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NCT01822366 · ClinicalTrials.gov registry record · NA
Randomized Controlled Trial of Trauma-focused CBT in Tanzania and Kenya
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 1,280
- Enrollment target
NCT01822366 is a NA study that has completed, run by Duke University. The registered enrollment target is 1,280 participants.
The verdict
NCT01822366, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,280 participants
- Enrollment target
Study 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 healt
Interventions
- BEHAVIORAL Trauma-focused Cognitive Behavioral Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,280 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01822366
The ClinicalTrials.gov registry entry for NCT01822366 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,280 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Trauma-focused Cognitive Behavioral Therapy is the first listed.
NCT01822366 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01822366 about?
NCT01822366 is a clinical study titled "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), throug...
What is the current status of trial NCT01822366?
This trial is currently completed. It is a NA study. The enrollment target is 1,280 participants. The study started on 2012-08. Estimated completion is 2016-11.
What interventions are being tested in trial NCT01822366?
The interventions under investigation include: Trauma-focused Cognitive Behavioral Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT01822366?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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