Trial Outcomes & Findings for Randomized Controlled Trial of Trauma-focused CBT in Tanzania and Kenya (NCT NCT01822366)
NCT ID: NCT01822366
Last Updated: 2021-05-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1280 participants
Primary outcome timeframe
Baseline, 3 months
Results posted on
2021-05-05
Participant Flow
Participant milestones
| Measure |
Usual Care Comparison Condition - Children
Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.
|
Trauma-focused CBT Group Therapy - Children
Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Usual Care Comparison Condition - Caregivers
Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.
|
Trauma-focused CBT Group Therapy - Caregivers
Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
320
|
320
|
320
|
320
|
|
Overall Study
COMPLETED
|
315
|
298
|
315
|
298
|
|
Overall Study
NOT COMPLETED
|
5
|
22
|
5
|
22
|
Reasons for withdrawal
| Measure |
Usual Care Comparison Condition - Children
Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.
|
Trauma-focused CBT Group Therapy - Children
Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Usual Care Comparison Condition - Caregivers
Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.
|
Trauma-focused CBT Group Therapy - Caregivers
Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
6
|
0
|
6
|
|
Overall Study
Partial Intervention Completion
|
0
|
15
|
0
|
15
|
Baseline Characteristics
Child age missing for 2 comparison and 2 intervention participants.
Baseline characteristics by cohort
| Measure |
Usual Care Comparison Condition - Children
n=320 Participants
Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.
|
Trauma-focused CBT Group Therapy - Children
n=320 Participants
Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Usual Care Comparison Condition - Caregivers
n=320 Participants
Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.
|
Trauma-focused CBT Group Therapy - Caregivers
n=320 Participants
Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Total
n=1280 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
318 Participants
n=318 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
318 Participants
n=318 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
0 Participants
n=320 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
0 Participants
n=320 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
636 Participants
n=1276 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=318 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
0 Participants
n=318 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
298 Participants
n=320 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
292 Participants
n=320 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
590 Participants
n=1276 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=318 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
0 Participants
n=318 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
22 Participants
n=320 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
28 Participants
n=320 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
50 Participants
n=1276 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
|
Age, Continuous
|
10.68 years
STANDARD_DEVIATION 1.66 • n=318 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
10.58 years
STANDARD_DEVIATION 1.60 • n=318 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
45.10 years
STANDARD_DEVIATION 13.34 • n=320 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
44.43 years
STANDARD_DEVIATION 12.36 • n=320 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
27.75 years
STANDARD_DEVIATION 19.38 • n=1276 Participants • Child age missing for 2 comparison and 2 intervention participants.
|
|
Sex: Female, Male
Female
|
160 Participants
n=320 Participants
|
160 Participants
n=320 Participants
|
288 Participants
n=320 Participants
|
286 Participants
n=320 Participants
|
894 Participants
n=1280 Participants
|
|
Sex: Female, Male
Male
|
160 Participants
n=320 Participants
|
160 Participants
n=320 Participants
|
32 Participants
n=320 Participants
|
34 Participants
n=320 Participants
|
386 Participants
n=1280 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=1280 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
320 Participants
n=320 Participants
|
320 Participants
n=320 Participants
|
320 Participants
n=320 Participants
|
320 Participants
n=320 Participants
|
1280 Participants
n=1280 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=1280 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=1280 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=1280 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=1280 Participants
|
|
Race (NIH/OMB)
Black or African American
|
320 Participants
n=320 Participants
|
320 Participants
n=320 Participants
|
320 Participants
n=320 Participants
|
320 Participants
n=320 Participants
|
1280 Participants
n=1280 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=1280 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=1280 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=320 Participants
|
0 Participants
n=1280 Participants
|
|
Region of Enrollment
Tanzania
|
160 participants
n=320 Participants
|
160 participants
n=320 Participants
|
160 participants
n=320 Participants
|
160 participants
n=320 Participants
|
640 participants
n=1280 Participants
|
|
Region of Enrollment
Kenya
|
160 participants
n=320 Participants
|
160 participants
n=320 Participants
|
160 participants
n=320 Participants
|
160 participants
n=320 Participants
|
640 participants
n=1280 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsPopulation: Children and Caregivers from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban)
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.
