Randomized Controlled Trial of Trauma-focused CBT in Tanzania and Kenya
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 (10 rural, 10 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 (LAMICs). Findings will inform other efforts to scale up mental health interventions to address the substantial mental health gap.
Childhood Traumatic Grief
Post Traumatic Stress
Post Traumatic Stress Disorder
Child Overall Daily Functioning
Child and Guardian Relationship
Behavioral: Trauma-focused Cognitive Behavioral Therapy
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Improving Health Outcomes by Preventing HIV/STD Risk|
- Posttraumatic Stress Disorder (PTS) [ Time Frame: 15 months ] [ Designated as safety issue: No ]Measured using the Child PTSD Symptoms Scale (CPSS) Caregiver and Child completed.
- Behavioral Difficulties [ Time Frame: 15 months ] [ Designated as safety issue: No ]Measured using the Child Behavior Checklist (CBCL), Youth Self-Report (YSR), and items developed locally that are culturally specific.
- Childhood Traumatic Grief [ Time Frame: 15 months ] [ Designated as safety issue: No ]Measured using the Inventory of Complicated Grief.
- Depression [ Time Frame: 15 months ] [ Designated as safety issue: No ]
- Child Functioning [ Time Frame: 15 months ] [ Designated as safety issue: No ]Locally developed tool used to measure functional impairment and improvement over time.
- Child-Guardian Relationship [ Time Frame: 15 months ] [ Designated as safety issue: No ]Measured using the Child-Parent Relationship Scale (CPRS)
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
No Intervention: Usual Care Comparison Condition
Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.
Experimental: Trauma-focused CBT group therapy
Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
|Behavioral: Trauma-focused Cognitive Behavioral Therapy|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01822366
|Contact: Shannon Dorsey, PhDfirstname.lastname@example.org|
|United States, Washington|
|University of Washington Department of Psychology||Recruiting|
|Seattle, Washington, United States, 98195|
|Contact: Shannon Dorsey, PhD 206-543-4527 email@example.com|
|Principal Investigator: Shannon Dorsey, PhD|
|Action in the Community Environment (ACE) Africa||Recruiting|
|Contact: Augustine Wasonga firstname.lastname@example.org|
|Tanzania Women Research Foundation (TAWREF)||Recruiting|
|Contact: Dafrosa Itemba email@example.com|
|Principal Investigator:||Shannon Dorsey, PhD||University of Washington|
|Principal Investigator:||Kate Whetten, PhD, MPH||Duke University|