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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03243396
Acronym
BASIC
Enrollment
956
Registered
2017-08-09
Start date
2018-02-01
Completion date
2024-01-25
Last updated
2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Grief, Post Traumatic Stress Disorder, Depression

Keywords

Mental health, Cognitive behavioral therapy, Task-shifting, Global health, Teacher, Community health volunteer, Children, Orphans, Abandoned children, TF-CBT, Mental health policy, Ministry of Education, Ministry of Health, Delivery, Implementation science, Qualitative comparative analysis, Implementation practices and policies, Youth, Adoption, Fidelity, Kenya, Bungoma, Kanduyi, West Africa, Posttraumatic stress, Childhood traumatic grief, Grief, Trauma, Task-sharing, Global mental health

Brief summary

The BASIC study will take place in Kanduyi/Bungoma South Sub-County, in western Kenya, and focuses on children orphaned by one or two parents. Growing evidence demonstrates that orphaned children in low- and middle-income countries are at higher risk of mental health problems, but mental health professionals are largely unavailable in this area. Research suggests that some mental health treatments can be delivered effectively in low- and middle-income countries using a task-shifting approach, in which lay counselors with little or no prior mental health experience are trained to provide treatment, and deliver with supervision. However, very little is known about how to support local systems and organizations in delivering mental health care via task-shifting, particularly in a way that could scale-able and sustainable in the low-resource context. The BASIC team's prior work suggests that partnering with two government sectors, education and health, could be a low-cost and sustainable strategy to implement task-shifted mental health services. By training teachers (via the Education sector) and community health volunteers (via the Health sector) to provide mental health care, a larger population could potentially be reached. Before attempting any country or system-wide implementation, it is important to know what is needed to enable successful implementation in either or both sectors, client outcomes for those receiving mental health care when delivered via Education or Health, and cost of delivery in both sectors. The team aims to collect outcomes that are relevant to policy makers, and that can be considered along with cost and experiences in both sectors.

Detailed description

Building and Sustaining Interventions for Children (BASIC): Task-sharing mental health care in low-resource settings builds on our 15-year history of collaborations with research partners in Kenya, prior NIH-funded work that identified mental health needs of orphaned children in low- and middle-income countries, and iterative and collaborative intervention adaptation and testing using a task-sharing approach, to address these needs.Our goal is to identify locally sustainable implementation policies and practices (IPPs) that lead to effective implementation of task-shared evidence-based treatment (EBT) delivery (a locally adapted version of Trauma-focused Cognitive Behavioral Therapy (TF-CBT), Pamoja Tunaweza in this study) in 2 governmental sectors in Kenya. Both sectors were identified by our Kenyan partners as potential platforms for scale- up-Education via teacher delivery and Health via community health volunteer (CHV) delivery. Both Education and Health may be viable sectors for mental health care delivery, but the IPPs that predict implementation success and intervention effectiveness in either/ both sectors are unknown. This study identifies con-textually relevant, practical, and actionable IPPs that can inform implementation planning, while also assessing child outcomes and intervention costs in both sectors. The recent devolvement of the Kenyan government (leading to more local decision-making), the launch of a National Mental Health Policy, and our Kenyan partners' empowerment work building enthusiasm for TF-CBT are converging to create a local climate in which BASIC could become part of the county plan, if evidence-based guidance for implementation, using mostly existing resources, existed. The trial design is an incomplete stepped wedge cluster randomized controlled trial (SW-CRT) including 40 schools and the 40 surrounding villages. The school and the surrounding community are considered a village cluster. Each of the 40 village clusters has 1 team of teachers and 1 team of CHVs delivering Pamoja Tunaweza, resulting in 120 trained lay counselors in each sector, who provide TF-CBT to 1,280 youth and one of their guardians, across seven sequences of the SW-CRT. Site leaders are enrolled for data collection (up to 80), but do not provide services. The study uses a novel method, qualitative comparative analyses (QCA), that holds potential for substantially advancing the field of implementation science. QCA leverages the rigor of quantitative approaches and the detail of qualitative approaches, and allows for complex causality and equifinality (i.e., an outcome can be reached by multiple means). Study aims are: 1) Identify actionable IPPs that predict adoption (delivery) and fidelity (high- quality delivery) after 10 sites in each sector implement TF-CBT (sequence 1). Use identified IPPs to (Aim 1a) guide implementation planning support for subsequent sites and to (Aim 1b) generate testable hypotheses about IPPs as causal mechanisms; 2) Test mechanisms of implementation success in both sectors across all 7 sequences; and 3) Test TF-CBT effectiveness (i.e., mental health outcomes; functioning) and cost in both sectors. This research has important implications for implementing an evidence-based treatment in low-resource settings, including the US.

