Childhood Traumatic Grief, Post Traumatic Stress, Post Traumatic Stress Disorder, Depressive Symptoms, Behavioral Problems, Child Overall Daily Functioning, Child and Guardian Relationship
Conditions
Keywords
Children, Adolescents, Trauma-focused Cognitive Behavioral Therapy (TF-CBT), Low- and Middle-Income Countries (LMIC), Randomized Controlled Trial (RCT), Evidence-Based Practice (EBP), Childhood Traumatic Grief (CTG), Post-Traumatic Stress Disorder (PTSD), Kenya, Tanzania, East Africa, Mental Health
Brief summary
The primary goal is to study the effectiveness of Trauma-focused Cognitive Behavioral Therapy (TF-CBT) in treating traumatic grief and traumatic stress for orphaned children and young adolescents in two East African sites with high prevalence HIV, Moshi, Tanzania (TZ) and Bungoma, Kenya (KE), through a randomized controlled trial (RCT). In a previous feasibility study of TF-CBT with orphans in Tanzania, the investigators have found a group-based TF-CBT intervention to be feasible and acceptable, with promising clinical outcomes. In the feasibility study, lay counselors with no prior mental health experience delivered the intervention with training and supervision by our team of mental health and TF-CBT experts. Building on this initial study, the investigators are conducting a RCT to test the effectiveness of TF-CBT for traumatic grief and traumatic stress compared to receipt of usual care orphan services in TZ and KE. The study involves collaboration with HIV/AIDS grassroots organizations and local Co-Investigators in TZ and KE, both of whom are longstanding collaborators with the investigators' US team and are located in mixed urban and rural areas, allowing examination of effectiveness in two countries and two settings (urban/rural). Using a task-shifting approach, in which lay individuals are trained as counselors, the investigators will train six counselors in each country, who deliver 20 groups in each site (8 rural, 12 urban), resulting in 320 children and adolescents (ages 7-13) who receive TF-CBT and 320 who receive usual care. Outcomes for children are assessed at 12-14 weeks (i.e., corresponding with the end of TF-CBT), 6-months post-treatment, and 12-months post-treatment. TF-CBT experts from the investigators' team partner with the lay counselors from the feasibility study (e.g., local trainers) to train the TZ and KE counselors, and these local trainers provide the TF-CBT supervision, while supervised themselves by the US-based TF-CBT and mental health experts. The investigators expect this trial to yield recommendations regarding an effective intervention for orphans that is acceptable, feasible, and includes local responsibility as a means to enhance potential sustainability in Low- and Middle-Income Countries (LMICs). Findings will inform other efforts to scale up mental health interventions to address the substantial mental health gap.
Interventions
Sponsors
National Institute of Mental Health (NIMH)
Tanzania Women Research Foundation (TAWREF)
Ace Africa
University of Washington
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
* Children ages 7-13 living in Moshi, Tanzania or Bungoma, Kenya who have had one or both parents die since they were 3 years old or older. * Children must have scores on study measures indicating they have symptoms of traumatic grief and/or traumatic stress. * Children must be living with an adult guardian who is willing to participate in 12 weekly group sessions. * Adult guardians of eligible children.
