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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH112633 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Washington | OTHER |
| Johns Hopkins University | OTHER |
| Ace Africa | OTHER |
| National Institute of Mental Health (NIMH) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health-Sector Delivered CBT | Experimental | 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. |
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| Education-Sector Delivered CBT | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trauma-Focused Cognitive Behavioral Therapy | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, End of 8-session Treatment (assessed up to 18 weeks) |
| 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. | End of first year of site implementation (2 groups, 8 sessions each) |
| 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. | End of first year of site implementation (2 groups, 8 sessions each) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | End of 8-session Treatment (assessed up to 18 weeks) |
| Relationship Conflict |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn Whetten, PhD | Center for Health Policy and Inequalities Research at Duke University | Principal Investigator |
| Shannon Dorsey, PhD | University of Washington Department of Psychology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACE Africa | Bungoma | Bungoma County | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20671888 | Background | Thornicroft G, Alem A, Antunes Dos Santos R, Barley E, Drake RE, Gregorio G, Hanlon C, Ito H, Latimer E, Law A, Mari J, McGeorge P, Padmavati R, Razzouk D, Semrau M, Setoya Y, Thara R, Wondimagegn D. WPA guidance on steps, obstacles and mistakes to avoid in the implementation of community mental health care. World Psychiatry. 2010 Jun;9(2):67-77. doi: 10.1002/j.2051-5545.2010.tb00276.x. | |
| 17804062 | Background | Saxena S, Thornicroft G, Knapp M, Whiteford H. Resources for mental health: scarcity, inequity, and inefficiency. Lancet. 2007 Sep 8;370(9590):878-89. doi: 10.1016/S0140-6736(07)61239-2. |
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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.) |
| FG001 | 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.) |
| FG002 | 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.) |
| FG003 | 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 |
| FG004 | 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 |
| FG005 | 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 |
| FG006 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants with Baseline Characteristics data collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, End of 8-session Treatment (assessed up to 18 weeks) |
|
Enrollment through final annual follow-up assessment (maximum three years post-intervention, depending on stepped-wedge sequence timing)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Youth Randomized to Health-Sector Delivered CBT | These child/adolescent participants and one of their guardians received 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Whetten, PhD, MPH | Duke University | 919-613-5313 | k.whetten@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2020 | Sep 18, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 6, 2021 | Mar 18, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| D000092862 | Psychological Well-Being |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| NIH |
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.
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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]).
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| Two years after the first TF-CBT groups for each site |
| Baseline, End of 8-session Treatment (assessed up to 18 weeks) |
| 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. | Baseline, End of 8-session Treatment (assessed up to 18 weeks) |
| 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). | Baseline, End of 8-session Treatment (assessed up to 18 weeks) |
| 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. | Immediately Post-Training (on final day of training for the sequence, up to 6 days) |
| 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. | Baseline, End of 8-session Treatment (assessed up to 18 weeks) |
| 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. | Baseline, End of 8-session Treatment (assessed up to 18 weeks) |
| School Attendance | School attendance measured by the number of school days missed in the past two weeks, as reported by the guardian. | Baseline |
| 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. | Baseline to third annual follow-up |
| 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. | Baseline to third annual follow-up |
| 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. | Third annual follow-up |
| 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. | Baseline to third annual follow-up |
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. |
| End of 8-session Treatment (assessed up to 18 weeks) |
| 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. | End of 8-session Treatment (assessed up to 18 weeks) |
| 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. | End of first year of site implementation (2 groups, 8 sessions each) |
| 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]?"). | End of first year of site implementation (2 groups, 8 sessions each) |
| 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. | End of first year of site implementation (2 groups, 8 sessions each) |
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| 33413688 | Derived | Triplett NS, Munson S, Mbwayo A, Mutavi T, Weiner BJ, Collins P, Amanya C, Dorsey S. Applying human-centered design to maximize acceptability, feasibility, and usability of mobile technology supervision in Kenya: a mixed methods pilot study protocol. Implement Sci Commun. 2021 Jan 7;2(1):2. doi: 10.1186/s43058-020-00102-9. |
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| BG001 | 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). |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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). |
| OG002 | 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. |
|
|
| 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | End of first year of site implementation (2 groups, 8 sessions each) | Sites | Sites |
|
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| 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. | This is a site level outcome indicating whether the 3-counselor team in each sector implemented the 8 sessions. | Posted | Count of Units | Sites | End of first year of site implementation (2 groups, 8 sessions each) | Sites | Sites |
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| 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. | This is a site level outcome indicating whether the 3-counselor team in each sector maintained delivery 2 years after the study intervention period. | Posted | Count of Units | Sites | Two years after the first TF-CBT groups for each site | Sites | Sites |
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| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, End of 8-session Treatment (assessed up to 18 weeks) |
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| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, End of 8-session Treatment (assessed up to 18 weeks) |
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| 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). | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, End of 8-session Treatment (assessed up to 18 weeks) |
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| 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. | This is a group leader-level outcome. | Posted | Mean | 95% Confidence Interval | score on a scale | Immediately Post-Training (on final day of training for the sequence, up to 6 days) | Group Leaders | Group Leaders |
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| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, End of 8-session Treatment (assessed up to 18 weeks) |
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| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, End of 8-session Treatment (assessed up to 18 weeks) |
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| Secondary | School Attendance | School attendance measured by the number of school days missed in the past two weeks, as reported by the guardian. | Posted | Mean | 95% Confidence Interval | days | Baseline |
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| 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. | Participants who were assessed at the third annual follow-up and were at least 16 years old at follow-up time. | Posted | Mean | 95% Confidence Interval | proportion of youth | Baseline to third annual follow-up |
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| 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. | Participants who were assessed at the third annual follow-up and were at least 16 years old at follow-up time. | Posted | Mean | 95% Confidence Interval | proportion of youth | Baseline to third annual follow-up |
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| 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. | Participants who were assessed at the third annual follow-up and were at least 16 years old at follow-up time. | Posted | Mean | 95% Confidence Interval | score on a scale | Third annual follow-up |
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| 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. | Participants who were assessed at the third annual follow-up and were at least 16 years old at follow-up time. | Posted | Mean | 95% Confidence Interval | proportion of youth | Baseline to third annual follow-up |
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| 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. | Not Posted | End of 8-session Treatment (assessed up to 18 weeks) | Participants |
| 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. | Not Posted | End of 8-session Treatment (assessed up to 18 weeks) | Participants |
| 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. | Not Posted | End of 8-session Treatment (assessed up to 18 weeks) | Participants |
| 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. | Not Posted | End of first year of site implementation (2 groups, 8 sessions each) | Participants |
| 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]?"). | Not Posted | End of first year of site implementation (2 groups, 8 sessions each) | Participants |
| 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. | Not Posted | End of first year of site implementation (2 groups, 8 sessions each) | Participants |
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| 413 |
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| 413 |
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| 413 |
| EG001 | Youth Randomized to Education-Sector Delivered CBT | These child/adolescent participants and one of their guardians received 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). | 0 | 438 | 0 | 438 | 0 | 438 |
| EG002 | Youth Who Did Not 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. | 0 | 105 | 0 | 105 | 0 | 105 |
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| D001519 | Behavior |
| D010549 | Personal Satisfaction |