Interventions

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).

Sponsors

University of Washington
CollaboratorOTHER
Johns Hopkins University
CollaboratorOTHER
Ace Africa
CollaboratorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH
Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Masking description

No masking--Child/Adolescent participants and their participating guardian will be able to tell to which arm they were allocated or randomized, given that they know from whom they receive treatment (from teachers, indicating Education or from Community Health Volunteers, indicating Health). There are other participant types in addition to children/adolescents and guardians who are enrolled in BASIC (per above description) to answer implementation questions (Aims 1 and 2 of BASIC). As noted above, these other participants include the lay counselors (teachers and Community Health Volunteers, their site leaders \[Education: Head Teachers and Deputy Teachers; Health: Community Health Extension Workers\]).

Intervention model description

Child mental health outcomes are assessed using an incomplete stepped wedge, cluster randomized controlled trial with 7 sequences. Child participants & one guardian each are randomized to receive the treatment (therapy sessions) from lay counselors in the Health (Community Health Volunteer) or Education (teacher) sector, with timing based on the sequence to which their village cluster was randomly assigned. These participants are the focus of the Interventional Study Design in Aim 3. Also included are lay counselors & site leaders (Head Teachers, Deputy Teachers, & Community Health Extension Workers), given that it is a hybrid effectiveness-implementation trial. These participants, the focus of implementation questions in Aims 1 & 2, provide TF-CBT & do not receive therapy sessions themselves. The village clusters are randomized to sequences in the SW-CRT, & if randomized to sequences 2-7, they receive coaching support informed by sequence 1 on how to effectively implement TF-CBT.

Eligibility

Sex/Gender
ALL
Age
11 Years to 14 Years
Healthy volunteers
No

Inclusion criteria

* Child or young adolescent between the ages of 11 and 14 at the time of enrollment * Child lost one or both parents to death at least 6 months ago or later, and when the child was 4 years old or older * Child lives in the community with at least one adult guardian (18 years old or older) * Child is experiencing borderline or clinically significant levels of post-traumatic stress or childhood traumatic grief (as indicated by a score of 18 or higher on the Child Posttraumatic Stress Scale, or a score of 35 or higher on the Inventory of Complicated Grief)

Exclusion criteria

* Child has a known developmental or cognitive disability * Child attends private school * Child and family are about to move * Children who lost a parent less than 6 months ago (since they may be experiencing a normal grief reaction and may not necessarily be in need of the treatment for CTG) * Caregiver of the child refuses to participate * Lay counselor is not literate * Lay counselor does not have a mobile phone * Lay counselor refuses to serve as a counselor * Site leader refuses to allow their site to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Change in Posttraumatic Stress Symptoms (Child Report)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.
Number of Sites That Sustained the InterventionTwo years after the first TF-CBT groups for each siteSustainment 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.
Number of Sites That Adopted the InterventionEnd of first year of site implementation (2 groups, 8 sessions each)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.
FidelityEnd of first year of site implementation (2 groups, 8 sessions each)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.

Secondary

MeasureTime frameDescription
Change in Prosocial Behavior (Child Report)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.
Change in Behavioral Problems (Guardian Report)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.
School AttendanceBaselineSchool attendance measured by the number of school days missed in the past two weeks, as reported by the guardian.
Change in Proportion of Children Engaged in Excessive Child Labor for PayBaseline to third annual follow-upChange 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.
Change in Proportion of Children Engages in Excessive Household Assistance Without PayBaseline to third annual follow-upChange 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.
Safer Sex Peer Norms ScoreThird annual follow-upAgreement 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.
Change in Proportion of Children Reporting Any Current Substance UseBaseline to third annual follow-upChange 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.
Change in Posttraumatic Stress Symptoms (Caregiver Report)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.
Change in Depressive Symptoms (Child Report)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.
Change in Grief (Child Report)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).
TF-CBT Knowledge ScoreImmediately Post-Training (on final day of training for the sequence, up to 6 days)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.

