Trial Outcomes & Findings for Building and Sustaining Interventions for Children: Task-sharing Mental Health Care in Low-resource Settings (NCT NCT03243396)

Results Overview

Severity of posttraumatic stress symptoms, as assessed by the Child and Adolescent Trauma Screen (child report), including additional items validated locally. Higher scores represent more severe symptoms. The range of scores is 0 to 66. Scores are the sum of 22 items asking about how often specific things have bothered someone in the past 4 weeks. Each item is measured on a scale of 0 to 3, where 0=never happens and 3=almost always.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

956 participants

Primary outcome timeframe

Baseline, End of 8-session Treatment (assessed up to 18 weeks)

Results posted on

2025-04-01

Participant Flow

Children believed to be eligible were recruited using school enrollment lists, with the additional assistance of teachers and community health volunteers (CHVs) to confirm and locate them.

Due to the Stepped Wedge design, participants in Sequences 2-7 may have been screened twice: First, when their site served as a Comparison, and second, when their site was allocated to Intervention. Therefore, some children only contributed information at Comparison timepoints; if they were unavailable or ineligible when their site implemented, they were not randomized to receive the intervention via either delivery sector. Lost to follow-up refers to not completing the end-of-treatment survey.

Unit of analysis: Number of Sites

Participant milestones

Participant milestones
Measure	Sequence 1 March 26, 2018 - August 27, 2018 (Staggered delivery periods, with 8 once-per-week sessions per delivery period. Each site had separate girls and boys groups in both the health and education sector, for 4 total delivery periods in this sequence.)	Sequence 2 January 28, 2019 - June 30, 2019 (Staggered delivery periods, with 8 once-per-week sessions per delivery period. Each site had separate girls and boys groups in both the health and education sector, for 4 total delivery periods in this sequence.)	Sequence 3 May 6, 2019 - October 18, 2019 (Staggered delivery periods, with 8 once-per-week sessions per delivery period. Each site had separate girls and boys groups in both the health and education sector, for 4 total delivery periods in this sequence.)	Sequence 4 January 27, 2020 - March 17, 2021 (Staggered delivery periods, with 8 once-per-week sessions per delivery period. Each site had separate girls and boys groups in both the health and education sector, for 4 total delivery periods in this sequence.) \*Note: This Sequence experienced a prolonged hiatus due to the impact of COVID-19 on the school schedule in Kenya	Sequence 5 January 28, 2021 - July 6, 2021 (Staggered delivery periods, with 8 once-per-week sessions per delivery period. Each site had separate girls and boys groups in both the health and education sector, for 4 total delivery periods in this sequence.) \*Note: This Sequence was delayed due to the impact of COVID-19 on the school schedule in Kenya	Sequence 6 May 27, 2021 - September 22, 2021 dates (Staggered delivery periods, with 8 once-per-week sessions per delivery period. Each site had separate girls and boys groups in both the health and education sector, for 4 total delivery periods in this sequence.) \*Note: This Sequence was delayed due to the impact of COVID-19 on the school schedule in Kenya	Sequence 7 October 27, 2021 - February 28, 2022 (Staggered delivery periods, with 8 once-per-week sessions per delivery period. Each site had separate girls and boys groups in both the health and education sector, for 4 total delivery periods in this sequence.) \*Note: This Sequence was delayed due to the impact of COVID-19 on the school schedule in Kenya
Overall Study STARTED	258 10	151 5	134 5	127 5	117 5	85 5	84 5
Overall Study COMPLETED	256 10	148 5	119 5	119 5	116 5	81 5	75 5
Overall Study NOT COMPLETED	2 0	3 0	15 0	8 0	1 0	4 0	9 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sequence 1 March 26, 2018 - August 27, 2018 (Staggered delivery periods, with 8 once-per-week sessions per delivery period. Each site had separate girls and boys groups in both the health and education sector, for 4 total delivery periods in this sequence.)	Sequence 2 January 28, 2019 - June 30, 2019 (Staggered delivery periods, with 8 once-per-week sessions per delivery period. Each site had separate girls and boys groups in both the health and education sector, for 4 total delivery periods in this sequence.)	Sequence 3 May 6, 2019 - October 18, 2019 (Staggered delivery periods, with 8 once-per-week sessions per delivery period. Each site had separate girls and boys groups in both the health and education sector, for 4 total delivery periods in this sequence.)	Sequence 4 January 27, 2020 - March 17, 2021 (Staggered delivery periods, with 8 once-per-week sessions per delivery period. Each site had separate girls and boys groups in both the health and education sector, for 4 total delivery periods in this sequence.) \*Note: This Sequence experienced a prolonged hiatus due to the impact of COVID-19 on the school schedule in Kenya	Sequence 5 January 28, 2021 - July 6, 2021 (Staggered delivery periods, with 8 once-per-week sessions per delivery period. Each site had separate girls and boys groups in both the health and education sector, for 4 total delivery periods in this sequence.) \*Note: This Sequence was delayed due to the impact of COVID-19 on the school schedule in Kenya	Sequence 6 May 27, 2021 - September 22, 2021 dates (Staggered delivery periods, with 8 once-per-week sessions per delivery period. Each site had separate girls and boys groups in both the health and education sector, for 4 total delivery periods in this sequence.) \*Note: This Sequence was delayed due to the impact of COVID-19 on the school schedule in Kenya	Sequence 7 October 27, 2021 - February 28, 2022 (Staggered delivery periods, with 8 once-per-week sessions per delivery period. Each site had separate girls and boys groups in both the health and education sector, for 4 total delivery periods in this sequence.) \*Note: This Sequence was delayed due to the impact of COVID-19 on the school schedule in Kenya
Overall Study Lost to Follow-up	2	3	15	8	1	4	9

