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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH096633 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Tanzania Women Research Foundation (TAWREF) | UNKNOWN |
| Ace Africa | OTHER |
| University of Washington |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Comparison Condition | No Intervention | Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control. | |
| Trauma-focused CBT group therapy | Experimental | Half of the participating children/guardian dyads will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trauma-focused Cognitive Behavioral Therapy | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 months |
| 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. | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shannon Dorsey, PhD | University of Washington | Principal Investigator |
| Kate Whetten, PhD, MPH | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington Department of Psychology | Seattle | Washington | 98195 | United States | ||
| Action in the Community Environment (ACE) Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31968059 | Derived | Dorsey S, Lucid L, Martin P, King KM, O'Donnell K, Murray LK, Wasonga AI, Itemba DK, Cohen JA, Manongi R, Whetten K. Effectiveness of Task-Shifted Trauma-Focused Cognitive Behavioral Therapy for Children Who Experienced Parental Death and Posttraumatic Stress in Kenya and Tanzania: A Randomized Clinical Trial. JAMA Psychiatry. 2020 May 1;77(5):464-473. doi: 10.1001/jamapsychiatry.2019.4475. |
| Label | URL |
|---|---|
| Pamoja Tunaweza (Together We Can) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care Comparison Condition - Children | Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control. |
| FG001 | Trauma-focused CBT Group Therapy - Children |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 3, 2011 |
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| OTHER |
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| Baseline, 3 months |
| Baseline, 3 months |
| Child Functioning | Locally developed tool used to measure functional impairment and improvement over time. | Baseline, 3 months |
| Child-Guardian Relationship | Measured using the Child-Parent Relationship Scale (CPRS) | Baseline, 3 months |
| Bungoma |
| Kenya |
| Tanzania Women Research Foundation (TAWREF) | Moshi | Tanzania |
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
| FG002 | Usual Care Comparison Condition - Caregivers | Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control. |
| FG003 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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Caregivers and Children were treated as dyads for the study, but have been categorized separately here for the purpose of reporting results.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care Comparison Condition - Children | Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control. |
| BG001 | 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 |
| BG002 | Usual Care Comparison Condition - Caregivers | Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control. |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Child age missing for 2 comparison and 2 intervention participants. | Count of Participants | Participants |
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| Age, Continuous | Child age missing for 2 comparison and 2 intervention participants. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Children and Caregivers from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban) | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 3 months |
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| 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. | Children from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban) | Posted | Mean | 95% Confidence Interval | Score on a scale | Baseline, 3 months |
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| 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). | Children and Caregivers from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban) | Posted | Mean | 95% Confidence Interval | Score on a scale | Baseline, 3 months |
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| 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). | Children and Caregivers from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban) | Posted | Mean | 95% Confidence Interval | Score on a scale | Baseline, 3 months |
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| Other Pre-specified | Child Functioning | Locally developed tool used to measure functional impairment and improvement over time. | Not Posted | Baseline, 3 months | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Child-Guardian Relationship | Measured using the Child-Parent Relationship Scale (CPRS) | Not Posted | Baseline, 3 months | Participants |
1 year, 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care Comparison Condition | Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control. | 0 | 640 | 0 | 640 | 0 | 640 |
| EG001 | Trauma-focused CBT Group Therapy | 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 | 0 | 640 | 0 | 640 | 0 | 640 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shannon Dorsey | University of Washington | (206) 543-4527 | dorsey2@uw.edu |
| May 31, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| D000066553 | Problem Behavior |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D002652 | Child Behavior |
| D010549 | Personal Satisfaction |
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| Kenya |
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| Post-Treatment Score |
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| Mean Change in Score |
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| Tanzania Urban TF-CBT Child |
Half of the participating children will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment. Trauma-focused Cognitive Behavioral Therapy |
| OG004 | Kenya Rural Comparison Child | Half of the participating children will receive no intervention (usual care) to serve as a control. |
| OG005 | Kenya Urban Comparison Child | Half of the participating children will receive no intervention (usual care) to serve as a control. |
| OG006 | Kenya Rural TF-CBT Child | Half of the participating children will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment. Trauma-focused Cognitive Behavioral Therapy |
| OG007 | Kenya Urban TF-CBT Child | Half of the participating children will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment. Trauma-focused Cognitive Behavioral Therapy |
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| Tanzania Rural TF-CBT Child |
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 |
| OG003 | Tanzania Urban TF-CBT Child | 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 |
| OG004 | Kenya Rural Comparison Child | Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control. |
| OG005 | Kenya Urban Comparison Child | Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control. |
| OG006 | Kenya Rural TF-CBT Child | 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 |
| OG007 | Kenya Urban TF-CBT Child | 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 |
| OG008 | Tanzania Rural Comparison Caregiver | Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control. |
| OG009 | Tanzania Urban Comparison Caregiver | Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control. |
| OG010 | 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 |
| OG011 | 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 |
| OG012 | Kenya Rural Comparison Caregiver | Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control. |
| OG013 | Kenya Urban Comparison Caregiver | Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control. |
| OG014 | 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 |
| OG015 | 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 |
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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 |
| OG003 | Tanzania Urban TF-CBT Child | 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 |
| OG004 | Kenya Rural Comparison Child | Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control. |
| OG005 | Kenya Urban Comparison Child | Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control. |
| OG006 | Kenya Rural TF-CBT Child | 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 |
| OG007 | Kenya Urban TF-CBT Child | 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 |
| OG008 | Tanzania Rural Comparison Caregiver | Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control. |
| OG009 | Tanzania Urban Comparison Caregiver | Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control. |
| OG010 | 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 |
| OG011 | 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 |
| OG012 | Kenya Rural Comparison Caregiver | Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control. |
| OG013 | Kenya Urban Comparison Caregiver | Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control. |
| OG014 | 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 |
| OG015 | 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 |
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