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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Duke University
Sponsor:
Collaborators:
Tanzania Women Research Foundation (TAWREF)
Action in the Community Environment (ACE) Africa
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01822366
First received: March 25, 2013
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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 Intervention
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

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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)


Estimated Enrollment: 640
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   7 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01822366

Contacts
Contact: Shannon Dorsey, PhD 206.543.4527 dorsey2@u.washington.edu

Locations
United States, Washington
University of Washington Department of Psychology Recruiting
Seattle, Washington, United States, 98195
Contact: Shannon Dorsey, PhD    206-543-4527    dorsey2@u.washington.edu   
Principal Investigator: Shannon Dorsey, PhD         
Kenya
Action in the Community Environment (ACE) Africa Recruiting
Bungoma, Kenya
Contact: Augustine Wasonga       augustine@ace-africa.org   
Tanzania
Tanzania Women Research Foundation (TAWREF) Recruiting
Moshi, Tanzania
Contact: Dafrosa Itemba       dafrosakoku@gmail.com   
Sponsors and Collaborators
Duke University
Tanzania Women Research Foundation (TAWREF)
Action in the Community Environment (ACE) Africa
Investigators
Principal Investigator: Shannon Dorsey, PhD University of Washington
Principal Investigator: Kate Whetten, PhD, MPH Duke University
  More Information

Additional Information:
No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01822366     History of Changes
Other Study ID Numbers: Pro00039770, R01MH096633
Study First Received: March 25, 2013
Last Updated: May 6, 2014
Health Authority: United States: Institutional Review Board
Kenya: Institutional Review Board
Tanzania: National Institute for Medical Research

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

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Depression
Anxiety Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 20, 2014