Exclusion criteria
* Living in an institution (not with a guardian). * Parent(s) died before child was 3 years old.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Posttraumatic Stress Syndrome (PTSS) | Baseline, 3 months | 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. |
| Childhood Traumatic Grief | Baseline, 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Behavioral Difficulties | Baseline, 3 months | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Depression | Baseline, 3 months | 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). |
| Child Functioning | Baseline, 3 months | Locally developed tool used to measure functional impairment and improvement over time. |
| Child-Guardian Relationship | Baseline, 3 months | Measured using the Child-Parent Relationship Scale (CPRS) |
Countries
Kenya, Tanzania, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Comparison Condition - Children Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control. | 320 |
| 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 | 320 |
| Usual Care Comparison Condition - Caregivers Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control. | 320 |
| 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 | 320 |
| Total | 1,280 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 1 | 5 | 1 |
| Overall Study | Partial Intervention Completion | 0 | 15 | 0 | 15 |
| Overall Study | Withdrawal by Subject | 0 | 6 | 0 | 6 |
Baseline characteristics
| Characteristic | Usual Care Comparison Condition - Children | Trauma-focused CBT Group Therapy - Children | Usual Care Comparison Condition - Caregivers | Trauma-focused CBT Group Therapy - Caregivers | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 318 Participants | 318 Participants | 0 Participants | 0 Participants | 636 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 22 Participants | 28 Participants | 50 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 298 Participants | 292 Participants | 590 Participants |
| Age, Continuous | 10.68 years STANDARD_DEVIATION 1.66 | 10.58 years STANDARD_DEVIATION 1.6 | 45.10 years STANDARD_DEVIATION 13.34 | 44.43 years STANDARD_DEVIATION 12.36 | 27.75 years STANDARD_DEVIATION 19.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 320 Participants | 320 Participants | 320 Participants | 320 Participants | 1280 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 320 Participants | 320 Participants | 320 Participants | 320 Participants | 1280 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Kenya | 160 participants | 160 participants | 160 participants | 160 participants | 640 participants |
| Region of Enrollment Tanzania | 160 participants | 160 participants | 160 participants | 160 participants | 640 participants |
| Sex: Female, Male Female | 160 Participants | 160 Participants | 288 Participants | 286 Participants | 894 Participants |
| Sex: Female, Male Male | 160 Participants | 160 Participants | 32 Participants | 34 Participants | 386 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 640 | 0 / 640 |
| other Total, other adverse events | 0 / 640 | 0 / 640 |
| serious Total, serious adverse events | 0 / 640 | 0 / 640 |
Outcome results
Primary
Childhood Traumatic Grief
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.
Time frame: Baseline, 3 months
Population: Children from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tanzania Rural Comparison Child | Childhood Traumatic Grief | Baseline Score | 43.14 Score on a scale |
| Tanzania Rural Comparison Child | Childhood Traumatic Grief | Post-Treatment Score | 13.44 Score on a scale |
| Tanzania Rural Comparison Child | Childhood Traumatic Grief | Mean Change in Score | -29.65 Score on a scale |
| Tanzania Urban Comparison Child | Childhood Traumatic Grief | Post-Treatment Score | 22.90 Score on a scale |
| Tanzania Urban Comparison Child | Childhood Traumatic Grief | Baseline Score | 40.63 Score on a scale |
| Tanzania Urban Comparison Child | Childhood Traumatic Grief | Mean Change in Score | -17.25 Score on a scale |
| Tanzania Rural TF-CBT Child | Childhood Traumatic Grief | Post-Treatment Score | 16.00 Score on a scale |
| Tanzania Rural TF-CBT Child | Childhood Traumatic Grief | Mean Change in Score | -33.17 Score on a scale |
| Tanzania Rural TF-CBT Child | Childhood Traumatic Grief | Baseline Score | 49.17 Score on a scale |
| Tanzania Urban TF-CBT Child | Childhood Traumatic Grief | Post-Treatment Score | 18.97 Score on a scale |
| Tanzania Urban TF-CBT Child | Childhood Traumatic Grief | Mean Change in Score | -25.77 Score on a scale |
| Tanzania Urban TF-CBT Child | Childhood Traumatic Grief | Baseline Score | 44.73 Score on a scale |
| Kenya Rural Comparison Child | Childhood Traumatic Grief | Post-Treatment Score | 38.13 Score on a scale |
| Kenya Rural Comparison Child | Childhood Traumatic Grief | Mean Change in Score | -4.36 Score on a scale |
| Kenya Rural Comparison Child | Childhood Traumatic Grief | Baseline Score | 42.48 Score on a scale |
| Kenya Urban Comparison Child | Childhood Traumatic Grief | Baseline Score | 38.34 Score on a scale |
| Kenya Urban Comparison Child | Childhood Traumatic Grief | Mean Change in Score | -13.01 Score on a scale |
| Kenya Urban Comparison Child | Childhood Traumatic Grief | Post-Treatment Score | 25.19 Score on a scale |
| Kenya Rural TF-CBT Child | Childhood Traumatic Grief | Post-Treatment Score | 21.09 Score on a scale |
| Kenya Rural TF-CBT Child | Childhood Traumatic Grief | Mean Change in Score | -23.28 Score on a scale |
| Kenya Rural TF-CBT Child | Childhood Traumatic Grief | Baseline Score | 44.38 Score on a scale |
| Kenya Urban TF-CBT Child | Childhood Traumatic Grief | Post-Treatment Score | 20.32 Score on a scale |
| Kenya Urban TF-CBT Child | Childhood Traumatic Grief | Mean Change in Score | -22.14 Score on a scale |
| Kenya Urban TF-CBT Child | Childhood Traumatic Grief | Baseline Score | 42.46 Score on a scale |
Primary
Posttraumatic Stress Syndrome (PTSS)
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.
