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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Care Comparison Condition

Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Trauma-focused Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

Interventions

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Trauma-focused Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Children ages 7-13 living in Moshi, Tanzania or Bungoma, Kenya who have had one or both parents die since they were 3 years old or older.
* Children must have scores on study measures indicating they have symptoms of traumatic grief and/or traumatic stress.
* Children must be living with an adult guardian who is willing to participate in 12 weekly group sessions.
* Adult guardians of eligible children.