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N/A N=956 Randomized Treatment

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

Grief · Post Traumatic Stress Disorder · Depression

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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