Baseline Characteristics

Building and Sustaining Interventions for Children: Task-sharing Mental Health Care in Low-resource Settings

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Youth Randomized to Health-Sector Delivered CBT n=413 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Randomized to Education-Sector Delivered CBT n=438 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBT n=105 Participants These child/adolescent participants and one of their guardians did not receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy.	Total n=956 Participants Total of all reporting groups
Age, Continuous	12.4 years STANDARD_DEVIATION 1.1 • n=5 Participants	12.5 years STANDARD_DEVIATION 1.1 • n=7 Participants	13.1 years STANDARD_DEVIATION 1.1 • n=5 Participants	12.5 years STANDARD_DEVIATION 1.1 • n=4 Participants
Sex: Female, Male Female	197 Participants n=5 Participants	221 Participants n=7 Participants	66 Participants n=5 Participants	484 Participants n=4 Participants
Sex: Female, Male Male	216 Participants n=5 Participants	217 Participants n=7 Participants	39 Participants n=5 Participants	472 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	413 Participants n=5 Participants	438 Participants n=7 Participants	105 Participants n=5 Participants	956 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	413 Participants n=5 Participants	438 Participants n=7 Participants	105 Participants n=5 Participants	956 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Kenya	413 Participants n=5 Participants	438 Participants n=7 Participants	105 Participants n=5 Participants	956 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, End of 8-session Treatment (assessed up to 18 weeks)

Severity of posttraumatic stress symptoms, as assessed by the Child and Adolescent Trauma Screen (child report), including additional items validated locally. Higher scores represent more severe symptoms. The range of scores is 0 to 66. Scores are the sum of 22 items asking about how often specific things have bothered someone in the past 4 weeks. Each item is measured on a scale of 0 to 3, where 0=never happens and 3=almost always.

Outcome measures

Outcome measures
Measure	Youth Randomized to Health-Sector Delivered CBT n=413 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Randomized to Education-Sector Delivered CBT n=438 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBT n=105 Participants These child/adolescent participants and one of their guardians did not receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy.
Change in Posttraumatic Stress Symptoms (Child Report)	-13.2 score on a scale Interval -14.4 to -12.1	-12.8 score on a scale Interval -13.9 to -11.6	-6.9 score on a scale Interval -9.5 to -4.3

PRIMARY outcome

Timeframe: End of first year of site implementation (2 groups, 8 sessions each)

Population: This is a site-level outcome. Teams of 3 counselors delivered the intervention in each site. They were observed and scored as a group-based observation.

Ability of the group leader to adhere to established Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) protocols and guidelines, as assessed by the Fidelity and Adherence Rating Scales developed by the study team. Assessed in each observed TF-CBT session by supervisors. Higher scores represent higher adherence to TF-CBT. Adherence is measured on a scale of 0 to 6. Scores reported are observations of Child groups.