Other

MeasureTime frameDescription
Intervention AppropriatenessEnd of first year of site implementation (2 groups, 8 sessions each)A formative measure is used to assess perceived appropriateness of the TF-CBT intervention at the group leader level, with scores ranging from 1 (least appropriate) to 5 (most appropriate). This is not treated as a scale, and items are analyzed independently of each other. Six items were adapted from the Johns Hopkins University implementation measures that aligned with Proctor and colleagues' (20) definition of appropriateness. Minor changes were made to fit wording to the local context. Two additional items were developed to measure appropriateness domain content for which Johns Hopkins University items did not exist. Given challenges in creating new items, Hujig's Theoretical Domains Framework was used when possible to guide item creation (42). In the resulting 8-item measure, 4 items assessed the perceived fit of delivering TF-CBT with one's role. The additional 4 items assessed the perceived fit of delivering TF-CBT within the specific setting.
Guardian-provided Social SupportEnd of 8-session Treatment (assessed up to 18 weeks)Social support provided to the child by their parent or guardian, as assessed by child report in the Child and Adolescent Social Support Scale. Higher scores represent more support.
Relationship ConflictEnd of 8-session Treatment (assessed up to 18 weeks)Conflict in the child's relationship with their caregiver, as assessed by caregiver report in the Conflict subscale of the Child-Parent Relationship Scale. Higher scores represent more conflict.
Intervention FeasibilityEnd of first year of site implementation (2 groups, 8 sessions each)Assessed using both reflective and formative measures at the group leader level. The reflective measure is the Feasibility of Intervention Measure (FIM), with scores ranging from 1 (least feasible) to 5 (most feasible) calculated as a mean score to reflect the feasibility of implementing TF-CBT in a given setting. The formative measure is the Johns Hopkins University Implementation science scale for Feasibility (using 12 items). This is not treated as a scale, and items are analyzed independently of each other. 2 additional items were included that inquired about the estimated hours per week that respondents felt Pamoja Tunaweza/TF-CBT would require, given the importance of this information for understanding added workload and feasibility for providers in the two contexts (On average, how many hours per week do you spend on Pamoja Tunaweza/TF-CBT \[e.g., preparing for sessions, delivering sessions, and supervision\]?).
Intervention AcceptabilityEnd of first year of site implementation (2 groups, 8 sessions each)Assessed using both reflective and formative measures at the group leader level. The reflective measure is the Acceptability of Intervention Measure (AIM), with scores ranging from 1 (least acceptable) to 5 (most acceptable) calculated as a mean score to reflect the acceptability of the TF-CBT intervention in a given setting. The formative measure is the Johns Hopkins University (JHU) Implementation science case for Acceptability (using only 5 items that mapped directly onto Proctor's definition of acceptability and did not overlap with items on the AIM measure). This is not treated as a scale, and items are analyzed independently of each other.
Relationship ClosenessEnd of 8-session Treatment (assessed up to 18 weeks)Closeness of the child's relationship with their caregiver, as assessed by caregiver report in the Closeness subscale of the Child-Parent Relationship Scale. Higher scores represent greater closeness.

Countries

Kenya

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
Youth Randomized to Health-Sector Delivered CBT
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).
413
Youth Randomized to Education-Sector Delivered CBT
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).
438
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.
105
Total956

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006
Overall StudyLost to Follow-up23158149

Baseline characteristics

CharacteristicYouth Randomized to Health-Sector Delivered CBTTotalYouth Who Were Not Randomized to Receive Pamoja Tunaweza CBTYouth Randomized to Education-Sector Delivered CBT
Age, Continuous12.4 years
STANDARD_DEVIATION 1.1
12.5 years
STANDARD_DEVIATION 1.1
13.1 years
STANDARD_DEVIATION 1.1
12.5 years
STANDARD_DEVIATION 1.1
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
413 Participants956 Participants105 Participants438 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
413 Participants956 Participants105 Participants438 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants0 Participants
Region of Enrollment
Kenya
413 Participants956 Participants105 Participants438 Participants
Sex: Female, Male
Female
197 Participants484 Participants66 Participants221 Participants
Sex: Female, Male
Male
216 Participants472 Participants39 Participants217 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 4130 / 4380 / 105
other
Total, other adverse events
0 / 4130 / 4380 / 105
serious
Total, serious adverse events
0 / 4130 / 4380 / 105

Outcome results

Primary

Change in Posttraumatic Stress Symptoms (Child Report)

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.

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

ArmMeasureValue (MEAN)
Youth Randomized to Health-Sector Delivered CBTChange in Posttraumatic Stress Symptoms (Child Report)-13.2 score on a scale
Youth Randomized to Education-Sector Delivered CBTChange in Posttraumatic Stress Symptoms (Child Report)-12.8 score on a scale
Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBTChange in Posttraumatic Stress Symptoms (Child Report)-6.9 score on a scale
Primary

Fidelity

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.

