N/A
N=956
Building and Sustaining Interventions for Children: Task-sharing Mental Health Care in Low-resource Settings
Grief · Post Traumatic Stress Disorder · Depression
Bottom Line
View on ClinicalTrials.gov: NCT03243396 ↗Enrolled (actual)
956
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Change in Posttraumatic Stress Symptoms (Child Report) — -13.2; -12.8; -6.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trauma-Focused Cognitive Behavioral Therapy (Behavioral)
- Age
- Pediatric · 11+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Posttraumatic Stress Symptoms (Child Report) |
-13.2; -12.8; -6.9 | — |
| PRIMARY Fidelity |
4.1; 4.4 | — |
| PRIMARY Number of Sites That Adopted the Intervention |
40; 40 | — |
| PRIMARY Number of Sites That Sustained the Intervention |
16; 10 | — |
| SECONDARY Change in Posttraumatic Stress Symptoms (Caregiver Report) |
-17.1; -17.1; -8.4 | — |
| SECONDARY Change in Depressive Symptoms (Child Report) |
-3.6; -3.3; -2.3 | — |
| SECONDARY Change in Grief (Child Report) |
-23.0; -22.9; -10.8 | — |
| SECONDARY TF-CBT Knowledge Score |
25.1; 27.8 | — |
| SECONDARY Change in Prosocial Behavior (Child Report) |
0.09; 0.2; 0.2 | — |
| SECONDARY Change in Behavioral Problems (Guardian Report) |
-0.9; -0.7; -0.04 | — |
| SECONDARY School Attendance |
2.1; 1.9; 1.1 | — |
| SECONDARY Change in Proportion of Children Engaged in Excessive Child Labor for Pay |
0.1; 0.09; 0.12 | — |
| SECONDARY Change in Proportion of Children Engages in Excessive Household Assistance Without Pay |
0.3; 0.3; 0.2 | — |
| SECONDARY Safer Sex Peer Norms Score |
16.3; 16.7; 16.5 | — |
| SECONDARY Change in Proportion of Children Reporting Any Current Substance Use |
-0.01; -0.02; 0.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Child or young adolescent between the ages of 11 and 14 at the time of enrollment
- Child lost one or both parents to death at least 6 months ago or later, and when the child was 4 years old or older
- Child lives in the community with at least one adult guardian (18 years old or older)
- Child is experiencing borderline or clinically significant levels of post-traumatic stress or childhood traumatic grief (as indicated by a score of 18 or higher on the Child Posttraumatic Stress Scale, or a score of 35 or higher on the Inventory of Complicated Grief)
Exclusion Criteria
- Child has a known developmental or cognitive disability
- Child attends private school
- Child and family are about to move
- Children who lost a parent less than 6 months ago (since they may be experiencing a normal grief reaction and may not necessarily be in need of the treatment for CTG)
- Caregiver of the child refuses to participate
- Lay counselor is not literate
- Lay counselor does not have a mobile phone
- Lay counselor refuses to serve as a counselor
- Site leader refuses to allow their site to participate in the study
Data sourced from ClinicalTrials.gov (NCT03243396). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.