Randomized Controlled Trial of Trauma-focused CBT in Tanzania and Kenya
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01822366|
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : December 4, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Childhood Traumatic Grief Post Traumatic Stress Post Traumatic Stress Disorder Depressive Symptoms Behavioral Problems Child Overall Daily Functioning Child and Guardian Relationship||Behavioral: Trauma-focused Cognitive Behavioral Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||640 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Improving Health Outcomes by Preventing HIV/STD Risk|
|Actual Study Start Date :||August 2012|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
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|
- Posttraumatic Stress Disorder (PTS) [ Time Frame: 15 months ]Measured using the Child PTSD Symptoms Scale (CPSS) Caregiver and Child completed.
- Behavioral Difficulties [ Time Frame: 15 months ]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 ]Measured using the Inventory of Complicated Grief.
- Depression [ Time Frame: 15 months ]
- Child Functioning [ Time Frame: 15 months ]Locally developed tool used to measure functional impairment and improvement over time.
- Child-Guardian Relationship [ Time Frame: 15 months ]Measured using the Child-Parent Relationship Scale (CPRS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822366
|United States, Washington|
|University of Washington Department of Psychology|
|Seattle, Washington, United States, 98195|
|Action in the Community Environment (ACE) Africa|
|Tanzania Women Research Foundation (TAWREF)|
|Principal Investigator:||Shannon Dorsey, PhD||University of Washington|
|Principal Investigator:||Kate Whetten, PhD, MPH||Duke University|