Outcome measures

Outcome measures
Measure	Youth Randomized to Health-Sector Delivered CBT n=39 Sites These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Randomized to Education-Sector Delivered CBT n=39 Sites These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBT These child/adolescent participants and one of their guardians did not receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy.
Fidelity	4.1 score on a scale Interval 3.9 to 4.2	4.4 score on a scale Interval 4.3 to 4.6	—

PRIMARY outcome

Timeframe: End of first year of site implementation (2 groups, 8 sessions each)

Population: This is a site level outcome indicating whether the 3-counselor team in each sector implemented the 8 sessions.

Adoption is a binary yes/no outcome defined as initiating and delivering the 8-session TF-CBT groups by a 3-counselor team and is measured by counselor self-report (and confirmed by supervisors who observed groups). Assessed for each "trimester" end for schools and communities, summarized over the year. We report the number of sites out of 40 total that adopted the intervention.

Outcome measures

Outcome measures
Measure	Youth Randomized to Health-Sector Delivered CBT n=40 Sites These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Randomized to Education-Sector Delivered CBT n=40 Sites These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBT These child/adolescent participants and one of their guardians did not receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy.
Number of Sites That Adopted the Intervention	40 Sites	40 Sites	—

PRIMARY outcome

Timeframe: Two years after the first TF-CBT groups for each site

Population: This is a site level outcome indicating whether the 3-counselor team in each sector maintained delivery 2 years after the study intervention period.

Sustainment is a binary yes/no outcome defined as maintained delivery 2 years after the study intervention period (2 groups delivered within a calendar year, with at least 80% capacity as compared to their group enrollment during initial implementation). It is measured by counselor self-report (and confirmed by supervisors). At times the number of youth that would be 80% enrolled required rounding down to the nearest whole person. We report the number of sites out of 40 total that sustained the intervention.

Outcome measures

Outcome measures
Measure	Youth Randomized to Health-Sector Delivered CBT n=40 Sites These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Randomized to Education-Sector Delivered CBT n=40 Sites These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBT These child/adolescent participants and one of their guardians did not receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy.
Number of Sites That Sustained the Intervention	16 Sites	10 Sites	—

SECONDARY outcome

Timeframe: Baseline, End of 8-session Treatment (assessed up to 18 weeks)

Severity of posttraumatic stress symptoms, as assessed by the Child and Adolescent Trauma Screen (caregiver report), including additional items validated locally. Higher scores represent more severe symptoms. The range of scores is 0 to 66. Scores are the sum of 22 items asking about how often specific things have bothered someone in the past 4 weeks. Each item is measured on a scale of 0 to 3, where 0=never happens and 3=almost always.

Outcome measures

Outcome measures
Measure	Youth Randomized to Health-Sector Delivered CBT n=413 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Randomized to Education-Sector Delivered CBT n=438 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBT n=105 Participants These child/adolescent participants and one of their guardians did not receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy.
Change in Posttraumatic Stress Symptoms (Caregiver Report)	-17.1 score on a scale Interval -18.3 to -16.0	-17.1 score on a scale Interval -18.3 to -16.0	-8.4 score on a scale Interval -11.9 to -5.0

SECONDARY outcome

Timeframe: Baseline, End of 8-session Treatment (assessed up to 18 weeks)

Level of experienced depressive symptoms, as assessed by the Adolescent version of the Patient Health Questionnaire (8-question version) and additional items validated locally. Higher scores represent more severe symptoms. The range of scores is 0 to 36. Scores are the sum of 12 item asking how often items have bothered someone in the past 2 weeks. Each item is measured on a scale of 0 to 3, where 0=not at all happens and 3=nearly every day.

Outcome measures

Outcome measures
Measure	Youth Randomized to Health-Sector Delivered CBT n=413 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Randomized to Education-Sector Delivered CBT n=438 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBT n=105 Participants These child/adolescent participants and one of their guardians did not receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy.
Change in Depressive Symptoms (Child Report)	-3.6 score on a scale Interval -4.3 to -2.9	-3.3 score on a scale Interval -4.0 to -2.5	-2.3 score on a scale Interval -4.0 to -0.5

SECONDARY outcome

Timeframe: Baseline, End of 8-session Treatment (assessed up to 18 weeks)

Level of grief related to a traumatic event experienced by the child, as assessed by the Inventory of Complex Grief. Higher scores represent more severe symptoms. The range of scores is 0 to 112. Scores are the sum of 28 items asking about how often they have experienced each item past month. Each item is measured on a scale of 0 to 4, where 0=almost never (less than once a month) and 4=always (several times a day).

