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

NCT01822366 | Completed Results DMC

• 2 other identifiers: Pro00039770R01MH096633
• Study Type: interventional
• Target: 1,280
• Locations: 3 countries
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (2)

• Posttraumatic Stress Syndrome (PTSS)

  Measured using the Child PTSD Symptoms Scale (CPSS). Caregiver and Child reported separately. Scale range 0-57, with 57 representing extremely high PTSS symptomatology (worse outcome). 634 children and 634 caregivers (1268 total) analyzed at baseline and 3-month follow-up--includes all 1280 enrolled at baseline, minus 12 lost to follow-up.

  Baseline, 3 months

• Childhood Traumatic Grief

  Measured using the Inventory of Complicated Grief (ICG). Child report only. Scale range 0-112, with 112 representing extremely high grief symptomatology (worse outcome). 634 children and 634 caregivers (1268 total) analyzed at baseline and 3-month follow-up--includes all 1280 enrolled at baseline, minus 12 lost to follow-up.

  Baseline, 3 months

Secondary Outcomes (1)

• Behavioral Difficulties

  Baseline, 3 months

Other Outcomes (3)

• Depression

  Baseline, 3 months

• Child Functioning

  Baseline, 3 months

• Child-Guardian Relationship

  Baseline, 3 months

Study Arms (2)

Usual Care Comparison Condition

NO INTERVENTION

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

Trauma-focused CBT group therapy

EXPERIMENTAL

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

Interventions

Trauma-focused Cognitive Behavioral Therapy BEHAVIORAL

Trauma-focused CBT group therapy

Eligibility Criteria

• Age: 7 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Mental Health (NIMH): collaborator
• Tanzania Women Research Foundation (TAWREF): collaborator
• Ace Africa: collaborator
• University of Washington: collaborator

Study Sites (3)

University of Washington Department of Psychology

Seattle, Washington, 98195, United States

Location

Action in the Community Environment (ACE) Africa

Bungoma, Kenya

Location

Tanzania Women Research Foundation (TAWREF)

Moshi, Tanzania

Location

Related Publications (1)

• 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.

  PMID: 31968059 DERIVED

Related Links

• Pamoja Tunaweza (Together We Can)

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Problem Behavior; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Child Behavior; Personal Satisfaction

Results Point of Contact

• Title: Dr. Shannon Dorsey
• Organization: University of Washington

dorsey2@uw.edu

(206) 543-4527

Study Officials

• Shannon Dorsey, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Kate Whetten, PhD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2013
• First Posted: April 2, 2013
• Study Start: August 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 5, 2021
• Results First Posted: May 23, 2019

Record last verified: 2021-04

Locations

TA (1); US (1); KE (1)