Randomized Controlled Trial of Trauma-focused CBT in Tanzania and Kenya

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01822366
• Collaborator: National Institute of Mental Health (NIMH) (NIH), Tanzania Women Research Foundation (TAWREF) (Other), Ace Africa (Other), University of Washington (Other)
• Enrollment: 1,280
• Locations: 3
• Arms: 2
• Actual Duration (Months): 51
• Patients Per Site: 426.7
• Patients Per Site Per Month: 8.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Traumatic Grief; Post Traumatic Stress; Post Traumatic Stress Disorder; Depressive Symptoms; Behavioral Problems; Child Overall Daily Functioning; Child and Guardian Relationship	Behavioral: Trauma-focused Cognitive Behavioral Therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1280 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving Health Outcomes by Preventing HIV/STD Risk
• Actual Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Care Comparison Condition Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.
Experimental: 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.	Behavioral: Trauma-focused Cognitive Behavioral Therapy

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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 Outcome Measures

1. 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).

2. Child Functioning [Baseline, 3 months]

   Locally developed tool used to measure functional impairment and improvement over time.

3. Child-Guardian Relationship [Baseline, 3 months]

   Measured using the Child-Parent Relationship Scale (CPRS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 13 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Washington Department of Psychology	Seattle	Washington	United States	98195
2	Action in the Community Environment (ACE) Africa	Bungoma		Kenya
3	Tanzania Women Research Foundation (TAWREF)	Moshi		Tanzania

Sponsors and Collaborators

• Duke University
• National Institute of Mental Health (NIMH)
• Tanzania Women Research Foundation (TAWREF)
• Ace Africa
• University of Washington

Investigators

• Principal Investigator: Shannon Dorsey, PhD, University of Washington
• Principal Investigator: Kate Whetten, PhD, MPH, Duke University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 3, 2011

More Information

Additional Information:

• Pamoja Tunaweza (Together We Can)

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01822366
• Other Study ID Numbers: Pro00039770; R01MH096633
• First Posted: Apr 2, 2013
• Last Update Posted: May 5, 2021
• Last Verified: Apr 1, 2021

• Keywords provided by Duke University: 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
• Additional relevant MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Depression; Problem Behavior

Study Results

Participant Flow

Arm/Group Title	Usual Care Comparison Condition - Children	Trauma-focused CBT Group Therapy - Children	Usual Care Comparison Condition - Caregivers	Trauma-focused CBT Group Therapy - Caregivers
Arm/Group Description	Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.	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	Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.	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
Period Title: Overall Study
STARTED	320	320	320	320
COMPLETED	315	298	315	298
NOT COMPLETED	5	22	5	22

Baseline Characteristics

Arm/Group Title	Usual Care Comparison Condition - Children	Trauma-focused CBT Group Therapy - Children	Usual Care Comparison Condition - Caregivers	Trauma-focused CBT Group Therapy - Caregivers	Total
Arm/Group Description	Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.	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	Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.	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 of all reporting groups
Overall Participants	320	320	320	320	1280
Age (Count of Participants)
<=18 years	318 99.4%	318 99.4%	0 0%	0 0%	636 49.7%
Between 18 and 65 years	0 0%	0 0%	298 93.1%	292 91.3%	590 46.1%
>=65 years	0 0%	0 0%	22 6.9%	28 8.8%	50 3.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	10.68 (1.66)	10.58 (1.60)	45.10 (13.34)	44.43 (12.36)	27.75 (19.38)
Sex: Female, Male (Count of Participants)
Female	160 50%	160 50%	288 90%	286 89.4%	894 69.8%
Male	160 50%	160 50%	32 10%	34 10.6%	386 30.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	320 100%	320 100%	320 100%	320 100%	1280 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	320 100%	320 100%	320 100%	320 100%	1280 100%
White	0 0%	0 0%	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Tanzania	160 50%	160 50%	160 50%	160 50%	640 50%
Kenya	160 50%	160 50%	160 50%	160 50%	640 50%