Outcome measures
| Measure |
Tanzania Rural Comparison Child
n=64 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Tanzania Urban Comparison Child
n=91 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Tanzania Rural TF-CBT Child
n=63 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Tanzania Urban TF-CBT Child
n=96 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Kenya Rural Comparison Child
n=64 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Kenya Urban Comparison Child
n=96 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Kenya Rural TF-CBT Child
n=64 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Kenya Urban TF-CBT Child
n=96 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Tanzania Rural Comparison Caregiver
n=64 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Tanzania Urban Comparison Caregiver
n=91 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Tanzania Rural TF-CBT Caregiver
n=63 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Tanzania Urban TF-CBT Caregiver
n=96 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Kenya Rural Comparison Caregiver
n=64 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Kenya Urban Comparison Caregiver
n=96 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Kenya Rural TF-CBT Caregiver
n=64 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Kenya Urban TF-CBT Caregiver
n=96 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Posttraumatic Stress Syndrome (PTSS)
Mean Change in Score
|
-14.40 score on a scale
Interval -16.55 to -12.24
|
-8.39 score on a scale
Interval -10.19 to -6.6
|
-15.48 score on a scale
Interval -17.43 to -13.54
|
-12.53 score on a scale
Interval -14.17 to -10.88
|
-2.17 score on a scale
Interval -5.14 to 0.8
|
-6.11 score on a scale
Interval -7.76 to -4.47
|
-10.86 score on a scale
Interval -13.4 to -8.32
|
-11.88 score on a scale
Interval -13.41 to -10.34
|
-11.81 score on a scale
Interval -13.63 to -9.98
|
-8.77 score on a scale
Interval -10.56 to -6.98
|
-15.77 score on a scale
Interval -17.78 to -13.75
|
-14.23 score on a scale
Interval -16.07 to -12.39
|
-0.33 score on a scale
Interval -3.24 to 2.58
|
-5.91 score on a scale
Interval -7.78 to -4.03
|
-12.92 score on a scale
Interval -15.19 to -10.65
|
-12.04 score on a scale
Interval -13.48 to -10.61
|
|
Posttraumatic Stress Syndrome (PTSS)
Baseline Score
|
23.41 score on a scale
Interval 21.61 to 25.21
|
21.23 score on a scale
Interval 20.02 to 22.44
|
25.66 score on a scale
Interval 23.99 to 27.32
|
23.40 score on a scale
Interval 22.25 to 24.54
|
24.61 score on a scale
Interval 22.74 to 26.47
|
22.03 score on a scale
Interval 20.63 to 23.43
|
24.86 score on a scale
Interval 22.91 to 26.81
|
24.70 score on a scale
Interval 23.43 to 25.96
|
18.92 score on a scale
Interval 17.13 to 20.72
|
18.81 score on a scale
Interval 17.16 to 20.46
|
21.33 score on a scale
Interval 19.35 to 23.31
|
22.08 score on a scale
Interval 20.59 to 23.58
|
23.39 score on a scale
Interval 21.11 to 25.67
|
20.61 score on a scale
Interval 19.08 to 22.15
|
23.69 score on a scale
Interval 22.07 to 25.3
|
21.98 score on a scale
Interval 20.72 to 23.24
|
|
Posttraumatic Stress Syndrome (PTSS)
Post-Treatment Score
|
8.98 score on a scale
Interval 7.4 to 10.57
|
12.78 score on a scale
Interval 11.17 to 14.39
|
10.17 score on a scale
Interval 8.26 to 12.08
|
10.82 score on a scale
Interval 9.26 to 12.38
|
22.44 score on a scale
Interval 20.06 to 24.81
|
15.92 score on a scale
Interval 14.57 to 17.26
|
14.00 score on a scale
Interval 12.59 to 15.41
|
12.82 score on a scale
Interval 11.52 to 14.12
|
6.94 score on a scale
Interval 5.77 to 8.1
|
9.75 score on a scale
Interval 8.43 to 11.07
|
5.56 score on a scale
Interval 4.83 to 6.3
|
7.80 score on a scale
Interval 6.69 to 8.91
|
23.06 score on a scale
Interval 21.08 to 25.04
|
14.71 score on a scale
Interval 13.29 to 16.13
|
10.77 score on a scale
Interval 9.2 to 12.33
|
9.94 score on a scale
Interval 8.9 to 10.97
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsPopulation: Children from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban)
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.