Time frame: Baseline, 3 months
Population: Children and Caregivers from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tanzania Rural Comparison Child | Posttraumatic Stress Syndrome (PTSS) | Baseline Score | 23.41 score on a scale |
| Tanzania Rural Comparison Child | Posttraumatic Stress Syndrome (PTSS) | Mean Change in Score | -14.40 score on a scale |
| Tanzania Rural Comparison Child | Posttraumatic Stress Syndrome (PTSS) | Post-Treatment Score | 8.98 score on a scale |
| Tanzania Urban Comparison Child | Posttraumatic Stress Syndrome (PTSS) | Post-Treatment Score | 12.78 score on a scale |
| Tanzania Urban Comparison Child | Posttraumatic Stress Syndrome (PTSS) | Baseline Score | 21.23 score on a scale |
| Tanzania Urban Comparison Child | Posttraumatic Stress Syndrome (PTSS) | Mean Change in Score | -8.39 score on a scale |
| Tanzania Rural TF-CBT Child | Posttraumatic Stress Syndrome (PTSS) | Mean Change in Score | -15.48 score on a scale |
| Tanzania Rural TF-CBT Child | Posttraumatic Stress Syndrome (PTSS) | Baseline Score | 25.66 score on a scale |
| Tanzania Rural TF-CBT Child | Posttraumatic Stress Syndrome (PTSS) | Post-Treatment Score | 10.17 score on a scale |
| Tanzania Urban TF-CBT Child | Posttraumatic Stress Syndrome (PTSS) | Post-Treatment Score | 10.82 score on a scale |
| Tanzania Urban TF-CBT Child | Posttraumatic Stress Syndrome (PTSS) | Baseline Score | 23.40 score on a scale |
| Tanzania Urban TF-CBT Child | Posttraumatic Stress Syndrome (PTSS) | Mean Change in Score | -12.53 score on a scale |
| Kenya Rural Comparison Child | Posttraumatic Stress Syndrome (PTSS) | Mean Change in Score | -2.17 score on a scale |
| Kenya Rural Comparison Child | Posttraumatic Stress Syndrome (PTSS) | Baseline Score | 24.61 score on a scale |
| Kenya Rural Comparison Child | Posttraumatic Stress Syndrome (PTSS) | Post-Treatment Score | 22.44 score on a scale |
| Kenya Urban Comparison Child | Posttraumatic Stress Syndrome (PTSS) | Mean Change in Score | -6.11 score on a scale |
| Kenya Urban Comparison Child | Posttraumatic Stress Syndrome (PTSS) | Baseline Score | 22.03 score on a scale |
| Kenya Urban Comparison Child | Posttraumatic Stress Syndrome (PTSS) | Post-Treatment Score | 15.92 score on a scale |
| Kenya Rural TF-CBT Child | Posttraumatic Stress Syndrome (PTSS) | Baseline Score | 24.86 score on a scale |
| Kenya Rural TF-CBT Child | Posttraumatic Stress Syndrome (PTSS) | Post-Treatment Score | 14.00 score on a scale |
| Kenya Rural TF-CBT Child | Posttraumatic Stress Syndrome (PTSS) | Mean Change in Score | -10.86 score on a scale |
| Kenya Urban TF-CBT Child | Posttraumatic Stress Syndrome (PTSS) | Post-Treatment Score | 12.82 score on a scale |
| Kenya Urban TF-CBT Child | Posttraumatic Stress Syndrome (PTSS) | Mean Change in Score | -11.88 score on a scale |
| Kenya Urban TF-CBT Child | Posttraumatic Stress Syndrome (PTSS) | Baseline Score | 24.70 score on a scale |
