This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Randomized Controlled Trial of Trauma-focused CBT in Tanzania and Kenya (NCT01822366), a randomized na study. The primary outcome is Posttraumatic Stress Syndrome (PTSS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01822366 |
| Phase | NA |
| Condition | Childhood Traumatic Grief, Post Traumatic Stress, Post Traumatic Stress Disorder |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 1280 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Duke University |
| Results posted | Yes |
2. Clinical Question
Population
The trial focused on orphaned children and young adolescents in Tanzania and Kenya. The registry describes participants across rural and urban settings in Moshi, Tanzania, and Bungoma, Kenya. The primary outcome description includes reports from both children and caregivers. The recorded conditions include traumatic grief, post-traumatic stress, depressive symptoms, behavioral problems, daily functioning, and the child–guardian relationship.
Intervention
The intervention was group-based Trauma-focused Cognitive Behavioral Therapy (TF-CBT). The arm description says that half of participating child–guardian dyads received a 12-week TF-CBT group treatment. The study summary describes a task-shifting approach in which lay counselors were trained to deliver the intervention with expert training and supervision.
Comparator
The comparison was usual care. The arm description says that half of participating child–guardian dyads received no intervention as the usual-care comparison condition. The study summary characterizes the comparison as usual care orphan services. The specific services received by participants in that condition are not reported in the registry record.
Primary question
The central question was whether the TF-CBT group intervention affected traumatic grief and traumatic stress compared with usual care. The listed primary outcome is posttraumatic stress syndrome (PTSS), measured using the Child PTSD Symptoms Scale (CPSS), with child and caregiver reports recorded separately. The stated assessment points are baseline and 3 months. The registry record does not report the means, confidence intervals, or a single treatment-effect estimate for these assessments, so the direction and magnitude of any difference cannot be described from the posted results.
3. Trial Design
This was a randomized, parallel-group trial with single masking. The registry lists an enrollment of 1280 and a completed status. The record identifies Duke University as sponsor. The study began in 2012-08, and primary completion was recorded as 2016-11. The phase is listed as not applicable.
The trial compared group-based Trauma-focused Cognitive Behavioral Therapy with a usual-care comparison condition. The arm descriptions state that half of participating child–guardian dyads were assigned to each condition. The intervention was described as a 12-week group treatment. The usual-care arm was described as receiving no intervention within the study, while the study summary refers to usual care orphan services. The specific content and intensity of usual care are not reported in the registry record.
The study was conducted in Moshi, Tanzania, and Bungoma, Kenya, with urban and rural settings represented. The summary describes collaboration with local organizations and investigators and a task-shifting model using lay counselors. It states that six counselors in each country would deliver 20 groups at each site, with 8 rural groups and 12 urban groups, resulting in 320 children and adolescents. The record does not establish which implementation details were achieved as planned, so these statements describe the study summary rather than verified delivery counts.
The primary outcome is listed as PTSS, assessed at baseline and 3 months, with separate child and caregiver reports. The registry also lists behavioral difficulties as a secondary outcome and identifies six outcome measures overall. The specific masking role, randomization sequence procedure, allocation concealment, and site-level allocation details are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Usual Care Comparison Condition - Children | Trauma-focused CBT Group Therapy - Children | Usual Care Comparison Condition - Caregivers | Trauma-focused CBT Group Therapy - Caregivers |
|---|---|---|---|---|
| STARTED | 320 | 320 | 320 | 320 |
| COMPLETED | 315 | 298 | 315 | 298 |
| NOT COMPLETED | 5 | 22 | 5 | 22 |
Reasons for not completing this period:
| Reason | Usual Care Comparison Condition - Children | Trauma-focused CBT Group Therapy - Children | Usual Care Comparison Condition - Caregivers | Trauma-focused CBT Group Therapy - Caregivers |
|---|---|---|---|---|
| Lost to Follow-up | 5 | 1 | 5 | 1 |
| Withdrawal by Subject | 0 | 6 | 0 | 6 |
| Partial Intervention Completion | 0 | 15 | 0 | 15 |
Analysis population for the primary outcome, as defined in the registry: Children and Caregivers from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban)
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Caregivers and Children were treated as dyads for the study, but have been categorized separately here for the purpose of reporting results.