Outcome measures

Outcome measures
Measure	Youth Randomized to Health-Sector Delivered CBT n=413 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Randomized to Education-Sector Delivered CBT n=438 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBT n=105 Participants These child/adolescent participants and one of their guardians did not receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy.
Change in Grief (Child Report)	-23.0 score on a scale Interval -24.9 to -21.0	-22.9 score on a scale Interval -25.0 to -20.8	-10.8 score on a scale Interval -16.1 to -5.5

SECONDARY outcome

Timeframe: Immediately Post-Training (on final day of training for the sequence, up to 6 days)

Population: This is a group leader-level outcome.

Test of the level of knowledge of the lay counselors about TF-CBT, as assessed by the TF-CBT Knowledge Assessment. Higher scores represent greater group leader knowledge of TF-CBT. Scores could range from 0 to 32.5. The knowledge test was administered to all lay counselors at the end of their TF-CBT training to confirm their readiness to deliver the intervention. For each sequence, training occurred just before implementation of the intervention.

Outcome measures

Outcome measures
Measure	Youth Randomized to Health-Sector Delivered CBT n=97 Group Leaders These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Randomized to Education-Sector Delivered CBT n=104 Group Leaders These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBT These child/adolescent participants and one of their guardians did not receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy.
TF-CBT Knowledge Score	25.1 score on a scale Interval 24.4 to 25.8	27.8 score on a scale Interval 27.1 to 28.4	—

SECONDARY outcome

Timeframe: Baseline, End of 8-session Treatment (assessed up to 18 weeks)

Change in behavioral strengths of the child, as assessed by the Prosocial Behavior subscale of the Strengths and Difficulties Questionnaire before and after the intervention. There are 5 items asking about the degree to which the child reports prosocial behavior. Each item has 3 possible responses on a scale of 0 to 2, where 0=not at all true and 2=certainly true. The total score summing across the 5 items could range from 0 to 10. Higher scores are more favorable, representing more prosocial behavior.

Outcome measures

Outcome measures
Measure	Youth Randomized to Health-Sector Delivered CBT n=413 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Randomized to Education-Sector Delivered CBT n=438 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBT n=105 Participants These child/adolescent participants and one of their guardians did not receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy.
Change in Prosocial Behavior (Child Report)	0.09 score on a scale Interval -0.1 to 0.3	0.2 score on a scale Interval 0.03 to 0.4	0.2 score on a scale Interval -0.2 to 0.6

SECONDARY outcome

Timeframe: Baseline, End of 8-session Treatment (assessed up to 18 weeks)

Change in behavioral problems of the child, as assessed by the Conduct Problems subscale of the Strengths and Difficulties Questionnaire, including additional items validated locally. There are 9 items asking about the degree to which the guardian reports conduct problems observed in the child. Each item has 3 possible responses on a scale of 0 to 2, where 0=not at all true and 2=certainly true. The total score summing across the 5 items could range from 0 to 18. Lower scores are more favorable, representing decreased behavioral problems.

Outcome measures

Outcome measures
Measure	Youth Randomized to Health-Sector Delivered CBT n=413 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Randomized to Education-Sector Delivered CBT n=438 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBT n=105 Participants These child/adolescent participants and one of their guardians did not receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy.
Change in Behavioral Problems (Guardian Report)	-0.9 score on a scale Interval -1.1 to -0.7	-0.7 score on a scale Interval -0.9 to -0.5	-0.04 score on a scale Interval -0.5 to 0.6

SECONDARY outcome

Timeframe: Baseline

School attendance measured by the number of school days missed in the past two weeks, as reported by the guardian.

Outcome measures

Outcome measures
Measure	Youth Randomized to Health-Sector Delivered CBT n=413 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Randomized to Education-Sector Delivered CBT n=438 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBT n=105 Participants These child/adolescent participants and one of their guardians did not receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy.
School Attendance	2.1 days Interval 1.8 to 2.4	1.9 days Interval 1.6 to 2.2	1.1 days Interval 0.7 to 1.5

SECONDARY outcome

Timeframe: Baseline to third annual follow-up

Population: Participants who were assessed at the third annual follow-up and were at least 16 years old at follow-up time.