Time frame: 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.

ArmMeasureValue (MEAN)
Youth Randomized to Health-Sector Delivered CBTFidelity4.1 score on a scale
Youth Randomized to Education-Sector Delivered CBTFidelity4.4 score on a scale
Primary

Number of Sites That Adopted the Intervention

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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_UNITS)
Youth Randomized to Health-Sector Delivered CBTNumber of Sites That Adopted the Intervention40 Sites
Youth Randomized to Education-Sector Delivered CBTNumber of Sites That Adopted the Intervention40 Sites
Primary

Number of Sites That Sustained the Intervention

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.

Time frame: 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.

ArmMeasureValue (COUNT_OF_UNITS)
Youth Randomized to Health-Sector Delivered CBTNumber of Sites That Sustained the Intervention16 Sites
Youth Randomized to Education-Sector Delivered CBTNumber of Sites That Sustained the Intervention10 Sites
Secondary

Change in Behavioral Problems (Guardian Report)

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.

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

ArmMeasureValue (MEAN)
Youth Randomized to Health-Sector Delivered CBTChange in Behavioral Problems (Guardian Report)-0.9 score on a scale
Youth Randomized to Education-Sector Delivered CBTChange in Behavioral Problems (Guardian Report)-0.7 score on a scale
Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBTChange in Behavioral Problems (Guardian Report)-0.04 score on a scale
Secondary

Change in Depressive Symptoms (Child Report)

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.

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

ArmMeasureValue (MEAN)
Youth Randomized to Health-Sector Delivered CBTChange in Depressive Symptoms (Child Report)-3.6 score on a scale
Youth Randomized to Education-Sector Delivered CBTChange in Depressive Symptoms (Child Report)-3.3 score on a scale
Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBTChange in Depressive Symptoms (Child Report)-2.3 score on a scale
Secondary

Change in Grief (Child Report)

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).

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

ArmMeasureValue (MEAN)
Youth Randomized to Health-Sector Delivered CBTChange in Grief (Child Report)-23.0 score on a scale
Youth Randomized to Education-Sector Delivered CBTChange in Grief (Child Report)-22.9 score on a scale
Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBTChange in Grief (Child Report)-10.8 score on a scale
Secondary

Change in Posttraumatic Stress Symptoms (Caregiver Report)

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.

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

ArmMeasureValue (MEAN)
Youth Randomized to Health-Sector Delivered CBTChange in Posttraumatic Stress Symptoms (Caregiver Report)-17.1 score on a scale
Youth Randomized to Education-Sector Delivered CBTChange in Posttraumatic Stress Symptoms (Caregiver Report)-17.1 score on a scale
Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBTChange in Posttraumatic Stress Symptoms (Caregiver Report)-8.4 score on a scale
Secondary

Change in Proportion of Children Engaged in Excessive Child Labor for Pay

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.

Time frame: 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.

ArmMeasureValue (MEAN)
Youth Randomized to Health-Sector Delivered CBTChange in Proportion of Children Engaged in Excessive Child Labor for Pay0.1 proportion of youth
Youth Randomized to Education-Sector Delivered CBTChange in Proportion of Children Engaged in Excessive Child Labor for Pay0.09 proportion of youth
Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBTChange in Proportion of Children Engaged in Excessive Child Labor for Pay0.12 proportion of youth
Secondary

Change in Proportion of Children Engages in Excessive Household Assistance Without Pay

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.

Time frame: 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.

ArmMeasureValue (MEAN)
Youth Randomized to Health-Sector Delivered CBTChange in Proportion of Children Engages in Excessive Household Assistance Without Pay0.3 proportion of youth
Youth Randomized to Education-Sector Delivered CBTChange in Proportion of Children Engages in Excessive Household Assistance Without Pay0.3 proportion of youth
Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBTChange in Proportion of Children Engages in Excessive Household Assistance Without Pay0.2 proportion of youth
Secondary

Change in Proportion of Children Reporting Any Current Substance Use

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.

Time frame: 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.

ArmMeasureValue (MEAN)
Youth Randomized to Health-Sector Delivered CBTChange in Proportion of Children Reporting Any Current Substance Use-0.01 proportion of youth
Youth Randomized to Education-Sector Delivered CBTChange in Proportion of Children Reporting Any Current Substance Use-0.02 proportion of youth
Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBTChange in Proportion of Children Reporting Any Current Substance Use0.0 proportion of youth
Secondary

Change in Prosocial Behavior (Child Report)

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.