| Tanzania Rural Comparison Caregiver | Posttraumatic Stress Syndrome (PTSS) | Post-Treatment Score | 6.94 score on a scale |
| Tanzania Rural Comparison Caregiver | Posttraumatic Stress Syndrome (PTSS) | Baseline Score | 18.92 score on a scale |
| Tanzania Rural Comparison Caregiver | Posttraumatic Stress Syndrome (PTSS) | Mean Change in Score | -11.81 score on a scale |
| Tanzania Urban Comparison Caregiver | Posttraumatic Stress Syndrome (PTSS) | Mean Change in Score | -8.77 score on a scale |
| Tanzania Urban Comparison Caregiver | Posttraumatic Stress Syndrome (PTSS) | Baseline Score | 18.81 score on a scale |
| Tanzania Urban Comparison Caregiver | Posttraumatic Stress Syndrome (PTSS) | Post-Treatment Score | 9.75 score on a scale |
| Tanzania Rural TF-CBT Caregiver | Posttraumatic Stress Syndrome (PTSS) | Baseline Score | 21.33 score on a scale |
| Tanzania Rural TF-CBT Caregiver | Posttraumatic Stress Syndrome (PTSS) | Post-Treatment Score | 5.56 score on a scale |
| Tanzania Rural TF-CBT Caregiver | Posttraumatic Stress Syndrome (PTSS) | Mean Change in Score | -15.77 score on a scale |
| Tanzania Urban TF-CBT Caregiver | Posttraumatic Stress Syndrome (PTSS) | Baseline Score | 22.08 score on a scale |
| Tanzania Urban TF-CBT Caregiver | Posttraumatic Stress Syndrome (PTSS) | Post-Treatment Score | 7.80 score on a scale |
| Tanzania Urban TF-CBT Caregiver | Posttraumatic Stress Syndrome (PTSS) | Mean Change in Score | -14.23 score on a scale |
| Kenya Rural Comparison Caregiver | Posttraumatic Stress Syndrome (PTSS) | Post-Treatment Score | 23.06 score on a scale |
| Kenya Rural Comparison Caregiver | Posttraumatic Stress Syndrome (PTSS) | Baseline Score | 23.39 score on a scale |
| Kenya Rural Comparison Caregiver | Posttraumatic Stress Syndrome (PTSS) | Mean Change in Score | -0.33 score on a scale |
| Kenya Urban Comparison Caregiver | Posttraumatic Stress Syndrome (PTSS) | Baseline Score | 20.61 score on a scale |
| Kenya Urban Comparison Caregiver | Posttraumatic Stress Syndrome (PTSS) | Post-Treatment Score | 14.71 score on a scale |
| Kenya Urban Comparison Caregiver | Posttraumatic Stress Syndrome (PTSS) | Mean Change in Score | -5.91 score on a scale |
| Kenya Rural TF-CBT Caregiver | Posttraumatic Stress Syndrome (PTSS) | Baseline Score | 23.69 score on a scale |
| Kenya Rural TF-CBT Caregiver | Posttraumatic Stress Syndrome (PTSS) | Mean Change in Score | -12.92 score on a scale |
| Kenya Rural TF-CBT Caregiver | Posttraumatic Stress Syndrome (PTSS) | Post-Treatment Score | 10.77 score on a scale |
| Kenya Urban TF-CBT Caregiver | Posttraumatic Stress Syndrome (PTSS) | Post-Treatment Score | 9.94 score on a scale |
| Kenya Urban TF-CBT Caregiver | Posttraumatic Stress Syndrome (PTSS) | Baseline Score | 21.98 score on a scale |
| Kenya Urban TF-CBT Caregiver | Posttraumatic Stress Syndrome (PTSS) | Mean Change in Score | -12.04 score on a scale |
Secondary
Behavioral Difficulties
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).
