02
• Last updated: 2021-05-05
• Results posted: 2019-05-23

Locations

3 sites across 3 countries: United States, Kenya, Tanzania