Outcome measures
| Measure |
Tanzania Rural Comparison Child
n=64 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Tanzania Urban Comparison Child
n=91 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Tanzania Rural TF-CBT Child
n=63 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Tanzania Urban TF-CBT Child
n=96 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Kenya Rural Comparison Child
n=64 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Kenya Urban Comparison Child
n=96 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Kenya Rural TF-CBT Child
n=64 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Kenya Urban TF-CBT Child
n=96 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Tanzania Rural Comparison Caregiver
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Tanzania Urban Comparison Caregiver
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Tanzania Rural TF-CBT Caregiver
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Tanzania Urban TF-CBT Caregiver
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Kenya Rural Comparison Caregiver
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Kenya Urban Comparison Caregiver
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Kenya Rural TF-CBT Caregiver
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Kenya Urban TF-CBT Caregiver
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Childhood Traumatic Grief
Baseline Score
|
43.14 Score on a scale
Interval 38.18 to 48.1
|
40.63 Score on a scale
Interval 37.65 to 43.61
|
49.17 Score on a scale
Interval 43.98 to 54.37
|
44.73 Score on a scale
Interval 41.19 to 48.26
|
42.48 Score on a scale
Interval 37.7 to 47.27
|
38.34 Score on a scale
Interval 35.11 to 41.58
|
44.38 Score on a scale
Interval 38.98 to 49.77
|
42.46 Score on a scale
Interval 39.09 to 45.83
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Childhood Traumatic Grief
Post-Treatment Score
|
13.44 Score on a scale
Interval 9.93 to 16.96
|
22.90 Score on a scale
Interval 19.09 to 26.72
|
16.00 Score on a scale
Interval 11.07 to 20.93
|
18.97 Score on a scale
Interval 15.75 to 22.18
|
38.13 Score on a scale
Interval 32.74 to 43.51
|
25.19 Score on a scale
Interval 22.13 to 28.25
|
21.09 Score on a scale
Interval 18.17 to 24.01
|
20.32 Score on a scale
Interval 17.25 to 23.39
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Childhood Traumatic Grief
Mean Change in Score
|
-29.65 Score on a scale
Interval -35.42 to -23.88
|
-17.25 Score on a scale
Interval -20.97 to -13.54
|
-33.17 Score on a scale
Interval -38.2 to -28.15
|
-25.77 Score on a scale
Interval -29.98 to -21.55
|
-4.36 Score on a scale
Interval -11.12 to 2.4
|
-13.01 Score on a scale
Interval -17.15 to -8.88
|
-23.28 Score on a scale
Interval -29.76 to -16.8
|
-22.14 Score on a scale
Interval -26.06 to -18.21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Children and Caregivers from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban)
Child report: Measured using the combined mean score of 1) the broadband externalizing scale of the Youth Self-Report (YSR) and 2) behavior-related items developed locally that are culturally specific. All items included are measured on a scale of 0-2, with 0 representing no behavioral difficulties (better) and 2 representing frequent behavioral difficulties (worse). Caregiver report: Measured using the combined mean score of 1) the broadband externalizing scale of the Child Behavior Checklist (CBCL) and 2) behavior-related items developed locally that are culturally specific. All items included are measured on a scale of 0-2, with 0 representing no behavioral difficulties (better) and 2 representing frequent behavioral difficulties (worse).