Time frame: Baseline, 3 months
Population: Children and Caregivers from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tanzania Rural Comparison Child | Behavioral Difficulties | Post-Treatment Score | 0.06 Score on a scale |
| Tanzania Rural Comparison Child | Behavioral Difficulties | Baseline Score | 0.07 Score on a scale |
| Tanzania Rural Comparison Child | Behavioral Difficulties | Mean Change in Score | -0.01 Score on a scale |
| Tanzania Urban Comparison Child | Behavioral Difficulties | Baseline Score | 0.11 Score on a scale |
| Tanzania Urban Comparison Child | Behavioral Difficulties | Post-Treatment Score | 0.09 Score on a scale |
| Tanzania Urban Comparison Child | Behavioral Difficulties | Mean Change in Score | -0.02 Score on a scale |
| Tanzania Rural TF-CBT Child | Behavioral Difficulties | Baseline Score | 0.11 Score on a scale |
| Tanzania Rural TF-CBT Child | Behavioral Difficulties | Mean Change in Score | -0.03 Score on a scale |
| Tanzania Rural TF-CBT Child | Behavioral Difficulties | Post-Treatment Score | 0.08 Score on a scale |
| Tanzania Urban TF-CBT Child | Behavioral Difficulties | Post-Treatment Score | 0.06 Score on a scale |
| Tanzania Urban TF-CBT Child | Behavioral Difficulties | Baseline Score | 0.11 Score on a scale |
| Tanzania Urban TF-CBT Child | Behavioral Difficulties | Mean Change in Score | -0.05 Score on a scale |
| Kenya Rural Comparison Child | Behavioral Difficulties | Post-Treatment Score | 0.13 Score on a scale |
| Kenya Rural Comparison Child | Behavioral Difficulties | Mean Change in Score | 0.00 Score on a scale |
| Kenya Rural Comparison Child | Behavioral Difficulties | Baseline Score | 0.13 Score on a scale |
| Kenya Urban Comparison Child | Behavioral Difficulties | Baseline Score | 0.15 Score on a scale |
| Kenya Urban Comparison Child | Behavioral Difficulties | Mean Change in Score | -0.05 Score on a scale |
| Kenya Urban Comparison Child | Behavioral Difficulties | Post-Treatment Score | 0.09 Score on a scale |
| Kenya Rural TF-CBT Child | Behavioral Difficulties | Post-Treatment Score | 0.11 Score on a scale |
| Kenya Rural TF-CBT Child | Behavioral Difficulties | Baseline Score | 0.18 Score on a scale |
| Kenya Rural TF-CBT Child | Behavioral Difficulties | Mean Change in Score | -0.07 Score on a scale |
| Kenya Urban TF-CBT Child | Behavioral Difficulties | Post-Treatment Score | 0.14 Score on a scale |
| Kenya Urban TF-CBT Child | Behavioral Difficulties | Mean Change in Score | -0.07 Score on a scale |
| Kenya Urban TF-CBT Child | Behavioral Difficulties | Baseline Score | 0.21 Score on a scale |
| Tanzania Rural Comparison Caregiver | Behavioral Difficulties | Mean Change in Score | -0.03 Score on a scale |
| Tanzania Rural Comparison Caregiver | Behavioral Difficulties | Baseline Score | 0.15 Score on a scale |
| Tanzania Rural Comparison Caregiver | Behavioral Difficulties | Post-Treatment Score | 0.12 Score on a scale |
| Tanzania Urban Comparison Caregiver | Behavioral Difficulties | Baseline Score | 0.16 Score on a scale |
| Tanzania Urban Comparison Caregiver | Behavioral Difficulties | Post-Treatment Score | 0.10 Score on a scale |
| Tanzania Urban Comparison Caregiver | Behavioral Difficulties | Mean Change in Score | -0.07 Score on a scale |
| Tanzania Rural TF-CBT Caregiver | Behavioral Difficulties | Mean Change in Score | -0.02 Score on a scale |