| Characteristic | Unit | Usual Care Comparison Condition - Children | Trauma-focused CBT Group Therapy - Children | Usual Care Comparison Condition - Caregivers | Trauma-focused CBT Group Therapy - Caregivers | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 320 | 320 | 320 | 320 | 1280 | |
| Age, Categorical: <=18 years | Participants | 318 | 318 | 0 | 0 | 636 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 298 | 292 | 590 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 22 | 28 | 50 |
| Age, Continuous | years | 10.68 (SD 1.66) | 10.58 (SD 1.60) | 45.10 (SD 13.34) | 44.43 (SD 12.36) | 27.75 (SD 19.38) |
| Sex: Female, Male: Female | Participants | 160 | 160 | 288 | 286 | 894 |
| Sex: Female, Male: Male | Participants | 160 | 160 | 32 | 34 | 386 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 320 | 320 | 320 | 320 | 1280 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 320 | 320 | 320 | 320 | 1280 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment: Tanzania | participants | 160 | 160 | 160 | 160 | 640 |
| Region of Enrollment: Kenya | participants | 160 | 160 | 160 | 160 | 640 |
6. Primary Endpoint
The registry lists the primary outcome as Posttraumatic Stress Syndrome (PTSS), measured over Baseline, 3 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is posttraumatic stress syndrome (PTSS), measured with the Child PTSD Symptoms Scale (CPSS). The record describes a scale range of 0-57 and states that 57 represents extremely high PTSS symptomatology, or a worse outcome. This direction is important when interpreting any reported means: a higher score corresponds to more severe symptoms according to the registry description.
Reports from children and caregivers were collected separately. The stated time points are baseline and 3 months. Separate reporting can help distinguish the child’s account from the caregiver’s observations; these are different sources of information and should not be treated as interchangeable measurements. The record describes the primary outcome as a mean score with a 95% confidence interval.
PTSS is relevant to the trial’s stated aim because the intervention was intended to address traumatic stress and traumatic grief in orphaned children and young adolescents. The registry record also lists other areas of interest, including depressive symptoms, behavioral problems, daily functioning, and the child–guardian relationship. Those additional areas do not change the meaning of the specified primary endpoint. Actual CPSS means and confidence intervals at either assessment point are not reported in the registry record, so the observed PTSS levels and changes cannot be characterized.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison of TF-CBT and usual care, and describes PTSS as the primary outcome. It also specifies child and caregiver reports at baseline and 3 months. However, the posted results do not give the CPSS means or their 95% confidence intervals. They do not provide a between-group contrast, an estimate of change, or a test result. Consequently, the outcome’s direction, size, and statistical precision cannot be assessed from the registry record.
The record states that 634 children and 634 caregivers were analyzed at baseline and 3-month follow-up, 1268 total. It describes this as including all 1280 enrolled at baseline, minus 12 lost to follow-up. These counts describe the reported analysis population, but do not reveal the results within either randomized group. Nor do they show whether the analysis compared follow-up scores, changes from baseline, or another estimand. Those analysis details are not reported in the registry record.
A confidence interval conveys uncertainty around an estimate. In general, it indicates a range of values compatible with the data and the method used to construct the interval; it does not by itself establish whether a difference is important. Here, the registry gives the intended dispersion format but not the intervals themselves. There is therefore no basis for describing the precision of the treatment comparison or whether the data are compatible with a range of possible effects.
The record identifies several outcome categories and more than one assessment time, and the primary outcome is not reduced to one comparison. No analysis entries are listed. Without the statistical comparisons, prespecified analysis details, and outcome estimates, the trial’s posted record cannot establish whether the groups differed on PTSS or other outcomes. The reported enrollment and follow-up counts alone do not answer the effectiveness question.
9. Statistical Methods Explained
What does the listed mean represent?
PTSS is a continuous score on the CPSS. A mean summarizes the average score for a group, while individual participants may have scores above or below that average. The registry identifies the measure as a mean and gives its scale range as 0-57, with higher scores representing worse symptomatology. A group mean is useful for summarizing the overall level of reported symptoms, but it does not describe the full distribution of scores or the experiences of every child.
The registry says caregiver and child reports were collected separately. Those reports represent distinct perspectives. They should be interpreted as separate outcome measurements unless an analysis explicitly combines them. The listed outcome description does not say that they were combined, and the posted record does not provide a statistical model for handling the two sources.
How should a 95% confidence interval be read?
A confidence interval expresses statistical uncertainty around an estimated quantity. In general, a narrower interval indicates greater precision than a wider interval, given the same kind of estimate and method. An interval around a group mean describes uncertainty about that mean; an interval around a contrast describes uncertainty about the difference being estimated. These are not the same quantity. The registry lists 95% confidence intervals as the dispersion measure, but numerical intervals for the PTSS results are not reported in the registry record.