Outcome measures
| Measure |
Tanzania Rural Comparison Child
n=64 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Tanzania Urban Comparison Child
n=91 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Tanzania Rural TF-CBT Child
n=63 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Tanzania Urban TF-CBT Child
n=96 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Kenya Rural Comparison Child
n=64 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Kenya Urban Comparison Child
n=96 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Kenya Rural TF-CBT Child
n=64 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Kenya Urban TF-CBT Child
n=96 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Tanzania Rural Comparison Caregiver
n=64 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Tanzania Urban Comparison Caregiver
n=91 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Tanzania Rural TF-CBT Caregiver
n=63 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Tanzania Urban TF-CBT Caregiver
n=96 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Kenya Rural Comparison Caregiver
n=64 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Kenya Urban Comparison Caregiver
n=96 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Kenya Rural TF-CBT Caregiver
n=64 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Kenya Urban TF-CBT Caregiver
n=96 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Behavioral Difficulties
Post-Treatment Score
|
0.06 Score on a scale
Interval 0.05 to 0.07
|
0.09 Score on a scale
Interval 0.07 to 0.1
|
0.08 Score on a scale
Interval 0.06 to 0.09
|
0.06 Score on a scale
Interval 0.05 to 0.08
|
0.13 Score on a scale
Interval 0.1 to 0.16
|
0.09 Score on a scale
Interval 0.07 to 0.12
|
0.11 Score on a scale
Interval 0.06 to 0.16
|
0.14 Score on a scale
Interval 0.1 to 0.18
|
0.12 Score on a scale
Interval 0.09 to 0.15
|
0.10 Score on a scale
Interval 0.08 to 0.12
|
0.09 Score on a scale
Interval 0.07 to 0.1
|
0.09 Score on a scale
Interval 0.07 to 0.1
|
0.16 Score on a scale
Interval 0.12 to 0.21
|
0.13 Score on a scale
Interval 0.11 to 0.16
|
0.11 Score on a scale
Interval 0.08 to 0.15
|
0.14 Score on a scale
Interval 0.12 to 0.17
|
|
Behavioral Difficulties
Mean Change in Score
|
-0.01 Score on a scale
Interval -0.03 to 0.01
|
-0.02 Score on a scale
Interval -0.04 to 0.0
|
-0.03 Score on a scale
Interval -0.07 to 0.0
|
-0.05 Score on a scale
Interval -0.08 to -0.02
|
0.00 Score on a scale
Interval -0.04 to 0.05
|
-0.05 Score on a scale
Interval -0.09 to -0.02
|
-0.07 Score on a scale
Interval -0.12 to -0.01
|
-0.07 Score on a scale
Interval -0.13 to -0.01
|
-0.03 Score on a scale
Interval -0.06 to 0.01
|
-0.07 Score on a scale
Interval -0.09 to -0.04
|
-0.02 Score on a scale
Interval -0.06 to -0.01
|
-0.09 Score on a scale
Interval -0.12 to -0.05
|
0.03 Score on a scale
Interval -0.02 to 0.07
|
-0.05 Score on a scale
Interval -0.08 to -0.02
|
-0.02 Score on a scale
Interval -0.05 to 0.02
|
-0.11 Score on a scale
Interval -0.15 to -0.08
|
|
Behavioral Difficulties
Baseline Score
|
0.07 Score on a scale
Interval 0.05 to 0.09
|
0.11 Score on a scale
Interval 0.09 to 0.13
|
0.11 Score on a scale
Interval 0.08 to 0.14
|
0.11 Score on a scale
Interval 0.09 to 0.14
|
0.13 Score on a scale
Interval 0.09 to 0.16
|
0.15 Score on a scale
Interval 0.12 to 0.18
|
0.18 Score on a scale
Interval 0.13 to 0.23
|
0.21 Score on a scale
Interval 0.17 to 0.26
|
0.15 Score on a scale
Interval 0.12 to 0.17
|
0.16 Score on a scale
Interval 0.14 to 0.19
|
0.12 Score on a scale
Interval 0.1 to 0.15
|
0.17 Score on a scale
Interval 0.14 to 0.21
|
0.14 Score on a scale
Interval 0.1 to 0.17
|
0.18 Score on a scale
Interval 0.15 to 0.21
|
0.13 Score on a scale
Interval 0.09 to 0.16
|
0.25 Score on a scale
Interval 0.21 to 0.29
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 monthsPopulation: Children and Caregivers from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban)
Child report: Measured using the combined mean score of 1) the broadband internalizing scale of the Youth Self-Report (YSR) and 2) depression-related items developed locally that are culturally specific. All items included are measured on a scale of 0-2, with 0 representing no depression (better) and 2 representing frequent signs of depression (worse). Caregiver report: Measured using the combined mean score of 1) the broadband internalizing scale of the Child Behavior Checklist (CBCL) and 2) depression-related items developed locally that are culturally specific. All items included are measured on a scale of 0-2, with 0 representing no depression (better) and 2 representing frequent signs of depression (worse).