Change in proportion of children engaged in excessive child labor for pay in the past week, as assessed by the Child Work and Labor Questionnaire and reported by the child. UNICEF's definition of excessive labor for children aged 12 and older is 14 hours per week for pay and 28 hours per week with or without pay. This is constructed as a binary variable, and we present a difference in the proportion of children who worked 14 or more hours in the past week for income-generating activities (work without pay was not assessed). Lower proportion is more favorable, representing fewer children engaged in excessive child labor for pay.

Outcome measures

Outcome measures
Measure	Youth Randomized to Health-Sector Delivered CBT n=129 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Randomized to Education-Sector Delivered CBT n=142 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBT n=25 Participants These child/adolescent participants and one of their guardians did not receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy.
Change in Proportion of Children Engaged in Excessive Child Labor for Pay	0.1 proportion of youth Interval 0.05 to 0.2	0.09 proportion of youth Interval 0.03 to 0.2	0.12 proportion of youth Interval 0.01 to 0.3

SECONDARY outcome

Timeframe: Baseline to third annual follow-up

Population: Participants who were assessed at the third annual follow-up and were at least 16 years old at follow-up time.

Change in proportion of children engaged in chores (non-income generating work around the home) in the past week, as reported by the child. This is constructed as a binary variable, and we present a difference in the proportion of children who did chores for 14 or more hours in the past week. Lower proportion is more favorable, representing fewer children engaged in excessive household assistance without pay.

Outcome measures

Outcome measures
Measure	Youth Randomized to Health-Sector Delivered CBT n=129 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Randomized to Education-Sector Delivered CBT n=142 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBT n=25 Participants These child/adolescent participants and one of their guardians did not receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy.
Change in Proportion of Children Engages in Excessive Household Assistance Without Pay	0.3 proportion of youth Interval 0.2 to 0.5	0.3 proportion of youth Interval 0.2 to 0.4	0.2 proportion of youth Interval -0.07 to 0.6

SECONDARY outcome

Timeframe: Third annual follow-up

Population: Participants who were assessed at the third annual follow-up and were at least 16 years old at follow-up time.

Agreement exhibited by the child with positive peer norms regarding sexual behavior, as assessed by the Safer Sex Peer Norms subscale on the Safer Sex Peer Norms and Substance Use Questionnaire. This measure is only administered if the child is 16 or older, so for this outcome, we report specifically on the Safer Sex Peer Norms assessment collected at the 3rd annual follow-up timepoint. Scores are the sum of 7-item asking about agreement with the item. Each item is measured on a scale of 1 to 4, where 1=strongly disagree and 4=strongly agree. The range of total scores is 0 to 28. Higher scores are more favorable, representing stronger agreement with positive peer norms.

Outcome measures

Outcome measures
Measure	Youth Randomized to Health-Sector Delivered CBT n=124 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Randomized to Education-Sector Delivered CBT n=137 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBT n=23 Participants These child/adolescent participants and one of their guardians did not receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy.
Safer Sex Peer Norms Score	16.3 score on a scale Interval 15.6 to 17.1	16.7 score on a scale Interval 16.0 to 17.4	16.5 score on a scale Interval 14.9 to 18.1

SECONDARY outcome

Timeframe: Baseline to third annual follow-up

Population: Participants who were assessed at the third annual follow-up and were at least 16 years old at follow-up time.

Change in proportion of children reporting any current alcohol, tobacco, or other drug use, as assessed by the Safer Sex Peer Norms and Substance Use Questionnaire and reported by the child. This is reported as a binary variable representing the proportion of children who report current drug use or drinking alcohol in the past 7 days or using tobacco in the past 7 days. Lower proportion is more favorable.

Outcome measures

Outcome measures
Measure	Youth Randomized to Health-Sector Delivered CBT n=129 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in a community setting from Community Health Volunteers. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Randomized to Education-Sector Delivered CBT n=142 Participants These child/adolescent participants and one of their guardians will receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy, in their school setting from teachers employed by their school. Trauma-Focused Cognitive Behavioral Therapy: Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).	Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBT n=25 Participants These child/adolescent participants and one of their guardians did not receive Pamoja Tunaweza, the locally adapted version of Trauma-Focused Cognitive Behavioral Therapy.
Change in Proportion of Children Reporting Any Current Substance Use	-0.01 proportion of youth Interval -0.05 to 0.02	-0.02 proportion of youth Interval -0.03 to 0.01	0.0 proportion of youth Interval 0.0 to 0.0

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathryn Whetten, PhD, MPH

Duke University

Phone: 919-613-5313

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place