Clinical trial NCT01822366: Randomized Controlled Trial of Trauma-focused CBT in Tanzania and Kenya
Official title: Improving Health Outcomes by Preventing HIV/STD Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Traumatic Grief
Post Traumatic Stress
Post Traumatic Stress Disorder
Depressive Symptoms
Behavioral Problems
Child Overall Daily Functioning
Child and Guardian Relationship
Keywords: Children
Adolescents
Trauma-focused Cognitive Behavioral Therapy (TF-CBT)
Low- and Middle-Income Countries (LMIC)
Randomized Controlled Trial (RCT)
Evidence-Based Practice (EBP)
Childhood Traumatic Grief (CTG)
Post-Traumatic Stress Disorder (PTSD)
Kenya
Tanzania
East Africa
Mental Health
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Tanzania Women Research Foundation (TAWREF)
name: Ace Africa
name: University of Washington
First posted: 2013-04-02
Enrollment: 1280
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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.


Eligibility 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.

Primary outcomes:
measure: Posttraumatic Stress Syndrome (PTSS)
timeFrame: Baseline, 3 months
measure: Childhood Traumatic Grief
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Behavioral Difficulties
timeFrame: Baseline, 3 months
Other outcomes:
measure: Depression
timeFrame: Baseline, 3 months
measure: Child Functioning
timeFrame: Baseline, 3 months
measure: Child-Guardian Relationship
timeFrame: Baseline, 3 months
Locations:
city: Seattle
country: United States
facility: University of Washington Department of Psychology
state: Washington
city: Bungoma
country: Kenya
facility: Action in the Community Environment (ACE) Africa
city: Moshi
country: Tanzania
facility: Tanzania Women Research Foundation (TAWREF)
Study officials:
affiliation: University of Washington
name: Shannon Dorsey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Kate Whetten, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dorsey S, Lucid L, Martin P, King KM, O'Donnell K, Murray LK, Wasonga AI, Itemba DK, Cohen JA, Manongi R, Whetten K. Effectiveness of Task-Shifted Trauma-Focused Cognitive Behavioral Therapy for Children Who Experienced Parental Death and Posttraumatic Stress in Kenya and Tanzania: A Randomized Clinical Trial. JAMA Psychiatry. 2020 May 1;77(5):464-473. doi: 10.1001/jamapsychiatry.2019.4475.