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

ArmMeasureValue (MEAN)
Youth Randomized to Health-Sector Delivered CBTChange in Prosocial Behavior (Child Report)0.09 score on a scale
Youth Randomized to Education-Sector Delivered CBTChange in Prosocial Behavior (Child Report)0.2 score on a scale
Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBTChange in Prosocial Behavior (Child Report)0.2 score on a scale
Secondary

Safer Sex Peer Norms Score

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.

Time frame: 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.

ArmMeasureValue (MEAN)
Youth Randomized to Health-Sector Delivered CBTSafer Sex Peer Norms Score16.3 score on a scale
Youth Randomized to Education-Sector Delivered CBTSafer Sex Peer Norms Score16.7 score on a scale
Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBTSafer Sex Peer Norms Score16.5 score on a scale
Secondary

School Attendance

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

Time frame: Baseline

ArmMeasureValue (MEAN)
Youth Randomized to Health-Sector Delivered CBTSchool Attendance2.1 days
Youth Randomized to Education-Sector Delivered CBTSchool Attendance1.9 days
Youth Who Were Not Randomized to Receive Pamoja Tunaweza CBTSchool Attendance1.1 days
Secondary

TF-CBT Knowledge Score

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.

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

Population: This is a group leader-level outcome.

ArmMeasureValue (MEAN)
Youth Randomized to Health-Sector Delivered CBTTF-CBT Knowledge Score25.1 score on a scale
Youth Randomized to Education-Sector Delivered CBTTF-CBT Knowledge Score27.8 score on a scale
Other Pre-specified

Guardian-provided Social Support

Social support provided to the child by their parent or guardian, as assessed by child report in the Child and Adolescent Social Support Scale. Higher scores represent more support.

Time frame: End of 8-session Treatment (assessed up to 18 weeks)

Other Pre-specified

Intervention Acceptability

Assessed using both reflective and formative measures at the group leader level. The reflective measure is the Acceptability of Intervention Measure (AIM), with scores ranging from 1 (least acceptable) to 5 (most acceptable) calculated as a mean score to reflect the acceptability of the TF-CBT intervention in a given setting. The formative measure is the Johns Hopkins University (JHU) Implementation science case for Acceptability (using only 5 items that mapped directly onto Proctor's definition of acceptability and did not overlap with items on the AIM measure). This is not treated as a scale, and items are analyzed independently of each other.

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

Other Pre-specified

Intervention Appropriateness

A formative measure is used to assess perceived appropriateness of the TF-CBT intervention at the group leader level, with scores ranging from 1 (least appropriate) to 5 (most appropriate). This is not treated as a scale, and items are analyzed independently of each other. Six items were adapted from the Johns Hopkins University implementation measures that aligned with Proctor and colleagues' (20) definition of appropriateness. Minor changes were made to fit wording to the local context. Two additional items were developed to measure appropriateness domain content for which Johns Hopkins University items did not exist. Given challenges in creating new items, Hujig's Theoretical Domains Framework was used when possible to guide item creation (42). In the resulting 8-item measure, 4 items assessed the perceived fit of delivering TF-CBT with one's role. The additional 4 items assessed the perceived fit of delivering TF-CBT within the specific setting.

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

Other Pre-specified

Intervention Feasibility

Assessed using both reflective and formative measures at the group leader level. The reflective measure is the Feasibility of Intervention Measure (FIM), with scores ranging from 1 (least feasible) to 5 (most feasible) calculated as a mean score to reflect the feasibility of implementing TF-CBT in a given setting. The formative measure is the Johns Hopkins University Implementation science scale for Feasibility (using 12 items). This is not treated as a scale, and items are analyzed independently of each other. 2 additional items were included that inquired about the estimated hours per week that respondents felt Pamoja Tunaweza/TF-CBT would require, given the importance of this information for understanding added workload and feasibility for providers in the two contexts (On average, how many hours per week do you spend on Pamoja Tunaweza/TF-CBT \[e.g., preparing for sessions, delivering sessions, and supervision\]?).

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

Other Pre-specified

Relationship Closeness

Closeness of the child's relationship with their caregiver, as assessed by caregiver report in the Closeness subscale of the Child-Parent Relationship Scale. Higher scores represent greater closeness.

Time frame: End of 8-session Treatment (assessed up to 18 weeks)

Other Pre-specified

Relationship Conflict

Conflict in the child's relationship with their caregiver, as assessed by caregiver report in the Conflict subscale of the Child-Parent Relationship Scale. Higher scores represent more conflict.

Time frame: End of 8-session Treatment (assessed up to 18 weeks)

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026