CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 956 enrolled
Drug / intervention
Trauma-Focused Cognitive Behavioral Therapybehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03243396
NCT03243396N/ACompleted

Building and Sustaining Interventions for Children (BASIC): Task-sharing Mental Health Care in Low-resource Settings

Duke University·interventional·Posted Aug 9, 2017·Updated Apr 1, 2025

In Brief

A clinical study evaluating Trauma-Focused Cognitive Behavioral Therapy for Grief and 2 related conditions. Completed, enrolled 956 participants across 1 site.

Detailed Summary

The BASIC study will take place in Kanduyi/Bungoma South Sub-County, in western Kenya, and focuses on children orphaned by one or two parents. Growing evidence demonstrates that orphaned children in low- and middle-income countries are at higher risk of mental health problems, but mental health professionals are largely unavailable in this area. Research suggests that some mental health treatments can be delivered effectively in low- and middle-income countries using a task-shifting approach, in which lay counselors with little or no prior mental health experience are trained to provide treatment, and deliver with supervision. However, very little is known about how to support local systems and organizations in delivering mental health care via task-shifting, particularly in a way that could scale-able and sustainable in the low-resource context. The BASIC team's prior work suggests that partnering with two government sectors, education and health, could be a low-cost and sustainable strategy to implement task-shifted mental health services. By training teachers (via the Education sector) and community health volunteers (via the Health sector) to provide mental health care, a larger population could potentially be reached. Before attempting any country or system-wide implementation, it is important to know what is needed to enable successful implementation in either or both sectors, client outcomes for those receiving mental health care when delivered via Education or Health, and cost of delivery in both sectors. The team aims to collect outcomes that are relevant to policy makers, and that can be considered along with cost and experiences in both sectors.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesKenya

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 9, 2017
Enrollment StartFeb 1, 2018
Primary CompletionJan 25, 2024
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 8.9 years ago

Interventions

Trauma-Focused Cognitive Behavioral Therapybehavioral

Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).