For a treatment comparison, the estimate and its interval need to be interpreted together. The estimate conveys the direction and size of the observed contrast, while its interval conveys uncertainty. A confidence interval is not a guarantee that the true value lies within its endpoints, nor does it establish clinical importance by itself. Because the posted results do not include an estimate or interval for a contrast between trial arms, neither the direction nor precision of that comparison can be described.
Why does the comparison definition matter?
Baseline and follow-up scores can be analyzed in different ways. An analysis might compare groups at follow-up, compare change over time, or use a model that accounts for baseline scores. These approaches can answer related but not identical questions. The record lists baseline and 3-month assessments, but does not report which comparison was used, whether baseline scores were adjusted for, or how repeated measurements were modeled. No specific analysis method should therefore be attributed to the trial.
Children and caregivers also contribute separate reports, and the record identifies several outcome areas. A clear analysis plan would specify which outcome and reporter define each comparison, which assessment time is primary, and how multiple outcomes are handled. Such a plan is not reported in the registry record. The record lists six outcome measures overall, but does not present analysis entries or a single PTSS comparison.
What can the planning assumptions tell us?
The record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect. These are assumptions for planning illustrations, not evidence of the trial’s achieved statistical power or a substitute for an observed treatment estimate. The planning values and the observed effect needed to interpret them are not reported in the registry record.
Sample-size planning asks how many participants would be needed under specified assumptions. It does not show that a trial’s result is statistically significant, clinically important, or precise. The record does not report a trial-specific sample-size justification, the effect assumed at design, or an account of interim analyses. Those details should not be inferred from the planning assumptions.
What is needed to interpret the posted results?
Interpretation would require the group-specific PTSS summaries, a clearly defined between-group estimate, its uncertainty, and the analysis population and method used. The registry record supplies enrollment and follow-up counts and identifies the endpoint, but it does not report those estimates or methods. In general, over-dispersion matters when outcome variability exceeds what an analysis model assumes; if present and unaccounted for, standard errors and confidence intervals may be misleading. The record does not provide enough information to assess whether over-dispersion is relevant to these scores or how variability was handled.
Likewise, the type of model, assumptions about missing observations, any adjustment for site or other factors, and the handling of repeated measurements are not reported in the registry record. These are not details that can be reconstructed from the endpoint description or enrollment count. The defensible statistical reading is therefore limited to the design and outcome definitions recorded, not an estimate of treatment effect.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists six outcome measures overall, identifies behavioral difficulties as a secondary outcome, and describes PTSS assessments at baseline and 3 months with both child and caregiver reports. This creates multiple possible outcome and time-point comparisons. The primary outcome entry is not reduced to one comparison, and no analysis entries are listed. The registry record does not report which comparisons were designated for confirmatory inference, whether any multiplicity adjustment was used, or how secondary outcomes were prioritized. Without that information, the chance of false-positive findings across multiple tests cannot be evaluated.
The record states that 634 children and 634 caregivers were analyzed at baseline and 3-month follow-up, 1268 total, and notes 12 lost to follow-up among 1280 enrolled. It does not describe the reasons for loss, the timing of missingness, or whether missing observations differed between arms. The method for handling missing outcome data, including any imputation or sensitivity analysis, is not reported in the registry record. The counts alone cannot show whether missingness could have influenced a comparison.
The analysis population is not defined beyond the stated analysis counts. The record does not say whether the analysis followed randomized assignment, included only participants with observed follow-up data, or used another population definition. It also does not report whether caregiver and child observations were analyzed in separate populations or how their availability was handled. These omissions limit assessment of potential bias and reproducibility.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Usual Care Comparison Condition | 0 | 640 | 0.0% |
| Trauma-focused CBT Group Therapy | 0 | 640 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Usual Care Comparison Condition | 0 of 640 |
| Trauma-focused CBT Group Therapy | 0 of 640 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Usual Care Comparison Condition | 0 of 640 |
| Trauma-focused CBT Group Therapy | 0 of 640 |
The registry lists 640 participants at risk in each arm for the serious adverse event entries and reports 0 serious adverse events in both the usual-care comparison condition and the TF-CBT group therapy arm. It also lists 640 at risk in each arm for other adverse events and reports 0 other adverse events in both arms. Deaths are recorded as 0 in each arm, and no serious adverse event terms are listed.