Outcome Measures

1. Primary Outcome

Title	Posttraumatic Stress Syndrome (PTSS)
Description	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

Outcome Measure Data

Analysis Population Description

Children and Caregivers from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban)

Arm/Group Title	Tanzania Rural Comparison Child	Tanzania Urban Comparison Child	Tanzania Rural TF-CBT Child	Tanzania Urban TF-CBT Child	Kenya Rural Comparison Child	Kenya Urban Comparison Child	Kenya Rural TF-CBT Child	Kenya Urban TF-CBT Child	Tanzania Rural Comparison Caregiver	Tanzania Urban Comparison Caregiver	Tanzania Rural TF-CBT Caregiver	Tanzania Urban TF-CBT Caregiver	Kenya Rural Comparison Caregiver	Kenya Urban Comparison Caregiver	Kenya Rural TF-CBT Caregiver	Kenya Urban TF-CBT Caregiver
Arm/Group Description	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	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	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	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	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	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	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	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	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	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	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	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
Measure Participants	64	91	63	96	64	96	64	96	64	91	63	96	64	96	64	96
Baseline Score	23.41	21.23	25.66	23.40	24.61	22.03	24.86	24.70	18.92	18.81	21.33	22.08	23.39	20.61	23.69	21.98
Post-Treatment Score	8.98	12.78	10.17	10.82	22.44	15.92	14.00	12.82	6.94	9.75	5.56	7.80	23.06	14.71	10.77	9.94
Mean Change in Score	-14.40	-8.39	-15.48	-12.53	-2.17	-6.11	-10.86	-11.88	-11.81	-8.77	-15.77	-14.23	-0.33	-5.91	-12.92	-12.04

2. Primary Outcome

Title	Childhood Traumatic Grief
Description	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

Outcome Measure Data

Analysis Population Description

Children from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban)

Arm/Group Title	Tanzania Rural Comparison Child	Tanzania Urban Comparison Child	Tanzania Rural TF-CBT Child	Tanzania Urban TF-CBT Child	Kenya Rural Comparison Child	Kenya Urban Comparison Child	Kenya Rural TF-CBT Child	Kenya Urban TF-CBT Child
Arm/Group Description	Half of the participating children will receive no intervention (usual care) to serve as a control.	Half of the participating children will receive no intervention (usual care) to serve as a control.	Half of the participating children will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment. Trauma-focused Cognitive Behavioral Therapy	Half of the participating children will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment. Trauma-focused Cognitive Behavioral Therapy	Half of the participating children will receive no intervention (usual care) to serve as a control.	Half of the participating children will receive no intervention (usual care) to serve as a control.	Half of the participating children will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment. Trauma-focused Cognitive Behavioral Therapy	Half of the participating children will receive the 12-week Trauma-focused Cognitive Behavioral Therapy (TF-CBT) group treatment. Trauma-focused Cognitive Behavioral Therapy
Measure Participants	64	91	63	96	64	96	64	96
Baseline Score	43.14	40.63	49.17	44.73	42.48	38.34	44.38	42.46
Post-Treatment Score	13.44	22.90	16.00	18.97	38.13	25.19	21.09	20.32
Mean Change in Score	-29.65	-17.25	-33.17	-25.77	-4.36	-13.01	-23.28	-22.14

3. Secondary Outcome

Title	Behavioral Difficulties
Description	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

Outcome Measure Data

Analysis Population Description

Children and Caregivers from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban)

