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. Identifier: NCT01822366
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : December 4, 2017
National Institute of Mental Health (NIMH)
Tanzania Women Research Foundation (TAWREF)
Action in the Community Environment (ACE) Africa
Information provided by (Responsible Party):
Duke University

Brief 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 (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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Posttraumatic Stress Disorder (PTS) [ Time Frame: 15 months ]
    Measured using the Child PTSD Symptoms Scale (CPSS) Caregiver and Child completed.

Secondary Outcome Measures :
  1. 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.

Other Outcome Measures:
  1. Childhood Traumatic Grief [ Time Frame: 15 months ]
    Measured using the Inventory of Complicated Grief.

  2. Depression [ Time Frame: 15 months ]
  3. Child Functioning [ Time Frame: 15 months ]
    Locally developed tool used to measure functional impairment and improvement over time.

  4. Child-Guardian Relationship [ Time Frame: 15 months ]
    Measured using the Child-Parent Relationship Scale (CPRS)

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Exclusion Criteria:

  • Living in an institution (not with a guardian).
  • Parent(s) died before child was 3 years old.

Information from the National Library of Medicine

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 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
Bungoma, Kenya
Tanzania Women Research Foundation (TAWREF)
Moshi, Tanzania
Sponsors and Collaborators
Duke University
National Institute of Mental Health (NIMH)
Tanzania Women Research Foundation (TAWREF)
Action in the Community Environment (ACE) Africa
Principal Investigator: Shannon Dorsey, PhD University of Washington
Principal Investigator: Kate Whetten, PhD, MPH Duke University

Responsible Party: Duke University Identifier: NCT01822366     History of Changes
Other Study ID Numbers: Pro00039770
R01MH096633 ( U.S. NIH Grant/Contract )
First Posted: April 2, 2013    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017

Keywords provided by Duke University:
Trauma-focused Cognitive Behavioral Therapy (TF-CBT)
Low- and Middle-Income Countries (LAMIC)
Randomized Controlled Trial (RCT)
Evidence-Based Practice (EBP)
Childhood Traumatic Grief (CTG)
Post-Traumatic Stress Disorder (PTSD)
East Africa
Mental Health

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Problem Behavior
Trauma and Stressor Related Disorders
Mental Disorders
Behavioral Symptoms