| Tanzania Rural TF-CBT Caregiver | Behavioral Difficulties | Baseline Score | 0.12 Score on a scale |
| Tanzania Rural TF-CBT Caregiver | Behavioral Difficulties | Post-Treatment Score | 0.09 Score on a scale |
| Tanzania Urban TF-CBT Caregiver | Behavioral Difficulties | Mean Change in Score | -0.09 Score on a scale |
| Tanzania Urban TF-CBT Caregiver | Behavioral Difficulties | Baseline Score | 0.17 Score on a scale |
| Tanzania Urban TF-CBT Caregiver | Behavioral Difficulties | Post-Treatment Score | 0.09 Score on a scale |
| Kenya Rural Comparison Caregiver | Behavioral Difficulties | Mean Change in Score | 0.03 Score on a scale |
| Kenya Rural Comparison Caregiver | Behavioral Difficulties | Baseline Score | 0.14 Score on a scale |
| Kenya Rural Comparison Caregiver | Behavioral Difficulties | Post-Treatment Score | 0.16 Score on a scale |
| Kenya Urban Comparison Caregiver | Behavioral Difficulties | Baseline Score | 0.18 Score on a scale |
| Kenya Urban Comparison Caregiver | Behavioral Difficulties | Mean Change in Score | -0.05 Score on a scale |
| Kenya Urban Comparison Caregiver | Behavioral Difficulties | Post-Treatment Score | 0.13 Score on a scale |
| Kenya Rural TF-CBT Caregiver | Behavioral Difficulties | Baseline Score | 0.13 Score on a scale |
| Kenya Rural TF-CBT Caregiver | Behavioral Difficulties | Post-Treatment Score | 0.11 Score on a scale |
| Kenya Rural TF-CBT Caregiver | Behavioral Difficulties | Mean Change in Score | -0.02 Score on a scale |
| Kenya Urban TF-CBT Caregiver | Behavioral Difficulties | Mean Change in Score | -0.11 Score on a scale |
| Kenya Urban TF-CBT Caregiver | Behavioral Difficulties | Baseline Score | 0.25 Score on a scale |
| Kenya Urban TF-CBT Caregiver | Behavioral Difficulties | Post-Treatment Score | 0.14 Score on a scale |
Other Pre-specified
Child Functioning
Locally developed tool used to measure functional impairment and improvement over time.
Time frame: Baseline, 3 months
Other Pre-specified
Child-Guardian Relationship
Measured using the Child-Parent Relationship Scale (CPRS)
Time frame: Baseline, 3 months
Other Pre-specified
Depression
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).
Time frame: Baseline, 3 months
Population: Children and Caregivers from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tanzania Rural Comparison Child | Depression | Baseline Score | 0.23 Score on a scale |
| Tanzania Rural Comparison Child | Depression | Mean Change in Score | -0.05 Score on a scale |
| Tanzania Rural Comparison Child | Depression | Post-Treatment Score | 0.18 Score on a scale |
| Tanzania Urban Comparison Child | Depression | Post-Treatment Score | 0.09 Score on a scale |
| Tanzania Urban Comparison Child | Depression | Baseline Score | 0.11 Score on a scale |
| Tanzania Urban Comparison Child | Depression | Mean Change in Score | -0.02 Score on a scale |
| Tanzania Rural TF-CBT Child | Depression | Mean Change in Score | -0.21 Score on a scale |
| Tanzania Rural TF-CBT Child | Depression | Baseline Score | 0.41 Score on a scale |
| Tanzania Rural TF-CBT Child | Depression | Post-Treatment Score | 0.21 Score on a scale |
| Tanzania Urban TF-CBT Child | Depression | Post-Treatment Score | 0.06 Score on a scale |
| Tanzania Urban TF-CBT Child | Depression | Baseline Score | 0.11 Score on a scale |
| Tanzania Urban TF-CBT Child | Depression | Mean Change in Score | -0.05 Score on a scale |