These figures describe events recorded in the registry. They do not by themselves establish that no adverse experiences occurred, since interpretation depends on what events were collected, how they were defined, the observation period, and completeness of reporting. The registry record does not provide further details about event monitoring, ascertainment procedures, or exposure time. The zero counts should therefore be read as no events reported in these entries, not as proof that risks were absent.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, parallel-group trial compared a 12-week group TF-CBT intervention with usual care for orphaned children and young adolescents in Tanzania and Kenya. It identifies PTSS measured with the CPSS as the primary outcome, with separate child and caregiver reports at baseline and 3 months. It also reports an analysis population of 634 children and 634 caregivers, 1268 total, and 12 lost to follow-up from 1280 enrolled.
Those design and follow-up details do not establish the intervention’s effect. The registry does not report outcome means, confidence intervals, a treatment contrast, or a statistical test. It is therefore not possible to determine from the posted results whether PTSS scores differed between groups, how large any difference was, or how precise an estimate might be. No conclusion about benefit or lack of benefit can be drawn from the enrollment and follow-up counts alone.
The record also does not provide enough information to judge whether any observed difference, if reported elsewhere, would be clinically important. That assessment would require the outcome estimates and context for interpreting changes in CPSS scores. The scale description gives the score range and direction but no threshold for meaningful change.
More broadly, the registry record does not document the analysis method, handling of missing data, multiplicity approach, or details of usual care. These omissions constrain assessment of the reliability and scope of any treatment comparison. The appropriate interpretation is limited to what the record documents: the trial’s stated question, design, endpoint, and reported participant counts, without a posted numerical efficacy result.
13. Why This Trial Matters Statistically
Statistically, this trial brings together a randomized comparison, a continuous symptom measure, reports from children and caregivers, and assessments at baseline and follow-up. Each feature affects how results should be summarized and interpreted. The estimate should identify the population, reporter, time point, and comparison it represents; otherwise, readers may confuse a group mean with a treatment effect or combine distinct sources of information.
The setting is also part of the statistical context. The trial summary describes work in Tanzania and Kenya and in rural and urban settings, with lay counselors delivering group treatment under a task-shifting approach. Such variation can matter when assessing whether results are consistent across settings or implementation contexts. The registry record does not report site-specific estimates or analyses of differences by setting, so those questions cannot be answered from the posted results.
Follow-up accounting is essential to interpreting a randomized study. The registry records 1280 enrolled, with 634 children and 634 caregivers analyzed at baseline and 3-month follow-up, 1268 total, and notes 12 lost to follow-up. Those counts help describe data availability, but they do not explain missingness or its potential impact. A transparent analysis would connect participant flow to the outcome estimates and the population used for inference.
The record’s lack of endpoint estimates is particularly important: a completed status and an identified primary outcome do not reveal the result. A careful statistical reading distinguishes trial design from evidence about an effect. Here, the design and measurement framework are documented, but the posted numerical comparison and its uncertainty are not reported in the registry record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpreting this trial record is that it does not report numerical PTSS results. Although the endpoint, scale, reporters, time points, and analysis counts are described, group means, 95% confidence intervals, and a between-group estimate are not reported in the registry record. The effectiveness question therefore cannot be answered from the posted results.
The statistical analysis is also insufficiently documented for independent appraisal. No analysis entries are listed, and the record does not report the model, comparison estimand, handling of baseline scores, or treatment of repeated observations. It does not describe multiplicity procedures despite multiple outcomes, reporters, and assessment times. Missing-data methods, reasons for loss to follow-up, and the analysis population definition are not reported in the registry record.
The record describes a single-masked design but does not specify who was masked or how masking was maintained. Procedures for random sequence generation and allocation concealment are not reported. The content of usual care is not detailed, making it difficult to characterize the contrast beyond the arm descriptions. The registry also does not report outcome estimates by country, rural or urban setting, or other subgroups.
Finally, the summary describes a task-shifting delivery model and planned group structure, but the record does not provide detailed implementation or adherence results. These limitations concern the information documented in the registry record; they do not establish that the trial itself lacked such procedures or analyses.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Randomized Controlled Trial of Trauma-focused CBT in Tanzania and Kenya — NCT01822366.
- Registry record last updated 2021-05-05; status last verified 2021-04.
- Results first posted 2019-05-23.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed randomized, single-masked, parallel-group trial of group-based TF-CBT versus usual care for orphaned children and young adolescents in Tanzania and Kenya. Enrollment was 1280. The primary outcome was PTSS measured with the CPSS, with separate child and caregiver reports at baseline and 3 months. The record states that 634 children and 634 caregivers were analyzed, 1268 total, and notes 12 lost to follow-up.
Numerical primary outcome results and a treatment-effect estimate are not reported in the registry record. The record lists 0 serious adverse events, 0 other adverse events, and 0 deaths in each arm. Details of the analysis method, missing-data handling, and multiplicity procedures are not reported.