Arm/Group Title	Tanzania Rural Comparison Child	Tanzania Urban Comparison Child	Tanzania Rural TF-CBT Child	Tanzania Urban TF-CBT Child	Kenya Rural Comparison Child	Kenya Urban Comparison Child	Kenya Rural TF-CBT Child	Kenya Urban TF-CBT Child	Tanzania Rural Comparison Caregiver	Tanzania Urban Comparison Caregiver	Tanzania Rural TF-CBT Caregiver	Tanzania Urban TF-CBT Caregiver	Kenya Rural Comparison Caregiver	Kenya Urban Comparison Caregiver	Kenya Rural TF-CBT Caregiver	Kenya Urban TF-CBT Caregiver
Arm/Group Description	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	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	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	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	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	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	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	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	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	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	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	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
Measure Participants	64	91	63	96	64	96	64	96	64	91	63	96	64	96	64	96
Baseline Score	0.07	0.11	0.11	0.11	0.13	0.15	0.18	0.21	0.15	0.16	0.12	0.17	0.14	0.18	0.13	0.25
Post-Treatment Score	0.06	0.09	0.08	0.06	0.13	0.09	0.11	0.14	0.12	0.10	0.09	0.09	0.16	0.13	0.11	0.14
Mean Change in Score	-0.01	-0.02	-0.03	-0.05	0.00	-0.05	-0.07	-0.07	-0.03	-0.07	-0.02	-0.09	0.03	-0.05	-0.02	-0.11

4. Other Pre-specified Outcome

Title	Depression
Description	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

Outcome Measure Data

Analysis Population Description

Children and Caregivers from both comparison and intervention groups in all study settings (Tanzania and Kenya, rural and urban)

Arm/Group Title	Tanzania Rural Comparison Child	Tanzania Urban Comparison Child	Tanzania Rural TF-CBT Child	Tanzania Urban TF-CBT Child	Kenya Rural Comparison Child	Kenya Urban Comparison Child	Kenya Rural TF-CBT Child	Kenya Urban TF-CBT Child	Tanzania Rural Comparison Caregiver	Tanzania Urban Comparison Caregiver	Tanzania Rural TF-CBT Caregiver	Tanzania Urban TF-CBT Caregiver	Kenya Rural Comparison Caregiver	Kenya Urban Comparison Caregiver	Kenya Rural TF-CBT Caregiver	Kenya Urban TF-CBT Caregiver
Arm/Group Description	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	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	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	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	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	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	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	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	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	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	Half of the participating child/caregiver dyads will receive no intervention (usual care) to serve as a control.	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	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
Measure Participants	64	91	63	96	64	96	64	96	64	91	63	96	64	96	64	96
Baseline Score	0.23	0.11	0.41	0.11	0.52	0.50	0.63	0.66	0.21	0.16	0.20	0.17	0.48	0.48	0.48	0.58
Post-Treatment Score	0.18	0.09	0.21	0.06	0.53	0.38	0.30	0.33	0.17	0.10	0.15	0.09	0.55	0.36	0.28	0.32
Mean Change in Score	-0.05	-0.02	-0.21	-0.05	0.01	-0.11	-0.33	-0.32	-0.04	-0.07	-0.05	-0.09	0.07	-0.12	-0.20	-0.26

5. Other Pre-specified Outcome

Title	Child Functioning
Description	Locally developed tool used to measure functional impairment and improvement over time.
Time Frame	Baseline, 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Other Pre-specified Outcome

Title	Child-Guardian Relationship
Description	Measured using the Child-Parent Relationship Scale (CPRS)
Time Frame	Baseline, 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	1 year, 3 months
Arm/Group Title	Usual Care Comparison Condition		Trauma-focused CBT Group Therapy
Arm/Group Description	Half of the participating children/guardian dyads will receive no intervention (usual care) to serve as a control.		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
All Cause Mortality
	Usual Care Comparison Condition		Trauma-focused CBT Group Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/640 (0%)		0/640 (0%)
Serious Adverse Events
	Usual Care Comparison Condition		Trauma-focused CBT Group Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/640 (0%)		0/640 (0%)
Other (Not Including Serious) Adverse Events
	Usual Care Comparison Condition		Trauma-focused CBT Group Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/640 (0%)		0/640 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.