Outcome measures
| Measure |
Tanzania Rural Comparison Child
n=64 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Tanzania Urban Comparison Child
n=91 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Tanzania Rural TF-CBT Child
n=63 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Tanzania Urban TF-CBT Child
n=96 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Kenya Rural Comparison Child
n=64 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Kenya Urban Comparison Child
n=96 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Kenya Rural TF-CBT Child
n=64 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Kenya Urban TF-CBT Child
n=96 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Tanzania Rural Comparison Caregiver
n=64 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Tanzania Urban Comparison Caregiver
n=91 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Tanzania Rural TF-CBT Caregiver
n=63 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Tanzania Urban TF-CBT Caregiver
n=96 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Kenya Rural Comparison Caregiver
n=64 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Kenya Urban Comparison Caregiver
n=96 Participants
Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.
|
Kenya Rural TF-CBT Caregiver
n=64 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
Kenya Urban TF-CBT Caregiver
n=96 Participants
Half of the participating child/caregiver dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment.
Trauma-focused Cognitive Behavioral Therapy
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Depression
Post-Treatment Score
|
0.18 Score on a scale
Interval 0.15 to 0.22
|
0.09 Score on a scale
Interval 0.07 to 0.1
|
0.21 Score on a scale
Interval 0.17 to 0.25
|
0.06 Score on a scale
Interval 0.05 to 0.08
|
0.53 Score on a scale
Interval 0.4 to 0.63
|
0.38 Score on a scale
Interval 0.31 to 0.45
|
0.30 Score on a scale
Interval 0.22 to 0.38
|
0.33 Score on a scale
Interval 0.27 to 0.39
|
0.17 Score on a scale
Interval 0.15 to 0.19
|
0.10 Score on a scale
Interval 0.08 to 0.12
|
0.15 Score on a scale
Interval 0.13 to 0.17
|
0.09 Score on a scale
Interval 0.07 to 0.1
|
0.55 Score on a scale
Interval 0.48 to 0.62
|
0.36 Score on a scale
Interval 0.3 to 0.41
|
0.28 Score on a scale
Interval 0.24 to 0.32
|
0.32 Score on a scale
Interval 0.28 to 0.36
|
|
Depression
Mean Change in Score
|
-0.05 Score on a scale
Interval -0.11 to 0.01
|
-0.02 Score on a scale
Interval -0.04 to 0.0
|
-0.21 Score on a scale
Interval -0.32 to -0.1
|
-0.05 Score on a scale
Interval -0.08 to -0.02
|
0.01 Score on a scale
Interval -0.16 to 0.18
|
-0.11 Score on a scale
Interval -0.2 to -0.03
|
-0.33 Score on a scale
Interval -0.48 to -0.19
|
-0.32 Score on a scale
Interval -0.43 to -0.22
|
-0.04 Score on a scale
Interval -0.08 to -0.01
|
-0.07 Score on a scale
Interval -0.09 to -0.04
|
-0.05 Score on a scale
Interval -0.09 to -0.02
|
-0.09 Score on a scale
Interval -0.12 to -0.05
|
0.07 Score on a scale
Interval -0.03 to 0.18
|
-0.12 Score on a scale
Interval -0.19 to -0.05
|
-0.20 Score on a scale
Interval -0.28 to -0.13
|
-0.26 Score on a scale
Interval -0.33 to -0.19
|
|
Depression
Baseline Score
|
0.23 Score on a scale
Interval 0.18 to 0.29
|
0.11 Score on a scale
Interval 0.09 to 0.13
|
0.41 Score on a scale
Interval 0.29 to 0.53
|
0.11 Score on a scale
Interval 0.09 to 0.14
|
0.52 Score on a scale
Interval 0.4 to 0.63
|
0.50 Score on a scale
Interval 0.43 to 0.57
|
0.63 Score on a scale
Interval 0.52 to 0.74
|
0.66 Score on a scale
Interval 0.57 to 0.74
|
0.21 Score on a scale
Interval 0.19 to 0.24
|
0.16 Score on a scale
Interval 0.14 to 0.19
|
0.20 Score on a scale
Interval 0.17 to 0.24
|
0.17 Score on a scale
Interval 0.14 to 0.21
|
0.48 Score on a scale
Interval 0.39 to 0.56
|
0.48 Score on a scale
Interval 0.42 to 0.54
|
0.48 Score on a scale
Interval 0.41 to 0.55
|
0.58 Score on a scale
Interval 0.52 to 0.64
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 monthsLocally developed tool used to measure functional impairment and improvement over time.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 3 monthsMeasured using the Child-Parent Relationship Scale (CPRS)
Outcome measures
Outcome data not reported
Adverse Events
Usual Care Comparison Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Trauma-focused CBT Group Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place