| Kenya Rural Comparison Child | Depression | Mean Change in Score | 0.01 Score on a scale |
| Kenya Rural Comparison Child | Depression | Baseline Score | 0.52 Score on a scale |
| Kenya Rural Comparison Child | Depression | Post-Treatment Score | 0.53 Score on a scale |
| Kenya Urban Comparison Child | Depression | Mean Change in Score | -0.11 Score on a scale |
| Kenya Urban Comparison Child | Depression | Baseline Score | 0.50 Score on a scale |
| Kenya Urban Comparison Child | Depression | Post-Treatment Score | 0.38 Score on a scale |
| Kenya Rural TF-CBT Child | Depression | Baseline Score | 0.63 Score on a scale |
| Kenya Rural TF-CBT Child | Depression | Post-Treatment Score | 0.30 Score on a scale |
| Kenya Rural TF-CBT Child | Depression | Mean Change in Score | -0.33 Score on a scale |
| Kenya Urban TF-CBT Child | Depression | Post-Treatment Score | 0.33 Score on a scale |
| Kenya Urban TF-CBT Child | Depression | Mean Change in Score | -0.32 Score on a scale |
| Kenya Urban TF-CBT Child | Depression | Baseline Score | 0.66 Score on a scale |
| Tanzania Rural Comparison Caregiver | Depression | Post-Treatment Score | 0.17 Score on a scale |
| Tanzania Rural Comparison Caregiver | Depression | Baseline Score | 0.21 Score on a scale |
| Tanzania Rural Comparison Caregiver | Depression | Mean Change in Score | -0.04 Score on a scale |
| Tanzania Urban Comparison Caregiver | Depression | Mean Change in Score | -0.07 Score on a scale |
| Tanzania Urban Comparison Caregiver | Depression | Baseline Score | 0.16 Score on a scale |
| Tanzania Urban Comparison Caregiver | Depression | Post-Treatment Score | 0.10 Score on a scale |
| Tanzania Rural TF-CBT Caregiver | Depression | Baseline Score | 0.20 Score on a scale |
| Tanzania Rural TF-CBT Caregiver | Depression | Post-Treatment Score | 0.15 Score on a scale |
| Tanzania Rural TF-CBT Caregiver | Depression | Mean Change in Score | -0.05 Score on a scale |
| Tanzania Urban TF-CBT Caregiver | Depression | Baseline Score | 0.17 Score on a scale |
| Tanzania Urban TF-CBT Caregiver | Depression | Post-Treatment Score | 0.09 Score on a scale |
| Tanzania Urban TF-CBT Caregiver | Depression | Mean Change in Score | -0.09 Score on a scale |
| Kenya Rural Comparison Caregiver | Depression | Post-Treatment Score | 0.55 Score on a scale |
| Kenya Rural Comparison Caregiver | Depression | Baseline Score | 0.48 Score on a scale |
| Kenya Rural Comparison Caregiver | Depression | Mean Change in Score | 0.07 Score on a scale |
| Kenya Urban Comparison Caregiver | Depression | Baseline Score | 0.48 Score on a scale |
| Kenya Urban Comparison Caregiver | Depression | Post-Treatment Score | 0.36 Score on a scale |
| Kenya Urban Comparison Caregiver | Depression | Mean Change in Score | -0.12 Score on a scale |
| Kenya Rural TF-CBT Caregiver | Depression | Baseline Score | 0.48 Score on a scale |
| Kenya Rural TF-CBT Caregiver | Depression | Mean Change in Score | -0.20 Score on a scale |
| Kenya Rural TF-CBT Caregiver | Depression | Post-Treatment Score | 0.28 Score on a scale |
| Kenya Urban TF-CBT Caregiver | Depression | Post-Treatment Score | 0.32 Score on a scale |
| Kenya Urban TF-CBT Caregiver | Depression | Baseline Score | 0.58 Score on a scale |
| Kenya Urban TF-CBT Caregiver | Depression | Mean Change in Score | -0.26 Score on a scale |